UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

__________________

FORM 10-K

_______________

(Mark One)

 X.ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Fiscal Year EndedAugust December 31, 20112014

     ..TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE EXCHANGE ACT

For the transition periodTransition Period from __________________ to ______

VOLITIONRX LIMITED

(Exact name of registrant as specified in its charter)__________

Securities registered pursuant to Section 12(b) of the Act:

Securities registered pursuant to Section 12(g) of the Act:

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes     .No X.

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.

Yes     .No X.

.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.

Yes X.No     .

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes X.No     .

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.     .

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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes     .No X.

The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant as of February 28, 2011June 30, 2014 was $NIL$11,973,676 based upon the price ($NIL)1.53) at which the common stock was last sold as of the last business day of the most recently completed second fiscal quarter, multiplied by the approximate number of shares of common stock held by persons other than executive officers, directors and five percent stockholders of the registrant without conceding that any such person is an “affiliate” of the registrant for purposes of the federal securities laws. Our common stock is currently quotedtraded on the Over-The-Counter Bulletin BoardNYSE MKT and quoted under the symbol “VNRX.OB”“VNRX”.

As of November 28, 2011,March 18, 2015, there were 8,120,65217,934,715 shares of the registrant’s $0.001 par value common stock issued and outstanding.

Documents incorporated by reference: None

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Table of Contents

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FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).statements. These forward-looking statements are not historical facts but rather are based on current expectations, estimates and projections. We may use words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “foresee,” “estimate” and variations of these words and similar expressions to identify forward-looking statements. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors, some of which are beyond our control, are difficult to predict and could cause actual results to differ materially from those expressed or forecasted. These risks and uncertainties include the following:following:

·

The availability and adequacy of our cash flow to meet our requirements;

·

Economic, competitive, demographic, business and other conditions in our local and regional markets;

·

Changes or developments in laws, regulations or taxes in our industry;

·

Actions taken or omitted to be taken by third parties including our suppliers and competitors, as well as legislative, regulatory, judicial and other governmental authorities;

·

Competition in our industry;

·

The loss of or failure to obtain any license or permit necessary or desirable in the operation of our business;

·

Changes in our business strategy, capital improvements or development plans;

·

The availability of additional capital to support capital improvements and development; and

·

Other risks identified in this report and in our other filings with the Securities and Exchange Commission or the SEC.

This report should be read completely and with the understanding that actual future results may be materially different from what we expect. The forward-looking statements included in this report are made as of the date of this report and should be evaluated with consideration of any changes occurring after the date of this Report. We will not update forward-looking statements even though our situation may change in the future and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Use of Term

Except as otherwise indicated by the context, references in this report to “Company”, “we”, “us”, “our” and “VNRX” are references to VolitionRXVolitionRx Limited.  All references to “USD” or United States Dollars refer to the legal currency of the United States of America.

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PART I

ITEM 1. BUSINESS

Corporate History

The Company was incorporated on September 24, 1998 in the State of Delaware under the name Standard“Standard Capital Corporation.  The original business planCorporation”.  On September 22, 2011, the Company filed a Certificate for Renewal and Revival of Charter with Secretary of State of Delaware.  Pursuant to Section 312(1) of Delaware General Corporation Law, the Company was revived under the new name of “VolitionRX Limited”. The name change to acquireVolitionRx Limited was approved by FINRA on October 7, 2011 and develop mineral properties.  The Company leased the rights to explore a mining claim known as the Standard (the “Standard Claim”), but allowed the lease to expire in February 2008.  The Company no longer has any rights to the mineralsbecame effective on the Standard Claim nor does it have any liabilities attached to the claim.  October 11, 2011.

On September 26, 2011, the Company, then under the name Standard Capital Corporation, and its controlling stockholders (the “Controlling Stockholders”) entered into a Share Exchange Agreement (the “Share Exchange Agreement”) with Singapore Volition Pte Limited, a Singapore registered company (“Singapore Volition”) and the shareholders of Singapore Volition (the “Volition Shareholders”), whereby the Company acquired 6,908,652 (100%) shares of common stock of Singapore Volition (the “Volition Stock”) from the Volition Shareholders.  In exchange for the Volition Stock, the Company issued 6,908,652 shares of its common stock to the Volition Shareholders.  The Share Exchange Agreement closed on October 6, 2011.

As a result of the Share Exchange Agreement, Singapore Volition became our wholly-owned operating subsidiary and the Company now intends to carrycarries on the business of Singapore Volition as its primary business.  Singapore Volition has two subsidiaries, Belgian Volition SA, a Belgium registered company (“Belgian Volition”), which it acquired as of September 22, 2010, and HyperGenomics Pte Limited, a Singapore registered company (“HyperGenomics Pte Limited”).  Singapore Volition owns 99.9%, which it formed as of the issued and outstanding shares of Belgian Volition and 100% of the issued and outstanding shares of HyperGenomics Pte Limited.March 7, 2011.

On September 22, 2011, the Company filed a Certificate for Renewal and Revival of Charter (“Certificate for Renewal”) with the Secretary of State of Delaware, to reinstate the Company’s Certificate of Incorporation. Pursuant to Section 312(1) of the Delaware General Corporation Law, the Company was revived under the new name of "VolitionRX Limited."  The name change to VolitionRX Limited was approved by FINRA on October 7, 2011 and became effective on October 11, 2011.BUSINESS

Description of Our Business

The Company isWe are a clinical-stage life sciences company focused on meetingdeveloping blood-based diagnostic tests that meet the urgent need for accurate, fast, inexpensive and scalable tests for detecting and diagnosing cancer and other diseases. We arehave developed twenty blood assays to date, using technology based on our Nucleosomics^® biomarker platform, that can be used individually or in combination to generate a profile which forms the basis of a blood test for a particular cancer.

