Inivata Announces Clinical Collaboration with Princess Margaret Cancer Center for the
use of its Liquid Biopsy Assays
Two clinical studies including interventional RaDaR™ study
Research Triangle Park, NC, USA and Cambridge, UK, 19 October 2021 -- Inivata, a leader in liquid biopsy, today announced a clinical collaboration with the Princess Margaret Cancer Center in Toronto, Canada, for the use of Inivata's liquid biopsy assays, InVisionFirst®-Lung and RaDaR™ in two separate studies.
The Accelerating Lung Cancer Diagnosis through Liquid Biopsy, ACCELERATE, study plans to compare time to treatment initiation in advanced non-small cell lung cancer (NSCLC) patients who have had a liquid biopsy, versus those patients referred in the previous 12 months who were treated based on tissue profiling. This prospective, single-arm study will use Inivata's InVisionFirst-Lung, a ctDNA next-generation sequencing (NGS) liquid biopsy, testing 37 genes relevant to the care of patients with advanced NSCLC and will assess the utility of blood-based NGS to accelerate time to treatment in patients awaiting their diagnostic tissue biopsy and molecular profiling. Patient recruitment has already started, with the aim to enroll a total of 150 patients with advanced NSCLC over the next 12 months.
The second study, ctDNA Lung, will use Inivata's RaDaR assay for ctDNA detection of minimal residual disease (MRD) to identify patients for curative therapy after lung cancer resection and will be split into two phases. The first phase, DETECT, will screen 360 early-stage lung cancer patients to assess the rate of pre- and post-operative ctDNA levels using RaDaR. Of the 360 patients, 66 participants with ctDNA detected at 3-6 weeks post-operatively will be referred to the second phase for a randomized controlled trial, RCT, investigating the benefit of intensified adjuvant treatment with chemo-immunotherapy.
Clive Morris, President of Inivata, said: "Inivata is committed to building a robust body of evidence to support the use of its innovative liquid biopsy technologies and we are delighted to be collaborating with the Princess Margaret Cancer Center, which is one of the largest and most prestigious cancer centers in the world. The ctDNA lung trial is another important step in demonstrating the potential of our exceptionally sensitive RaDaR assay in the early detection of residual disease and informing treatment decisions which lead to better outcomes for patients."
Dr. Natasha Leighl, Lung Site Lead, Medical Oncology, Princess Margaret Cancer Center, said: "Liquid biopsy technologies have the potential to transform cancer treatment, getting patients to the right treatment faster and increasing the chances of a cure. We look forward to working with Inivata on these important studies."
Inivata is the liquid biopsy-focused subsidiary of the NeoGenomics, Inc (NASDAQ:NEO) Group. Inivata's InVision® liquid biopsy platform unlocks essential genomic information from a simple blood draw to guide and personalize cancer treatment, monitor response and detect relapse. Inivata's technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge. The personalized RaDaR™ assay allows the highly sensitive detection of residual disease and recurrence and has been granted Breakthrough Device Designation by the US FDA. The commercially available InVisionFirst®-Lung test offers best-in-class sensitivity and turnaround and provides molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata is partnering with pharmaceutical, biotechnology companies and commercial partners in a range of early and late-stage cancer development programs across a range of cancer types. Inivata has a CLIA certified, CAP accredited laboratory in Research Triangle Park, NC and R&D laboratories in Cambridge, UK.
RaDaR is Inivata's assay for the detection of molecular residual disease (MRD) and recurrence. Built on Inivata's proven InVision® liquid biopsy platform technology, RaDaR is a highly sensitive personalized assay that tracks a set of up to 48 tumor-specific variants in a patient using a liquid biopsy, allowing both detection of residual disease following curative intent or definitive treatment, and early detection of relapse. RaDaR has been granted Breakthrough Device Designation by the US FDA.
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