·

Belgian Volition authored the following patent application covering its NuQ^®-V technology:

NuQ-VNuQ^®-V Patent UK1115098.4andU.S. 61530304:Method for Detecting Nucleosomes containing Histone Variants

Application Date: September 1, 2011

Status: Pending Worldwide

in Europe, United States, Canada, Australia, South Africa, India, Brazil, Japan, China, Singapore, Russia, South Korea, Mexico

·

Singapore Volition authored the following patent application covering its NuQ^®-X technology:

NuQ-XNuQ^®-X Patent UK1115095.0 and U.S. 61530295: Method for detecting Nucleosomes containing Nucleotides

Application Date: September 1, 2011

Status: Pending Worldwidein Europe, United States, Canada, Australia, South Africa, India, Brazil, Japan, China, Singapore, Russia, South Korea, Mexico

·

Singapore Volition authored the following patent application covering a NuQ®NuQ^®-A blood test for detecting nucleosome adducts of cancer origin that circulate in the blood of cancer patients. The patent application covers both the use of these adducts as biomarkers and the methods for their detection.

NuQ-ANuQ^®-A Patent UK1121040.8UK112130.5 and U.S. 61568090: Method for detecting Nucleosome Adducts

Application Date: December 7, 2011

Status: Pending Worldwide

HyperGenomicsÒ Intellectual Propertyin Europe, United States, Canada, Australia, South Africa, India, Brazil, Japan, China, Singapore, Russia, South Korea, Mexico

·

HyperGenomics Pte Limited holds a worldwide exclusive licence toSingapore Volition authored the following patent application from Imperial College, London:covering NuQ^®-M blood tests for detecting nucleosomes containing modified histones of cancer origin that circulate in the blood of cancer patients. The patent application covers methods for their detection.

HyperGenomics WO03004702:  NuQ^®-M US1770893:Method for Determining Chromatin Structuredetecting Histone Modifications in Nucleosomes

Application Date: July 5, 2001February 28^th, 2013

Status: Pending in EuropeWorldwide

·

Singapore Volition was the applicant for and U.S.has been assigned the following patent:

US61770922: Method for Predicting Therapy Efficacy using Nucleosome Structure Biomarkers

Application Date: February 28^th, 2013

Status: Pending Worldwide

Endometriosis Intellectual Property

·

Singapore Volition authored the following patent application for its endometriosis test:

Endometriosis Diagnostic UK1012662.1:Method for Detecting the Presence of a Gynaecological Growth

Application Date: July 28, 2010

Status: Granted in Australia; Pending Worldwidein United States, Canada, Europe

16

Future Intellectual Property Strategy

The Company intendsWe intend to continue itsour development of the NuQNucleosomics^® and HyperGenomics^® technologies and will continue to apply for patents for future product developments. The Company’sOur strategy is to protect thetechnologies with patents in Europe and the U.S. Following product development,The protection of the technologies underlying products will then provide multiple cover for each product,based on the technologies, will be further protected individually by new patent filings worldwide.

product. We believe that this will provide:

·

Market exclusivity through a double layer of patent protection (primarily the protection of the underlying technology on which all the tests are based and, secondarily, specific patentmultiple protection for each future product).product.

·

A full 20-yearFull protection reaching at least to 2031 for each new product developed (e.g. ausing the NuQ^® product developed in 2013 would continue to be protected in all markets until 2033, beyond expiration of the parent technology patent in 2023).

-X, NuQ^®-V and NuQ^®-A technologies.

Trademarks

·

Europe – Granted Trademarks  

o

NuQ(covers associated brand namesWe also own a number of trademarks that protect our marks including NuQ-X, NuQ-V, NuQ-M, NuQ Endo, etc.)