Each assay that we have developed can be commercialized for two distinct markets:

·

The clinical IVD market which can only be accessed after the assays have either been approved for clinical use in the development stageUnited States by the FDA, or as a LDT in the United States under a CLIA waiver, and by CE marking in the EU; and

·

The RUO market.

Given the much larger potential clinical IVD, market, we have decided to focus our resources on launching in the clinical IVD market. We currently plan to apply for the first of our operations and areCE Mark (European) approvals in the processsecond quarter of discovering, developing and commercializing diagnostic tests.  2015.

We believeexpect that we will be required to do further United States trials to achieve FDA approval for our colorectal cancer test. We are committed to filing for FDA approval to allow patient access to our tests willin the United States as soon as practicable. Pending completion of our review of the regulatory environment in the United States, including the effect of recent pronouncements regarding LDTs by the FDA, we aim initially to enter the United States market through a LDT in 2015, pursuant to a yet to be able to better detect and characterize cancer and other disease states than existing methods, which in turn will provide better patient outcomes and contain healthcare costs.  We focusnegotiated relationship with a CLIA lab, while we concurrently seek FDA approval.

Commercializing products on blood-based teststhe RUO market means that we intend to sell our products to medical schools, universities and commercial research and development departments for research use only. Products placed on the RUO market may be used for any research purpose. RUO products, however, are strictly not to be used for patient diagnosis. Commercializing products on the IVD market means that we intend to sell our future products to be used for patient diagnosis. None of the assays that we are currently developing are available for sale on the IVD market, and we began sales in the RUO market in 2014.

We intend to commercialize our products in the future through various channels within the EU, the United States and eventually throughout the world, subjectrest of the world. We anticipate that because of their ease of use and low cost, our tests have the potential to regulatory clearancebecome the first method of choice for cancer diagnostics, allowing detection of cancer at an earlier stage than typically occurs currently, and screening of individuals who, for reasons such as time, cost or approval.dislike, are not currently screened. We believe our blood test has the potential to have significantly higher acceptance from patients as compared to fecal tests and colonoscopies which are invasive and unpleasant, resulting in low acceptance.

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We do not anticipate earning significant revenues until such time as we able to fully market our products.intended products on either the RUO or IVD clinical diagnostics market.  For these reasons, our auditors stated in their report on our audited financial statements that they have substantial doubt that we will be able to continue as a going concern without further financing. The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish its plan of operations described herein and eventually attain profitable operations.

We anticipate that any additional funding that we will require will be in the form of equity financing from the sale of our common stock. However, there is no assurance that we will be able to raise sufficient funding from the sale of our common stock. The risky nature of our business enterprise places debt financing beyond the credit-worthiness required by most banks or typical investors of corporate debt until such time as our intended products are available on the market.  We do not have any arrangements in place for any future equity financing.  If we are unable to secure additional funding, we will cease or suspend operations.  We have no plans, arrangements or contingencies in place in the event that we cease operations.

The Market

Everyone in the world has, or will be, touched by the effects of cancer. ItCancer is one of the world’s most deadly diseases,leading causes of death worldwide, accounting for around 13% of8.2 million annual global deaths.deaths globally.¹⁵ In the United States alone, there are 13.8were an estimated 14 million cancer survivors.survivors in 2010.⁶ By 2020, this figure is expected to rise to 18.1 millionmillion. The American Cancer Society estimated the total health economic burden for cancer (including medical costs and theloss of earnings) at approximately $216 billion for 2009 ($86 billion in direct medical costs and $130 billion in lost productivity due to early death).⁷ Theannualized cost of cancer care in the over 65 age group based on analysis of Medicare payments linked to the U.S. Surveillance, Epidemiology, and End Results, or SEER, Program datais projected to reach $158 billion.^28,9 These figures are mirrored in all regions ofacross the worldglobe and we expect will continue to grow as populations age. This is a large potential addressable market offor which we believe diagnostics will be a significant part. Incidence of, and mortality due to, colorectal cancer in the US have been steadily falling since the mid 1980’s with an acceleration of reduction in both men (3% per annum) and women (2.3% per annum) over the last 15 years. This is largely due to early detection and removal of polyps via colonoscopy.¹⁰ The Pap test has had a similar impact in improving 5 year survival rates in women with precancerous and cancerous cervical lesions.¹¹

Inevitably,

_____________________

⁵ Cancer-Fact sheet N 297, World Health Organization, [online], Available at: http://www.who.int/mediacentre/factsheets/fs297/en/index.html, [accessed 11.12.2014]

⁶ Mariotto AB et al., Projections of the cost of cancer care in the United States: 2010-2020. Jan 19, 2011, JNCI, Vol 103, No.2, Available at http://www.ncbi.nlm.nih.gov/pubmed/21228314 [will begin testing the first cohort of retrospective samples in Q1 2015 10.31.2014]

⁷ American Cancer Society, Economic Impact of Cancer, 31.03.2014 [online], available at http://www.cancer.org/cancer/cancerbasics/economic-impact-of-cancer[accessed 11.12.2014]

⁸ Surveillance, Epidemiology, and End Results Programme, [online] Available at http://seer.cancer.gov [accessed 11.12.2014]

⁹ National Institutes of Health “Cancer costs projected to reach at least $158 billion in 2020”, 12 January 2011, [online], Available at http://www.nih.gov/news/health/jan2011/nci-12.htm [accessed 10.31.2014]

¹⁰ American Cancer Society, Colorectal Cancer Facts & Figures 2011-2013 [Online] available at http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-028312.pdf [accessed 11.12.2014]

¹¹ National Cancer Institute Fact Sheet: Cervical Cancer Screening (PDQ®) [Online] Available at http://www.cancer.gov/cancertopics/pdq/screening/cervical/HealthProfessional/page2 [accessed 11.12.2014]

