Inivata Announces RaDaR™ Assay Receives CE Mark and is Submitted for US Reimbursement via the MolDX Program
Research Triangle Park, NC, USA and Cambridge, UK, 11 January 2022 — Inivata, a leader in liquid biopsy, today announced that it has received the CE mark for its RaDaR™ assay for the detection of molecular residual disease (MRD) and recurrence, having met the requirements of the European In-Vitro Diagnostics Directive (98/79/EC). In addition, Inivata has submitted to the MolDX program in the US for the reimbursement of RaDaR for clinical testing.
The achievement of both milestones supports the commercialization of RaDaR in a clinical setting, both in collaboration with biopharma partners and other collaborators, as well as Inivata’s own clinical development program. Medical devices require the CE mark for use in clinical applications in several key territories including the UK and the EU, and receipt of the designation therefore supports increasing clinical use of the assay.
RaDaR is an innovative, highly sensitive personalized liquid biopsy assay that tracks a set of up to 48 tumor specific variants in a patient using a simple blood draw, allowing both the detection of residual disease following curative intent or definitive treatment, and early detection of relapse. RaDaR has demonstrated exceptionally high sensitivity and specificity in detecting circulating cancer DNA. Previously presented analytical validation data at AACR 2020 demonstrated 95% sensitivity and 100% specificity at circulating tumor DNA concentration levels as low as 0.0011% variant allele frequency or 11 parts per million.
Clive Morris, President of Inivata, said: “Receiving CE marking for RaDaR is a testament to the quality of our technology and the robustness of our processes. The certification should strengthen both our ability to support clinical trials in Europe and the future commercialization of the MRD assay. In the US, submitting to the MolDX program for the reimbursement of RaDaR represents our continuing efforts to accelerate access to our vital technology.”
Mark Mallon, CEO of NeoGenomics Laboratories, said: “The achievement of these key milestones reflects the exciting work that is ongoing at Inivata and the quality of its science, as well as instilling further confidence in the RaDaR technology to provide meaningful molecular information to help guide clinical decisions and make clinical trials more efficient. We look forward to seeing continued regulatory progress with RaDaR, supporting its future success in a commercial setting.”
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.
Consilium Strategic Communications
Chris Gardner/Angela Gray/Genevieve Wilson
Alix Floyd (US)
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