European Community Trade Mark No. 009979675

In Classes 01, 05, 10. 42

Registration Date: November 28, 2011

Initial Duration:  10 years

From:  May 19, 2011

o

Hypergenomics

European Community Trade Mark No. 009979626

In Classes 01, 05, 10. 42

Registration Date: November 28, 2011

Initial Duration:  10 years

From:  May 19, 2011

o

Nucleosomics

European Community Trade Mark Application No. 009979551

Registration Date:  March 27, 2012

Classes 01, 05, 10. 42

Application Date: May 19, 2011

·

United States – Granted Trademark

o

Hypergenomics

US Trade Mark No. 4196778

In Classes 01, 05, 10. 42

Registration Date: August 28, 2012

Initial Duration:  10 years

From: August 28, 2012

o

NuQ

US Trade Mark No. 4228623

In Classes 01, 05, 10. 42

Registration Date: October 23, 2012

Initial Duration:  10 years

From: May 19 2011

o

Nucleosomics

US Trade Mark No. 4208619

In Classes 01, 05, 10. 42

Registration Date: September 18, 2012

Initial Duration:  10 years

From: May 19 2011“NuQ^®,” “Nucleosomics^®” and “HyperGenomics^®.”

Government Approval

All of the Company’sour intended products are designed to be non-invasive, meaning they cannot harm the subject other than through misdiagnosis. The Company’sOur strategy is to begin selling its future products for RUO purposes, which requires no regulatory approval, while simultaneously goinggo through the process of obtaining regulatory approval for IVD products to be used clinically on cancer patients. Conformité Européenne, (“CE”)or CE Marking, is a rough equivalentmandatory conformity mark for certain products placed on market in the European Union including, medical devices and IVD tests. CE Marking ensures that the manufacturer’s product conforms to the essential requirements of the United States’ Foodrelevant European health, safety and Drug Administration (“FDA”) approvals process, although it is a somewhat lighter regime.  The Company willenvironmental protection legislation. We intend to first focus on theobtaining regulatory processapproval in Europe (CE Marking), due to the grant of the NuQ^® patent in Europe and due to the lighter regulatory requirements to obtainrelatively fast European CE Marking than to obtain FDA approval in the U.S.  Thisprocess. We currently anticipate this will be followed closely by the regulatory processlicensing to CLIA labs for a LDT in the U.S.United States, and/or regulatory submissions in the United States and in the rest of the world. In many territories, the European CE Mark is sufficient to place products on the clinical market and, where it is not, it often simplifies the regulation processes. To date, the Company haswe have not begun the CE Marking or FDA approval process for any of itsour tests currently under development.

Europe – Europe–CE Marking

Manufacturers in the European Union (“EU”) and abroad must meet CE Marking requirements, where applicable, in order to market their products in Europe. The CE Mark certifies that a product has met EU health, safety, and environmental requirements which ensure consumer safety.

To receive the CE Mark, the Companyour diagnostic products must meet certain requirements as set forth in the In-Vitro Diagnostic Medical Devices Directive which applies to the Company’s diagnostic products.Directive. The requirements to procure CE Marking for In-Vitro Diagnostic Medical products are: (i)

·

analytical validation of the products; (ii)

·

clinical validation of the products (which can be retrospective clinical studies using biobank patient samples, i.e. blood samples from historic patients); (iii)

·

implementation of regulatory compliant manufacture;

·

implementation of a Quality System; and (iv)

·

certification from the International Organization for Standardization (this last requirement is not technically required but will aid the regulatory approval process in Europe and the U.S.)United States).

The Company isWe are currently engaged in the first two requirements (i) and (ii)listed above for the first NuQ^®-X test and the NuQ^® panel.  Requirements (iii) and (iv)assay. The remaining requirements listed above are general requirements that apply to all of the Company’sour intended products. In compliance with the In-Vitro Diagnostic Medical Devices Directive and the CE Marking process, the Company haswe have ensured that all development and validation is carried out in a manner consistent with regulatory approval. Additionally, the Company haswe have maintained proper records so that itsour future products can be approved as quickly and simply as possible. The Company hasWe have engaged a regulatory advisor to lead the Company in meeting the last requirement (iv) for all of itsour future products. All of these requirements must be completed prior to the submission of an application for CE Marking. The CompanyWe will submit applications, which will contain a dossier of all relevant analytical, clinical and manufacturing data following retrospective clinical studies which we expect will require a total of approximately six (6) months to complete. We estimate the cost of obtaining CE Marking will be approximately $500,000 USD per test.  The Company expects thatNuQ^® panel. We expect to apply for CE Marking for the NuQ^®-X test and NuQ^® panel products will be applied for by the end of 2013 or the first half of 2014.assay in 2015. Sales of our clinical products can occur in Europe once CE Marking has been granted.