Statistically, the chances of surviving cancer are greatly improved by early detection and diagnosis, however,treatment. However, there is currently no screening test for cancer in general, and very few effective mass screeningblood tests for specific cancers.  cancers in common clinical use. The only commonly used blood-screening test for any cancer is the PSA test for prostate cancer. We consider the PSA test to have relatively poor diagnostic accuracy (detecting approximately 70% of prostate cancers and misdiagnoses about 30% of healthy men as positive for cancer) but is widely used because it is the best product currently available.¹² The American Cancer Society recommends that prostate cancer screening should not occur without an informed decision making process regarding risks.¹³ In 2012, the U.S. Preventative Services Task Force recommended against PSA-based screening for healthy men because of a “moderate or high certainty” that the service has no benefit or that the harms outweigh the benefits”.¹⁴ The test is still used to monitor patients after definitive diagnosis or treatment. There are currently no commonly used blood tests for screening for lung cancer or colorectal cancer.

Further, current methods of cancer diagnosis are either invasive, not cost effective, andhave low acceptance or cannot provide accurate results. The inadequacy of existing diagnostic products means that most cancers are only diagnosed once the patient experiences symptoms and the cancer is well established. By this stage, it will often have spread beyond the primary tumor (metastatic cancers), making it substantially more difficult to treat. For example colorectal cancer is one of the more survivable diseases if caught early: it has an observed five-year survival rate of 92% in stage I, but only 11% in stage IV.¹⁵Early, non-invasive, accurate cancer diagnosis remains a greatsignificant unmet medical need and a huge commercial opportunity. For these reasons, cancer diagnostics is an active field of research and development both academically and in industry.commercially.

The global In-Vitro Diagnostics (IVD)IVD market is forecast to grow at a rate of 6% to reach $50.0$65 billion in 2012,2018,¹⁶ driven by the increasing health care demands of an ageingaging population. The market has been growing at a rate of 5-6% in recent years, reaching a value of $36.5 billion in 2007.In the United States,³¹⁷ The largest the IVD market segment is diabetes diagnostics with a value of $10 billion.⁴ The cancer IVD market comprising cancer blood and tissue biopsy tests was $4.7 billion in 2008 and growing at 11%.⁵

Of this the two largest IVD market segments are:made up of:

·

Histology, immunohistochemistry and cytology of tissue samples (45%(expected to grow 6.8% per annum from 2011-2018, with an expected value of IVD sales or approximately $2 billion)$25.5 billion by 2018).¹⁸ These are mostly used to confirm cancer diagnosis post-surgery and to determine cancer sub-type; and

·

Immunoassays, mostlyImmunoassay (chemical tests used to detect a substance in blood or body fluid), which will be the second largest market with a value of blood samples (30% of IVD sales or approximately $1.5 billion).more than US$19.1 billion by 2018.¹⁹ These tests are mostly used to monitor for disease progress and relapse. This market segment includes our future Nucleosomics^® products, which arewill be blood immunoassay tests for modified histones for the diagnosis and prognosis of cancer.

The IVD market (all disease areas) is highly consolidated with the top 10 companies taking an 80% market share. Roche Diagnostics is the largest single company by market share with 20%. Siemens and Abbott both have 12% market share.___________________

⁶¹² The cancer IVD market also contains many smaller development companies developing and selling novel products, such as the Company.National Cancer Institute Fact Sheet: Prostate-Specific Antigen (PSA) Test, [24 July 2012] [online], Available at http://www.cancer.gov/cancertopics/factsheet/detection/PSA, [accessed 10.31.2014]

¹³ Wolf. Aet. al.American Cancer Society Guideline for the Early Detection of Prostate Cancer: Update 2010, CA: A Cancer Journal for Clinicians; 3 Mar 2010:60;2:70-98, available at http://www.ncbi.nlm.nih.gov/pubmed/20200110 [accessed 10.31.2014]

¹⁴ U.S. Preventative Services Task Force, May 2012 [online], available at http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/prostate-cancer-screening [accessed 10.31.2014]

¹⁵ American Cancer Society. “Colorectal Cancer,” 2014 [online], Available at: http://www.cancer.org/cancer/colonandrectumcancer/detailedguide/colorectal-cancer-survival-rates, [accessed 11.04.2014

¹⁶ Report: The CompanyWorldwide Market for In Vitro Diagnostic (IVD) Tests, 9th Edition, August 13, 2014 [online], Available for purchase at: http://www.kaloramainformation.com/Worldwide-Vitro-Diagnostic-8326563, [accessed 10.31.2014]

¹⁷ Report: The United States Market for In Vitro Diagnostic Tests

Mar 18, 2014 [online], Available for purchase at http://www.kaloramainformation.com/United-States-Vitro-8079142, [accessed 10.31.2014]

¹⁸ In Vitro Diagnostics Market to 2018 - Consolidation, Decentralization and Demand for Genetic Testing to Shape the Competitive Landscape, March 23, 2012 [online], Available at http://www.marketresearch.com/GBI-Research-v3759/Vitro-Diagnostics-Consolidation-Decentralization-Demand-6871130 [accessed 11.12.2014]

¹⁹ Markets and Markets Report: Immunoassay Market [Technology (Enzyme, Fluorescent, Chemiluminescence, Radioimmunoassay), Analyzers & Reagents, Applications (Infectious Diseases, Cancer, Endocrinology, Cardiology), End Users (Hospitals, Laboratory, Academics)] - Global Forecast to 2018, October, 2013 [online], Available at: http://www.marketsandmarkets.com/Market-Reports/immunoassay-market-436.html [accessed 11.04.2014]

Testing is carried out at three principal locations:²⁰

·

Testing at hospital laboratories: $30 billion annual revenue for eight billion tests in 2011;

·

Testing at CLIA laboratories: $20 billion annual revenue for 3 billion tests in 2011; and

·

Testing at physician office laboratories: $3 billion annual revenue for 1.2 billion tests in 2011.

