Inivata's RaDar Assay has gained CE certification, demonstrating that it complies with the European In-Vitro Diagnostics Directive.
Fremont, CA: "Receiving CE marking for RaDaR is a testament to the quality of our technology and the robustness of our processes." states Clive Morris, President of Inivata. Inivata, a leader in liquid biopsy, has gained CE certification for its RaDar assay for the detection of molecular residual disease (MRD) and recurrence, demonstrating that it meets the requirements of the European In-Vitro Diagnostics Directive. Inivata has also applied for reimbursement of RaDaR for clinical testing through the MolDX program in the United States.
Both milestones have been met, paving the way for RaDaR to be commercialized in a clinical context, both in conjunction with biopharma partners and other collaborators, as well as through Inivata's own clinical development program. In several significant areas, notably the United Kingdom and the European Union, medical devices require the CE mark for use in clinical applications; hence the assay's attainment of the designation encourages more clinical use.
RaDaR is an innovative, highly sensitive personalized liquid biopsy assay that uses a simple blood draw to track a set of up to 48 tumor-specific variants in a patient, allowing for the detection of residual disease after curative intent or definitive treatment, as well as early detection of relapse. RaDaR has shown that it can identify circulating cancer DNA with a high degree of sensitivity and specificity. Analytical validation findings previously published at AACR 2020 showed 95 percent sensitivity and 100 percent specificity at circulating tumor DNA concentration levels as low as 0.0011 percent variant allele frequency, or 11 parts per million.
Mark Mallon, CEO of NeoGenomics Laboratories, states, "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."