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In Europe, IVD companies are able to self-certify that they meet the appropriate regulatory requirements and are subject to inspection for enforcement. European national agencies, such as Customs authorities and/or the Departments of Health, Industry and Labor, conduct market surveillance to ensure the provisions of the applicable Directive have been met for products marketed within the European Union. In pursuit of this goal, surveillance authorities will: i) visit

·

audit commercial, industrial and storage premises on a regular basis; ii) premises;

·

visit work places and other premises where products are put into service and used; iii)

·

organize random checks; and iv)

·

take samples of products for examination and testing.

If a product is found to be noncompliant, corrective action will depend on and be appropriate to the level of noncompliance. Others responsible for the noncompliance of the product will be held accountable as well. Penalties, which may include imprisonment, are determined by national law.

U.S. – U.S–Laboratory Developed Test

A laboratory-developed test, or LDT, is a type of in-vitro diagnostic test that is designed, manufactured and used within a single laboratory. LDTs can be single or multianalyte tests used to help diagnose a patient’s state of health. LDTs cannot be used directly for disease screening, as the FDA would regulate this.

The FDA, while it always has claimed the power to regulate LDTs, historically has not enforced the more stringent premarket review and other applicable FDA requirements for many LDTs, especially the relatively simple lab tests that are available on a limited basis. FDA refers to its prior decision to not overtly regulate LDTs as involving its exercise of “enforcement discretion.”  In the absence of the FDA actively regulating LDTs, the primary federal agency exercising control over LDTs has been the Centers for Medicare & Medicaid Services, or the CMS, under the Clinical Laboratory Improvement Amendments, or CLIA. A CLIA certified laboratory is required to determine, validate and submit performance characteristics on around 50 known and 50 unknown samples including:

·

Accuracy;

·

Precision;

·

Analytical sensitivity;

·

Analytical specificity to include interfering substances;

·

Reportable range of test results for the test system;

·

Reference intervals (normal values); and

·

Any other performance characteristic required for test performance.

On July 31, 2014 the FDA notified Congress of the Agency’s intent to issue a draft oversight framework for LDTs based on risk to patients rather than whether a conventional manufacturer or a single laboratory made them. The FDA issued draft guidance on October 3, 2014 regarding its oversight of LDTs which was subject to public comment until February 2, 2015. This oversight includes pre-market review for higher-risk LDTs although the framework would be phased in over many years. There is uncertainty regarding the impact and even the legal status of the FDA’s decision with challenges expected in the US courts. The initial focus for the FDA is on high-risk test categories which includes definitive diagnosis in the absence of a confirmatory technique. Within a CLIA lab, specific claims for use of the Nucleosomics^® technology will therefore be limited, for example, to adjunctive diagnostics, such as identification of circulating blood nucleosomes associated with colorectal cancer. Confirmation of diagnosis will be provided by colonoscopy as with the fecal test.

We do not intend to establish a CLIA laboratory in the United States due to the costs and time frame associated with this. Pending completion of our review of the regulatory environment in the United States, including the effect of the Draft Guidance, we aim initially to enter the United States market by identifying a licensing partner for the Nucleosomics^® technology for establishment of an LDT for adjunctive diagnostics to aid in colorectal cancer diagnosis.

United States–FDA Approval

The Company’sOur diagnostic products are designated as “medical devices” by the FDA. Among other things, the FDA regulates the research, testing, manufacturing, safety, labeling, storage, recordkeeping, pre-market clearance or approval, marketing and promotion, and sales and distribution of medical devices in the U.S.United States to ensure that medical devices distributed domestically are safe and effective for their intended uses. In addition, the FDA regulates the export of medical devices manufactured in the U.S.United States to international markets. We estimate the cost of obtaining FDA approval to be approximately $825,000 USD$5 million per product. FDA approval is more expensive and will likely take at least twice as long as CE Marking in Europe.