We are focused on responding to the need for early, accurate diagnostic tests with itsthrough the development of our proprietary Nucleosomics^TM (“NuQ^TM”) technologytechnologies and products.  The Company’sproduct prototypes. We intend to develop a range of products will continue to expand over the next 5-10 years with both generalyears. For the year ended December 31, 2013, we spent approximately $2.5 million on research and specific cancer tests,development activities. For the year ended December 31, 2014, we spent approximately $4.0 million on increasingly simple formats.

¹

Cancer - Fact sheet N°297,World Health Organization, [online], Available at: http://www.who.int/mediacentre/factsheets/fs297/en/index.html,[accessed 8.23.2011]

²

Mariotto AB et al., Projectionsresearch and development activities. None of the cost of cancer care in the United States: 2010-2020. Jan 19, 2011,JNCI, Vol 103, No.2

³

The Top Ten Global In-Vitro Diagnostics Companies, March 6, 2009, [online], Available at:  http://store.business-insights.com/Product/?productid=BI00021-001, [accessed 8.29.2011]

⁴

Diagnostics: Testing systems prove their worth, July 1, 2008, [online], Available at: http://www.ft.com/cms/s/0/47c5ec16-477e-11dd-93ca-000077b07658,dwp_uuid=322c9222-4712-11dd-876a-0000779fd2ac.html, [accessed 8.29.2011]

⁵

Cancer IVD market expands to meet customer demand, May 1, 2008, [online], Available at:  http://www.ivdtechnology.com/article/cancer-ivd-market-expands-meet-customer-demand, [accessed 8.29.2011]

⁶

The Top Ten Global In-Vitro Diagnostics Companies, March 6, 2009, [online], Available at:  http://store.business-insights.com/Product/?productid=BI00021-001, [accessed 8.29.2011]

these costs are borne directly by customers.

Our Intended Products

The Company’s existingCommercialization of our future products as well as thoseon the clinical IVD market (e.g. for patient diagnosis in hospitals, clinics, etc.), requires government approval (CE Marking in Europe and/or FDA approval in the United States). We plan to begin the approval process in the EU and the United States in 2015. Commercializing our products on the RUO market (e.g. for uses other than patient diagnosis in medical schools, universities and commercial research and development departments, etc.) does not require government approval. However, before any of our products can be sold on the RUO market, they need to successfully complete beta-testing. Beta-testing involves providing the products to a few laboratories to identify and correct any problems in the products. None of the products that we are currently developing are available on the IVD market; however, we began sales in the development pipeline,RUO market in 2014. The products that we are currently developing are described in detail below:

NuQ^TM® Suite of Epigenetic Cancer Blood Tests

We have developed twenty epigenetic NuQ^® assays using our Nucleosomics^®technology which are designed to detect the level and structure of nucleosomes in blood. Epigenetics is the science of how genes are switched “on” or “off” in the body’s cells. A major factor controlling the switching “on” and “off” is the structuring of DNA. The DNA in every human cellcells is not a random string but wound aroundpackaged as protein complexes in a “beads on a string” structure. Each individual “bead” with associated protein/DNA coiled around it“bead” is called a nucleosome. These nucleosomes then form additional structures with increasingly dense packing, culminating in chromosomes containing hundreds of thousands of nucleosomes.

Figure 1 – A nucleosome

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²⁰ Report: The United States Market for In Vitro Diagnostic Tests Mar 18, 2014 [online], Available for purchase at http://www.kaloramainformation.com/United-States-Vitro-8079142/, [accessed 11.12.2014]

Cancer is characterized by uncontrolled and often rapid cell growth and also by an approximately matched, but slightly less, rapidwhich exceeds the corresponding rate of cell death rate.death. When the cells die, the DNA is chopped upfragments into individual nucleosomes which are released into the blood as summarizedillustrated in Figure 2 below. When cells break up, they end upThe cell debris in the bloodstream to beis eventually recycled back into the body. When a cancer is present, the number of dying cells being recycled is far higher than in a healthy body, socan overwhelm the system is overwhelmed,recycling process, leaving the excess broken-up pieces,fragments, including the nucleosomes, in the blood.

The Importantly, the structure of nucleosomes is not uniform but subject to immense variety. It is has been known for 4 or 5 years thatvariety, and nucleosomes in cancer cells are differenthave differences in structure from those in healthy cells.¹²¹ The Company has developed tests for some of the major nucleosome varieties and we have shown that we can detect the nucleosome patterns that are specific to cancer in the blood. Furthermore, we have shown that the nucleosome varieties also differ between cancer types (to distinguish for example between cancer of the pancreas, colon or mouth).

¹

Fraga MF et al., “LossFigure 2 – Release of acetylation at Lys16 and trimethylation at Lys20 of histone H4 is a common hallmark of human cancer”,Nature Genetics, Vol 37 (4), p391-400, 2005

nucleosomes into blood

Blood nucleosome levels arecan be raised in conditions other than cancer including in auto-immune disease, inflammatory disease, endometriosis, sepsis, and in the immediate aftermath of major trauma (for example following a heart attack, surgery or car accident). The Company’sOur primary focus is on cancer diagnosis but we will also intend to pursue diagnostic opportunities in other disease areas.

The Company’sTo date we have developed 20 NuQ^TM®blood test productsassays that fall into 4the five main types set forth below and willare intended to complement each other and, together, to provide a total solution:solution. To date, we do not have any products available for sale on the IVD market.

