Invitae Announces Sensitivity and Workflow Enhancements to its MRD Test

11-7-23 (by: Scott Gleason) Invitae has announced the launch of an enhanced chemistry version of its Invitae Personalized Cancer Monitoring platform. The technology is designed to detect circulating tumor DNA (ctDNA) as a biomarker for solid tumor malignancies in order to clinically assess patient response, disease progression, prognostic stratification, and the early detection of residual disease. The assay enhacements recently received Clinical Laboratory Improvement Amendments (CLIA) approval and has a sensitivity rate of over 99% for detecting ctDNA, even at variant allele frequencies as low as 0.005%. The enhanced assay offers improvements over its previous MRD test in several aspects. It features a lower mass input limit while maintaining the same high sensitivity, allowing for testing on some previously rejected samples. Furthermore, the enhanced chemistry is designed to be automation-friendly, laying the groundwork for scalability and accommodating future growth. In March the company announced that its Personalized Cancer Monitoring assay had obtained its first commercial coverage in all solid tumors by Blue Shield of California. The company launched the test in March of 2022.

Bob Daber, Ph.D., chief scientific officer of Invitae, said, “This focused launch and enhanced chemistry will enable biopharma partners to detect recurring disease early. This will potentially help set MRD as a standard practice in clinical studies and increase the velocity of drug development. Our vision is that insights gained from Invitae Personalized Cancer Monitoring will lead to research breakthroughs that positively influence patient journeys.”