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Unless an exemption applies, each medical device that we wish to market in the U.S.United States must first receive either clearance of a 510(k) pre-market notification or approval of a Product Market Application (“PMA”)Approval, or PMA, from the FDA. The FDA’s 510(k) clearance process usually takes from three to twelve months, but it can take significantly longer and clearance is never guaranteed. The process of obtaining PMA approval is much more costly, lengthy and uncertain. It generally takes from one to three years or even longer and approval is not guaranteed. The FDA decides whether a device must undergo either the 510(k) clearance or PMA approval process based upon statutory criteria. These criteria include the level of risk that the agency determines is associated with the device and a determination of whether the product is a type of device that is similar to devices that are already legally marketed. Devices deemed to pose relatively less risk are placed in either Class I or II. Class III devices are those devices which are deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device. In the U.S.,United States, cancer diagnostics usually are considered Class III products, the highest classification (in Europe, cancer diagnostics are not in the high classification group except for home use). As such, most of the Company’sour future products will likelymay have to undergo the full PMA process of the FDA.

A clinical trial may be required in support of a 510(k) submission and is generally required for a PMA application. These trials generally require an effective Investigational Device Exemption, (“IDE”),or IDE, from the FDA for a specified number of patients, unless the product is exempt from IDE requirements or deemed a non-significant risk device eligible for more abbreviated IDE requirements. The IDE application must be supported by appropriate data, such as animal and laboratory testing results. Clinical trials may begin 30 days after the submission of the IDE application unless the FDA or the appropriate institutional review boards at the clinical trial sites place the trial on clinical hold.

Once the application and approval process is complete and the product is placed on the clinical diagnostics market, regardless of the classification or pre-market pathway, it remains subject to significant regulatory requirements. The FDA may impose limitations or restrictions on the uses and indications for which the product may be labeled and promoted. Medical devices may only be marketed for the uses and indications for which they are cleared or approved. FDA regulations prohibit a manufacturer from promoting a device for an unapproved or “off-label” use. Manufacturers that sell products to laboratories for research or investigational use in the collection of research data are similarly prohibited from promoting such products for clinical or diagnostic tests.

Further, our future manufacturing processes and those of our future suppliers will be required to comply with the applicable portions of the FDA’s Quality Systems Regulations, which cover the methods and documentation of the design, testing, production, processes, controls, quality assurance, labeling, packaging and shipping of our intended products. Domestic facility records and manufacturing processes are subject to periodic unscheduled inspections by the FDA. The FDA also may inspect foreign facilities that export products to the U.S.United States.

The FDA has broad regulatory and enforcement powers. If the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions ranging from public warning letters, fines, injunctions, consent decrees and civil penalties to suspension or delayed issuance of approvals, seizure or recall of our future products, total or partial shutdown of production, withdrawal of approvals or clearances already granted, and criminal prosecution. The FDA can also require us to repair, replace or refund the cost of products that we manufactured or distributed. Furthermore, the regulation and enforcement of diagnostics and equipment by the FDA is an evolving area that is subject to change. While we believe that we are and will continue to be in compliance with the current regulatory requirements and policies of the FDA, the FDA may impose more rigorous regulations or policies that may expose us to enforcement actions or require a change in our business practices. If any of these events were to occur, it could materially adversely affect us.

Product Development and Plan of Operations

NuQ^® Panel Tests:   Assays (Cancer and Other Conditions):

·

Research Use Only Market

o§

The NuQ^® panel suite of testsassays has been released for the RUO market.

·

In-Vitro Diagnostics Market

o§

CE Marking (Europe):A pilot NuQ^® panel of 3 testsassays underwent external third party retrospective clinical validations during 2012 which took approximately nine (9) months to completecomplete. A larger NuQ^TM® panel of tests is expected to undergoassays commenced large scale retrospective clinical validations in 2013 which will continue during 2013.2015. Once the retrospective validations are completed, the tests will be submitted for CE Mark approval. We estimate the cost of obtaining CE Marking will be approximately $500,000 USD.$500,000.

19

o

§

FDA Approval (U.S.)(United States): FDA approval is expected to require longer large scale prospective clinical validation studies and is expected to commence in 20132015 and be completed in 2015.2017. When completed, the data will be submitted to the FDA for U.S.United States market approval. We estimate the cost of obtaining FDA approval will be approximately $825,000 USD.$5 million.

The CompanyWe completed initial external testing on a variety of cancers in 20122012-2013 based on the Company’s NuQour Nucleosomics^TM® technology. Cancers were selected by medical need and commercial value and large scale retrospective (CE Mark) and prospective (FDA) clinical validation studies for the cancers identified as most promising in the 2012 studies will commencecommenced in 2013. AWe expect to produce a rolling pipeline of products for different types of cancers is expected to be produced over the next three (3) to five (5) years.