·

NuQ^TM®-X: A general test forWe are currently developing two blood assays in the detectionNuQ^®-X family to detect the presence of the level of allcancer by detecting nucleosomes in a patient’s blood.containing specific nucleotides.

·

NuQ-XNuQ^TM®-V: We are currently have two testsdeveloping three blood assays in the NuQ-XNuQ^TM® family. They are tests for the detection of nucleosomes containing specific nucleotides are used as a blood test for the presence of cancer. So far we have tested blood samples from lung, colon, pancreatic and oral-V family to detect cancer patients taken on diagnosis prior to treatment. To date, every blood sample taken from patients with cancer that we have tested is clearly positive in both of the NuQ-X^TM tests (100%). All blood samples taken from healthy patients have tested clearly negative in both tests (0%). Further clinical testing is necessary, but NuQ-X^TM tests have great potential to fulfil the “holy grail” of a simple screening blood test for cancer.

·

NuQ-V^TM: We currently have four tests in the NuQ-V^TM family. These are tests for the detection ofby detecting nucleosomes containing specific histone variantsand are used as a blood test for cancer. Additionally,variants. Through our research, we have found that the pattern of blood levels of the different types of histone variants in nucleosomes is different for different cancer types. NuQ-V^TM test levels are raised in 85% of blood samples taken from patients with cancer that we have tested to date and, as well as detecting cancer, the patterns can distinguish between different cancer types. The Company will develop further NuQ-V^TM tests to distinguish all the main cancer types and to increase the cancer detection rate of NuQ-V^TM even higher from 85%.

·

NuQ-MNuQ^TM®-M: We are currently have one testdeveloping nine blood assays in the NuQ-MNuQ^TM® family. This test is for the detection of-M family to detect cancer by detecting nucleosomes containing modified histones, the proteins that package and order DNA into nucleosomes, and can be used asnucleosomes.

·

NuQ^®-A: We are currently developing five blood assays in the NuQ^®-A family to detect cancer by detecting nucleosome-protein adducts.

·

NuQ^®- T: We are currently developing a NuQ^®-T assay to detect cancer by detecting total blood test for cancer. Our developmentnucleosome levels.

Generally, the tests described above are being developed to work with this family of tests is at an earlier stage. The Company will develop many more such tests andin combination, collectively called the intention is to use them in a similar way to that describedNuQ^® panel, for the NuQ-VIVD market. In our biggest independent clinical trial to date, we have used the NuQ^TM® tests above.panel prototypes to test approximately 938 samples from patients with symptoms associated with colorectal cancer (the “Denmark Trial”). Additionally the NuQ^® panel prototypes have been used to test a small number of blood samples from lung and prostate cancer patients.

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²¹ Fraga MF et al., “Loss of acetylation at Lys16 and trimethylation at Lys20 of histone H4 is a common hallmark of human cancer”, Nature Genetics, Vol 37 (4), p391-400, 2005

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NuQ^® Research Kits

We believehave launched our first RUO products will enable doctorsfor use in cell culture in 2014, although we have decided to screen for cancer using a NuQ-X^TM test with a high detection rate (we have observed a 100% detection rate to date) and, if cancer is detected, to use NuQ-M^TM and NuQ-V^TM tests to investigate which cancer is present  (up to 85% accuracy of those tested to date).

The Company will bring its suite of NuQ^TM blood tests tofocus our limited resources on clinical products in 2015 after our encouraging initial results in the market at the end of 2011 to meet the strong need for cancer diagnostics.

NuQ^TM Research Products

The Company has already developed a number of NuQ^TM tests that it is using for clinical validation. In addition to their applicationDenmark trials in diagnostics, these products are useful research tools and will be marketed for research use.

The Company is currently organizing the manufacture of its first research use products and will commence sales in late 2011.colorectal cancer. The research products are 96 well semi-manual kits for the simultaneous analysis of 96 blood48 samples, (thethe usual format for research products)products (a 96 well kit can be used to analyze some 48 samples in duplicate). The most expensive component in the manufacture of products areis the pairs of antibodies employed. Initially, these will be bought inare purchased or licensed in aton a cost of $14-$94 per kit (for the lowest and highest cost pairsmall scale, but we are currently using), but the Company hashave commenced development of itsour own antibodies which we believe will reduce costs. Total small scale production costs, to less than $10for our lowest cost kit is currently $130 per kit. Other production costs are less than $30This kit is marketed at $495 to the end user. The more expensive kits currently cost $300 per kit to manufacture and have selling prices between $795 - $1275 per kit. Total initial production costs will be around $50-$125 (or $2-$4 per test as samples are usually tested in duplicate, so that a 96 well kit can be used to analyze some 48 samples) and weWe anticipate a subsequent dropreduction in the production price the first year to approximately $40$100 per kit. The selling price will be in the region of $700 - $1200. A mock-up of a typical kit, is shown in Figure 3 below.

as we continue to develop our own antibodies.

The NuQ^TM® assay technology is proprietary to us so no direct competition exists. However, some competitors manufacture simple generic modified histone ELISA kits, which are the closest competitors currently on the market, to our intended NuQ^®-M products. The generic products offered by competitors do not measure modified histones in intact nucleosomes but require chemical extraction of histones from samples prior to use.

The NuQ^® research use kits are designed to run on simple instrumentation available from a wide range of suppliers and found in everymost research laboratorylaboratories and hospital.hospitals. Our own instrument, on which we develop and run the NuQ^TM® tests, is shown in Figure 43 below.

Figure 3 – Example of lab instrument for running ELISA tests

NuQ^TM® Clinical Diagnostic Products

There are three main segments toof the clinical IVD market addressed bythat we intend to adapt our future NuQ^® products to in the Company’s products, and the NuQ^TM tests will be adapted for each of these segments.future.

·

Centralized High-Throughput, Hospital LaboratoriesLaboratory Market

Centralized laboratories test thousands of blood samples taken from patients everyday mostly using fully automated enzyme-linked immunosorbent assay, (“ELISA”)or ELISA, systems, commonly known as random access analyzers, usually supplied by one of the global diagnostics companies. Tests run on ELISA systems use components of the immune system and chemicals to detect immune responses in the body. ELISA instruments are used in all major hospital for the analysis ofsystems analyze thousands of blood samples every day and can run dozens of different ELISA tests in any combination on any sample and for many samples simultaneously. The systems are highly automated and rapid (as little as 10 minutes for many tests), and can be run at low costs. Additionally, ELISA instruments are used in all major hospitals throughout the United States and Europe and therefore, are well understood by clinicians and laboratory staff. It is more cost-effective and technically simple for hospitals and clinics to run several blood samples simultaneously using ELISA tests compared to non-ELISA tests or alternative methods for screening cancer. All of the NuQ^®tests that we are in the process of developing are designed for ELISA systems. A typical example of an automated ELISA system is shown below in Figure 5.  Our NuQ^TMproducts are all4.

Figure 4 – Example of an Automated ELISA tests; thus, we anticipate that our tests will be adopted quickly in the healthcare market because ELISA tests are widely used and well understood by clinicians and laboratory staff.

The patient diagnostics market is much larger than the research use market. However, healthcare providers operate strong cost control policies, and the global diagnostics companies that manufacture random access analyzers (e.g. Abbott) compete on market share and operate on a low price/high volume basis. The analyzers themselves are usually provided at no immediate cost in which the laboratory is “given” the instrument in return for agreeing to purchase minimum test numbers at given prices for a given time (this is somewhat similar to consumer mobile telephone contracts in which the phone itself is provided “free”). When the contract is complete the customer gets a “free upgrade” to the latest instrument upon signing a new contract.System

One option openthat may be available to us in the Companyfuture is to license our NuQNucleosomics^TM® technology on a non-exclusive basis to a global diagnostics company, withcompany. As of the date of this Report, we do not have an estimated revenue on such a license of approximately $10 per test. The otheranticipated timeframe for licensing our Nucleosomics^® technology.

Another option which is the usual way that small innovative companies with high value ELISA products enter the centralized laboratory market,may be available to us is to sell manual and/or semi-automated 96 well ELISA plates for use by these laboratories. InAs of the date of this way, small ELISAReport, we have not entered into any discussions or negotiations with diagnostic companies are able to command prices infor the rangesale of $20-40 per test, dependent on the clinical benefit and health care cost saving benefits of the particular test. We have conducted end user research with the heads of centralized laboratories and we believe the Company’s products will command the high end of this price range.

ELISA plates.

·

Point-of-Care Devices: ThesePoint-of-care devices are small instruments that perform tens of ELISA tests per day rapidly on blood taken from a finger prick. The instruments can be foundimplemented in any oncology clinic and tests can be performed during patient consultations. The Company willWe intend to contract with an instrument manufacturer to produce these instruments for point-of-care NuQ^TM® testing for the oncologist’s office, general doctor’s office or at home testing. See Figure 6 for an example of a point-of-care device.  The Company expectsWe aim to enter the point-of-care clinical market in 2013,Europe in 2017 and in the United States in 2018, as the Companywe will first need to adapt its teststest prototypes to these small instruments and demonstrate their success in the greater diagnostics market before these products will be adopted by others in the industry. At this stage of its development, we cannot accurately predict the costs to manufacture these devices or their selling price. As of the date of this Report, we have not entered into any discussions or negotiations regarding the manufacture or sale of these devices. See Figure 5 for an example of a point-of-care device.

Figure 5 – Example of a Point-of-Care Device

The above photograph is an illustration of our intended products. To date, we have no products available for sale on the IVD market and there is no guarantee that any such products will be developed or commercialized on such market.

·

Disposable Home Use orTests for Doctor’s Office Tests:or Home Use: TheseDisposable tests for use in a doctor’s office or at home are single shot disposable devices which can be provided by a clinician as part of a screening program or purchased over the counter at any chemist shop thator pharmacy and test a drop of blood taken from a finger prick. The test iscan be administered at a doctor’s office using a point-of-care device or performed at home using a home testing kit, neither of which require laboratory involvement. Thus, the patient experiences considerably lower costs using these tests as compared to traditional laboratory tests.

The Company will contract withformat of the self-use home testing kit is very easy to use and reproduce and does not rely on laboratory processing. There are currently no useful diagnostics tests suitable for mass screening for cancer in general through a specialist company to adapt the NuQ^TM tests to this doctor office orsimple self-use home use system and contract with their manufacture. The sale of these tests will initially be for professional use only and will likely be released at a later time for non-professional use.testing kit. Figure 76 below shows a basic home use test on the left which displays the results of the test in the two windows, similar to a pregnancy test. The test on the right is more sophisticated and plugs into a meter or the USB port of a computer for analysis and interpretation.interpretation allowing results to be sent directly to a clinician.

Figure 6 – Examples of Disposable Doctor’s Office or Home Use Tests

The self-useabove photograph is an illustration of our intended products. To date, we have no products available for sale on the IVD market and there is no guarantee that any such products will be developed or commercialized on such market.