HyperGenomics^® Test:

·

Research Use Only Market

o

First revenue from HyperGenomics^® profiling was achieved in 2012. A simplified test method was developed. Prototype research kits are expected to be completed in 2013, followed by beta-testing which shall take approximately six (6) months at a cost approximately $50,000 USD. HyperGenomics^® kits will used to offer contract research services by Volition (2013) and through licensing to selected partners (2014) Research kits be launched into the RUO market in Europe and in the U.S. by 2014.  The HyperGenomics^® test is too early in its development for the Company to accurately determinate the manufacturing costs and sale price of the test.  

·

In-Vitro Diagnostics Market

A protocol for blood testing was developed in 2012.  The Company expects to work on the clinical proof of concept for personalized medicine applications and validation for the HyperGenomics^® test in 2013.  The timeframe for launch of the first HyperGenomics^® test into the IVD market will depend largely on the scale of clinical trials required by regulators in Europe and the U.S.

NuQ^®-EndoEndometriosis Test:  

·

Research Use Only Market

o

The Company does not intend to bring the NuQ^®-Endo test to the RUO market and instead will focus its efforts on bringing it to the IVD market.

·

In-Vitro Diagnostics Market

o

Currently, the NuQ^®-Endo test is undergoing hypothesis-testing and clinical proof of concept work.  The Company expects to continue with validations for the NuQ^®-Endo test in 2013.  Once the proof of concepts and validations are completed, the Company will then perform a large scale prospective clinical trial which shall take approximately twelve (12) months to complete and will cost approximately $50,000 USD.  If the Company is successful in developing a reliable test, we hope to partner with large pharmaceutical companies to bring these tests to the IVD market in Europe and the U.S.  The NuQ^®-Endo is too early in its development for the Company to accurately determinate the manufacturing costs and sale price of the test.  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.

NuQ^® Clinical Diagnostic Products:

·

Centralized Laboratory Market

o§

License of NuQNucleosomics^® technology to a global diagnostics company: The Company We may license our NuQNucleosomics^® technology on a non-exclusive basis to a global diagnostics company. The approximate licensing fees have not yet been determined. As of the date of this Report, the Company haswe have not entered into any discussions or negotiationsagreements with diagnostic companies or established an anticipated timeframe for licensing our NuQNucleosomics^® technology.

o§

Sell manual and/or semi-manual ELISA plates to centralized laboratories: The CompanyWe may sell manual and/or semi-automated 96 well ELISA plates for use by centralized laboratories. The approximate manufacturing costs or sales price have not yet been determined. As of the date of this Report, the Company hasprospectus, we have not entered into any discussions or negotiations with diagnostic companies or established an anticipated timeframe regarding the sale of ELISA plates.

o§

Point-of-Care Devices:  The Company expects We intend to enter the point-of-care clinical market in Europe in 20152017 and in the U.S.United States in 2016.2018. The approximate manufacturing costs or sales price per device have not yet been determined. As of the date of this Report, the Company haswe have not entered into any discussions or negotiations regarding the manufacture or sale of these devices.

o§

Disposable Home Use orTests for Doctor’s Office Tests:  The Company intendsor Home Use: We intend to contract with a specialist company to adapt the NuQ^® tests to the doctor’s office or home use system and to contract with their manufacture.a manufacturer for the production of these tests. The sale of these tests will initially be for professional use only (doctors) and will likely be released at a later time for non-professional home use. The approximate manufacturing costs or sales price per test have not yet been determined. As of the date of this Report, the Company haswe have not entered into any discussions or negotiations with a specialist company or manufacturer. The Company doesWe do not yet have an estimated timeframe for the manufacture or sale of these tests.

If we do not have enough funds to fully implement our business plan, we will be forced to scale back our plan of operations and our business activities, increase our anticipated timeframes to complete each milestone or seek additional funding. In the event that additional financing is delayed, the Companywe will prioritize the maintenance of its research and development personnel and facilities, primarily in Belgium, and the maintenance of itsour patent rights. However the development of the current pipeline of intended products for the RUO market would be delayed, as would clinical validation studies and regulatory approval processes for the purpose of bringing products to the IVD market. In the event of an ongoing lack of financing, the Companywe may be obliged to discontinue operations, which will adversely affect the value of its common stock.operations.

Sales and Marketing Strategy

The first usesales of our future NuQ^® products will bewere for the RUO market, as the RUO market does not require government approval, as opposedcompared to the clinical IVD market. We believe that by sellinghave however decided to focus our intendedefforts on launching our first products in the RUOclinical market we will drive awarenessin the EU given our very encouraging results in Denmark, the much larger potential of the IVD market and our limited resources, which require us to focus our efforts. Pending completion of our Company and our intended products whichreview of the regulatory environment in turn, will leadthe United States, including the effect of the Draft Guidance, we aim to future salesenter the United States market by adopting a licensing model to a CLIA laboratory in both the United States. Our RUO and IVD clinical markets. The Company’s products are available for sale to researchers via the Company’sour product website,http://www.nucleosomics.com. Initially, the Company will provide its products to carefully chosen opinion leaders to provide further validation www.nucleosomics.comand product feedback.through a contracted distributor.

20

The Company will use the following methodsWe intend to generate revenues from its intended products:

·

Direct Sales:  As the Company desires to launch its intended products into both theprimarily sell our RUO and IVD markets as quickly as possible, direct sales will be the first path to market the future suite of NuQ^® products as well as all of the Company’s other future products when they are first available for sale.  We hope to achieve initial sales through strong existing contacts and a dedicated product website.  As of the date of this Report, the Company has not begun direct sales or entered into any sales agreements for any of its intended products.  The Company hired a Sales and Marketing Director on September 1, 2012, whose remit is the direct sales of the Company’s first research products.

·

Product Sales Partners:  If the Company is able to sell its intended products, the Company will strive to carry out the majority of its sales of diagnostic and research products through contracted sales and marketing partners. This will be organized by territory, by region and end user, e.g. clinical vs. research.   We estimate such partners will take approximately 30% to 40% of the sales prices of any products sold through these channels.  While initial discussions have been commenced, the Company has not finalized any formal partnerships.  

·

Distribution Agreements:  Distributiondistribution agreements will be used primarily in those markets and territories where the Company haswe have no real prospect of obtaining traction alone or where the entry barriers are high. The Company plansWe plan to enter into tightly drawn distribution agreements outlining the territory and sectors to be covered. ControlWe will be maintained by the Companymaintain control through strict oversight and by centralized production centers that will provide supplies to distributors. We estimate such distributors will take approximately 30%30-40% of the sales prices of any products sold through these channels. As of the date of this Report, the Company has notWe have entered into anythree distribution agreements. The first wholesale order of these RUO products commenced in June 2014.

The Company’sOur future products will require several dynamic and evolving sales models tailored to different worldwide markets, users and products. The Company has decided to focus itsPending completion of our review of the regulatory environment in the United States, including the effect of the Draft Guidance, we will combine a licensing and sales strategy focused on the initial RUO market in 2013 and develop a flexible strategy for its future IVD products through 2015. We intend to license NuQ^® tests for LDT use in the later part of 2013.  We hopeUnited States and to progressively grow to largesales volumes of tests soldafter CE marking in Europe and FDA approval in the United States with sales to centralized laboratories and eventually reach the mass diagnostics testing market. The exact nature of the ideal sales strategy will evolve as the Company continueswe continue to develop itsour intended products and seek entry into the RUO and IVD markets.

Government Regulations

The health care industry, and thus our business, is subject to extensive federal, state, local and foreign regulation. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of subjective interpretations. In addition, these laws and their interpretations are subject to change.

Both United States federal and state governmental agencies continue to subject the health care industry to intense regulatory scrutiny, including heightened civil and criminal enforcement efforts. As indicated by work plans and reports issued by these agencies, the federal government will continue to scrutinize, among other things, the marketing, labeling, promotion, manufacturing and export of diagnostic health care products. Our diagnostic products fall within the medical device category and are subject to FDA clearance or approval in the United States. The FDA has historically exercised enforcement discretion over tests developed by and used within single laboratories, known as LDTs. The CMS has regulated laboratories, including those that develop LDTs, under the Clinical Laboratory Improvement Amendments (42 U.S.C. 263a) since 1988. Reagents used for the production of LDTs (Analyte Specific Reagents) are subject to less overt FDA regulation and can be sold to clinical laboratories to perform high complexity testing provided such tests are developed are labeled in accordance with FDA requirements, including a statement that their analytical and performance characteristics have not been established. We believe that Analyte Specific Reagents that we have developed, including antibodies with specificity for histone modifications and histone variants, may be sold to clinical reference laboratories in the United States and do not currently require FDA approval or clearance. However, on October 3, 2014, the FDA issued draft guidance implementing a new framework for the regulation of LDTs, which could include pre-market review. As these regulations are not yet final, we cannot be sure that the FDA will not require that one or more of our reagents would require premarket approval. Further, we cannot guarantee that the FDA would consider licensing of our intellectual property as labeling, which would subject the Analyte Specific Reagents we supply to FDA regulation including, but not limited to, PMA.