We intend to contract with a specialist company to adapt the NuQ^® test prototypes to the doctor’s office or home testing kit market is massiveuse system and to contract with a manufacturer for the production of these tests beginning in size and potentially highly profitable, as the format is very easy to use and reproduce and does not rely on laboratory processing. There are currently no useful diagnostics tests suitable for mass screening for cancer in general through a simple point-of-care or self-use home testing kit.  About 30%2017. As of the population in developed countries are overdate of this Report, we have not entered into any agreements of contracts with a specialist company or manufacturer. Initially, we intend to sell these tests for professional use only (doctor’s office) and to sell the age of 50 and would be likely candidatestests for mass cancer screening, were such atnon-professional home tests available.  On a 5-yearly screen basis, the Company estimates this represents some 40 million tests per annum in the U.S. and Europe, for which we would expect to conservatively selluse at a later time. We do not yet have an estimated timeframe for entering into this market. Further, at this early stage of our development, we cannot accurately determine the manufacturing costs or selling price of at least $30-40 per test.  The tests are expected to cost approximately $5-6 each to manufacture. Given that the price charged to the user should be approximately $30-$40, the margin appears very attractive and the cost benefit to the patient compelling.  The potential total market size for NuQ^TM self-tests is over a billion dollars annually, based on 30 million test sales worldwide per year.

these tests.

HyperGenomicsNuQ^TM® tests for non-cancer conditions

The Company isBlood nucleosome levels can be raised in the process of developing its HyperGenomics^TM tests, which will be administered onceconditions other than cancer has been detected to accurately determine the specific subtype ofincluding in auto-immune disease, and to help decide the most appropriate therapy. Selecting the correct treatment approach can significantly improve outcome, reduce side effects and deliver cost savings.  The Company believes the hypergenomic technology has the potential to be as ground breaking and revolutionary as our NuQ^TM suite of tests, as HyperGenomics^TM-based tests would provide detailed information on the specific cancer and the individual’s prognosis, and would help guide treatment.

The Company estimates that 10 million biopsy tests are performed annually in the U.S. with over a million in prostate cancer alone. Around 240,000 of these are positive and would be suited for hypergenomic profiling. A similar number are performed in Europeinflammatory disease, endometriosis, sepsis, and in the restimmediate aftermath of major trauma (for example following a heart attack, surgery or car accident). Our primary focus is on cancer diagnosis but we also intend to pursue diagnostic opportunities in other disease areas. Our primary non-cancer focus is the world. Such tests command high prices. For example Mammaprint,development of a prognostic gene arraytest for predicting breast cancer recurrence, has a list price of $4250/€2675 with over 14,000 tests carried out since approval by the FDA in 2007. On the reasonable basis that a HyperGenomics^TM test would be priced comparatively, the potential annual market size for HyperGenomics^TM tests would be in the hundreds of millions of dollars within 5 years.

The Company will spend the fourth quarter of 2011 and the first quarter of 2012 in technical validation of this technology.  In parallel, a pre-assembled kit will be developed to service the rapidly expanding life-science/epigenetics research community and will complement the Nu-Q^TM range of epigenetics research tools and kits.  In addition to continued method refinement of the HyperGenomics^TM technology, the Company will develop a robust bioinformatics platform, which shall combine the HyperGenomics^TM technology with computer science and information technology, to process and analyze data and store information. The Company expects its HyperGenomics^TM products to be rolled out onto the market within the next two years.

Endometriosis Testendometriosis.

Endometriosis is a progressive gynecological condition that affects one in ten women of childbearing age and approximately 176 million women worldwide. The disease is the leading cause of infertility in women, with up to 40% of all infertile women suffering from endometriosis. ThereAt present, there is currently no existing non-surgical diagnostic test for endometriosis. Diagnosis is typically made via invasive and expensive laparoscopy, followed by a histological examination of any lesions found to confirm the diagnosis. DueTime to difficulties in this process, the diagnosis can take approximatelyup to 9 years from when the symptoms appear. The lack of a suitable screening test has also held up development of a cure for the disease.

Singapore Volition acquired the patent application for an endometriosis test in June 2011 and the Company iswe are now in the process of developing the test based on itsour existing NuQNucleosomics^TM® technology. TheWe designed the test willto be a simple blood test taken at two stages of a woman’s menstrual cycle, during menses and partway through the month. If the two measurements show quantitative differences in total nucleosome level, endometriosis is indicated.

Hypothesis-testing We are currently conducting hypothesis-testing and clinical proof of concept work (to demonstrate that the test is feasible or has the potential to be used and is effective) on the endometriosis test is currently being carried out in our laboratory. We completed pilot studies of the Company’s laboratory. The Company will continue with validation of its NuQ^TM based endometriosis tests through the fourth quarter of 2011. The Company will review the best ways of commercializing a producttest in the late first quarter of 2012 if the validations continue to prove its diagnostic potential.   If the Company is successful in developing a reliable test, we believe that there would be significant interest from large pharmaceutical companies in partnering with the Company.

Product Development

The Company’s first products, the epigenetic cancer blood tests based on our proprietary NuQ^TMtechnology, are in development and will be released for research use byreceive the first quartersamples from The University of 2012.  

The Company will focus its energies in 2012 on bringing its NuQ^TM, NuQ-X^TM and NuQ-V^TM products to the market, while secondarily working on the proof of concepts and validations for NuQ-M^TM, Hypergenomics (“NuQ-IHC”) and Endometriosis (“NuQ Endo”) products.

A graphic representation of the developmental stage of each of the Company’s product lines at the end of third quarter of 2011 is as follows:

Plan of Operations / Sales and Marketing Strategy

The first use of our NuQ^TM products will be for research, as the research market has lower regulatory barriers and is faster to adopt new products than the clinical diagnostics sector.  We believe that by selling our products in the research market, we will drive awareness of our Company and our products which in turn, will lead to future sales in both the research and clinical markets.  The Company’s products will be available for purchaseOxford in the first quarter of 2012 to researchers via the Company’s product website, http://www.nucleosomics.com.  Initially, the Company2015 as part of a larger endometriosis study. The University of Oxford will provide serum and plasma samples from approximately 350 patients with endometriosis and 150 control patients over a period of two years. The test is too early in its development for us to accurately determinate the manufacturing costs and sale price of the test. The test is not currently being developed for the RUO market.