The FDA has recently proposed a new regulatory oversight framework for LDTs which, if adopted as proposed, will continue the FDA’s current enforcement discretion for traditional LDTs that are:

·

designed, manufactured and used within a single laboratory;

·

manufactured and used by a health care facility laboratory (such as one located in a hospital or clinic) for a patient that is being diagnosed and/or treated at that same health care facility or within the facility’s healthcare system;

·

comprised only of components and instruments that are legally marketed for clinical use; and

·

interpreted by qualified laboratory professionals without the use of automated instrumentation or software for interpretation.

The proposals were subject to public comment until February 2, 2015. Changes in the FDA position could negatively affect our operations.

Please refer to the section above titled “Government Approval” for additional information regarding the draft guidance.

The federal government also has increased funding in recent years to fight health care fraud, and various agencies, such as the U.S.United States Department of Justice, the Office of Inspector General of the Department of Health and Human Services, or OIG, and state Medicaid fraud control units, are coordinating their enforcement efforts.

21

In Europe, medical devices are regulated by self-certification through the CE mark system. Under the system, developers and manufacturers must operate a Quality System and validate medical devices in a limited clinical trial to demonstrate the manufacturer has met analytical and clinical performance criteria. Volition is implementing an International Organization for Standardization standard - ISO 13485 - quality management system for the design and manufacture of medical devices. ISO 13485 addresses managerial awareness of regulatory requirements, control systems, inspection and traceability, device design, risk and performance criteria as well as verification for corrective and preventative measures for device failure. Medical device companies such as ours are subject to pre-market compliance assessments from Notified Bodies, a certification organization which the national authority (the competent authority) of a European member state designates to carry out one or more of the conformity assessment procedures. ISO 13485 certification establishes conformity to specific European Union directives related to medical devices and allows CE marking and sale of the device.

We will also be required to comply with numerous other federal, state, and local laws relating to matters such as safe working conditions, industrial safety, and labor laws. We may incur significant costs to comply with such laws and regulations in the future, and lack of compliance could have material adverse effects on our operations.

We believe that we have structured our business operations to comply with applicable legal requirements. However, it is possible that governmental entities or other third parties could interpret these laws differently and assert otherwise.

Please refer to the section above titled “Government Approval” for additional information.

Competition

We believe that our main competitor in the blood-based diagnostic market is Epigenomics AG. Epigenomics has European approval for its methylated DNA based PCR tests in colon cancer (Epi proColon^®) and lung cancer (Epi proLung). In colon cancer, our main target market, we face potential competition from alternative procedures including flexible sigmoidoscopy, colonoscopy and virtual colonoscopy as well as traditional tests such as the guiac and immunochemical FIT Tests. Exact Sciences Corporation has recently received FDA approval and reimbursement approval for its stool-based DNA screening test. We anticipate facing competition primarily from large healthcare, pharmaceutical and diagnostic companies such Epigenomics AG and Exact Sciences Corporation, as well as others such as Abbott Laboratories Inc., Cepheid Inc., Philips, GE Healthcare, Siemens, Gen-Probe Incorporated, MDxHealth SA, EpiGenomics AG, Roche Diagnostics and Sequenom, Inc.

We hope that our future products will have a competitive edge compared to those offered by competitors on the basis that our tests are being developed to be accurate, cost-effective and attractive from a government reimbursement perspective, easy to use, non-invasive, technologically advanced, compatible with ELISA systems, based on strong intellectual property and to be used for mass screenings.

Many of our anticipated competitors have substantially greater financial, technical, and other resources and larger, more established marketing, sales and distribution systems than we will have. Many of our future competitors also offer broad product lines outside of the diagnostic testing market and have brand recognition. Moreover, our future competitors may make rapid technological developments that may result in our intended technologies and products becoming obsolete before we are able to enter the market, recover the expenses incurred to develop them or generate significant revenue. Our success will depend, in part, on our ability to develop our intended products in a timely manner, keep our future products current with advancing technologies, achieve market acceptance of our future products, gain name recognition and a positive reputation in the healthcare industry, and establish successful marketing, sales and distribution efforts.

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WHERE YOU CAN GET ADDITIONAL INFORMATION

We file annual, quarterly and current reports, proxy statements and other information with the SEC.  You may read and copy our reports or other filings made with the SEC at the SEC’s Public Reference Room, located at 100 F Street, N.E., Washington, DC 20549.  You can obtain information on the operations of the Public Reference Room by calling the SEC at 1-800-SEC-0330. You can also access these reports and other filings electronically on the SEC’s web site,www.sec.gov.

ITEM 1A. RISK FACTORS

We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this item.

ITEM 1B. UNRESOLVED STAFF COMMENTS

None.

ITEM 2.

PROPERTIES

Our principal executive office is located at 1 Scotts Road, #24-05 Shaw Centre, Singapore 228208.  We currently rent this space for approximately $1,500USD$1,500 a month.  Currently, this space is sufficient to meet our needs, however, once we expand our business to a significant degree, we will have to find a larger space. We do not foresee any significant difficulties in obtaining any required additional space.   We do not currently own any real estate.

Belgian Volition rented laboratory and office space at Facultés Universitaires Notre-Dame de la Paix located at 61 rue de Bruxelles, B-5000, Namur, Belgium for approximately $1,028 USD (€778 EUR) per month pursuant to a lease entered into with the University on January 31, 2011 for a leasing term of one year.  On February 1, 2012, Belgian Volition entered into an amended leasing agreement with the University, extending the original lease for an additional three months.  On January 26, 2012 Belgian Volition entered into a new lease agreement to maintain its existing laboratory space only at the University for $1,322 USD (€1,000 EUR) per month commencing April 1, 2012 for a leasing term of one year, which period may be extended by mutual agreement.

On February 29, 2012, Belgian Volition entered into a lease agreement for larger laboratory and office space at 20A Rue de Séminaire, 5000, Namur, Belgium for approximately $5,065 USD (€3,833 EUR)$5,091 per month commencing April 1, 2012 for a leasing term of two years and eight months. Additionally, Belgian Volition shall pay $1,982 USD (€1,500) EUR$1,992 per month as a provision against expenses.   Commencing December 1, 2014 the lease was extended for an additional leasing term of two years at approximately $5,590 per month. Additionally, Belgian Volition shall pay $970 per month as a provision against expenses.

ITEM 3.

LEGAL PROCEEDINGS

In the ordinary course of business, we may be subject to claims, counter claims, suits and other litigation of the type that generally arise from the conduct of our business. We knoware not aware of no material, existingany threatened or pending legal proceedings against our Company, nor arelitigation that we involved as a plaintiff in any material proceeding or pending litigation.  There are no proceedings in which our director, officer or any affiliates, or any registered or beneficial shareholder, is an adverse party or hasexpect will have a material interest adverse toeffect on our interest.business operations, financial condition or results of operations.

ITEM 4.

MINE SAFETY DISCLOSURES

Not Applicable.

PART II

ITEM 5.

MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Common Stock

Our common stock is currently quoted on the OTC Bulletin Board. Our common stock has beenwas quoted on the OTC Bulletin Board sincefrom April 12, 2007 under the symbol “SNDC.OB.”  Effective October 11, 2011 our symbol was changed to “VNRX.OB” to reflect the Company’s name change.  Because we arewere quoted on the OTC Bulletin Board, our securities may behave been less liquid, receivereceived less coverage by security analysts and news media, and generategenerated lower prices than might otherwise be obtained if they were listed on a national securities exchange. On February 6, 2015, we up-listed our common stock onto the NYSE MKT.

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The following table sets forth the high and low bid prices for our common stock per quarter as reported by the OTCBB for 20122014 and 20112013 based on our fiscal year end December 31. These prices represent quotations between dealers without adjustment for retail mark-up, markdown or commission and may not represent actual transactions.