HyperGenomics^®

We are in the process of developing HyperGenomics^® tissue and blood-based tests to determine disease subtype following initial diagnosis and to help decide the most appropriate therapy. Although as with the Nucleosomics^® RUO kits, we have decided to focus on our clinical Nucleosomics^®products in 2015, and only continue with background work in HyperGenomics^® until we have the capital and management resources to four carefully chosen opinion leadersdo multiple programs concurrently.

Selecting the correct treatment approach can significantly improve outcome, reduce side effects and deliver cost savings. The HyperGenomics^® tests will be performed on cancer tissue obtained either by biopsy or during surgical resection to determine the cancer subtype and to determine optimal treatment regimens. The HyperGenomics^® profiling tests are being developed to provide further validationdetailed epigenetic characterization of tumors in a cost effective way. A new protocol for analyzing white blood cells – a precursor to applications in leukemia - was developed in 2012. We commenced development of a bioinformatics pipeline to analyze the complex data sets generated from the biological samples in 2012 and product feedback.  continued development of the algorithms in 2013. We aim to file new in house methodology patents for HyperGenomics^® in 2015.

We realized our first revenue of $50,000 from contract research in 2012. We will allocate resources to the HyperGenomics^® research kit as soon as is practical given our focus on the Nucleosomics^® clinical products in 2015, Beta-testing is expected to take approximately six (6) months to complete once initiated and we expect it to cost approximately $50,000. If beta-testing is successful, we expect to launch HyperGenomics^® research kits into the RUO market in Europe and in the United States.

The Company intends to choose a sales partnerlaunch of the HyperGenomics^® test into the IVD market in Europe and the United States will follow the commercialization of the test into the RUO market. The estimated timeframe for its launch into the IVD market has not yet been determined and will depend upon the speed of clinical trials and market approval. The HyperGenomics^® test is too early in its development for us to accurately determinate the manufacturing costs and sale price of the test.

Validation Studies

We have two main validation studies currently underway in colorectal cancer and two smaller studies:

·

A retrospective symptomatic study with Hvidovre Hospital in Denmark with full access to all Danish national registries and databases analyzing approximately 4,800 previously collected samples from patients with colorectal cancer, polyps or adenomas, benign bowel diseases, or other malignancies, all of whom have undergone a colonoscopy (the “Retrospective CRC Trial”).

The Retrospective CRC Trial is designed to (i) establish a NuQ^TM® research productsprofile for the detection of colorectal cancer in an initially blinded cohort (“Phase I”); and (ii) validate that profile in a second blind cohort (“Phase II”). As part of Phase I, at the end of the third quarter 2014, approximately 20% of the Retrospective CRC Trial samples have been analyzed with a combination of NuQ^® assays. Additional NuQ^®assays are currently being tested on these Phase I samples. Phase II will commence using the best NuQ^® assays on the blind sample cohort in 2015 with the results intended to be used to support CE marking of specific NuQ^®assays.

·

A prospective colorectal cancer study with Hvidovre Hospital in Denmark with 14,000 samples to be collected over 20-24 months from April 2014 from patients who have had a fecal occult blood test (“FIT Test”). Patients who tested positive following the FIT Test will additionally have a colonoscopy and we have full access to these results and the patient’s medical history. It is anticipated that 8,000 samples will be collected from patients who tested positive following a FIT Test and 6,000 samples from patients tested negative. The Prospective CRC Study is designed to evaluate the performance of the validated NuQ^® panel from the Retrospective CRC Trial in a large non-symptomatic cohort. The samples will be analyzed in batches throughout the collection period.

13

30

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and

Stockholders of Standard Capital Corporation

(A Pre-exploration Stage Company)VolitionRx LTD

We have audited the accompanying consolidated balance sheets of Standard Capital Corporation (a Pre-exploration StageVolitionRx LTD (the Company) (the “Company”) as of AugustDecember 31, 20112014 and 2010,2013 and the related consolidated statements of operations, changes in stockholder’s deficiency,stockholders’ equity and cash flows for eachthe years then ended. These financial statements are the responsibility of the years in the two—year period ended August 31, 2011, and for the period September 24, 1998 (date of inception) to August 31, 2011. The Company’s management is responsible for these financial statements.management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the auditaudits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The companyCompany is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our auditaudits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company’sCompany’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion the financial statements referred to above present fairly, in all material respects, the financial position of Standard Capital Corporation (a Pre-exploration Stage Company)VolitionRx LTD as of AugustDecember 31, 20112014 and 2010,2013, and the results of itstheir operations and its cash flows for each of the years in the two-year periodthen ended August 31, 2011, and for the period September 24, 1998 (date of inception) to August 31, 2011, in conformity with accounting principlesU.S. generally accepted in the United States of America.accounting principles.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. TheAs discussed in Note 2 to the consolidated financial statements, the Company will need additional working capital to service its debthad accumulated losses of $19,509,451 and for its planned activity,negative cash flows from operations as of December 31, 2014, which raises substantial doubt about its ability to continue as a going concern. Management’s plans in regard toconcerning these matters are also described in the notes to the financial statements. TheseNote 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

/s//s/ MadsenSadler, Gibb & Associates, CPA’s, Inc.LLC

Murray, UtahSalt Lake City, UT

November 10, 2011

March 18, 2015

F-1

VOLITIONRX LIMITED

(Formerly Standard Capital Corporation)

(A Pre-Exploration Stage Company as of August 31, 2011)

Consolidated Balance Sheets

(Expressed in US dollars)

BALANCE SHEETS