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Invitae's PCM Assay for Minimal Residual Disease Detection Nabs Coverage by Blue Shield of California

NEW YORK – Invitae said Monday that Blue Shield of California has updated its policy to cover its Personalized Cancer Monitoring (PCM) assay, a tumor tissue-informed, patient-specific technology to detect minimal residual disease in cancer patients.

The policy, effective March 1, considers the test medically necessary for patients with stages I-IV cancer after surgical intervention for adjuvant or targeted therapy and/or monitoring for relapse or progression. It is the first commercial coverage for the test across solid tumors, Invitae said.

PCM is based on technology developed by ArcherDx, which Invitae acquired in 2020. The company uses tumor tissue sequencing data to develop personalized assays comprising a variable number of genetic alterations that are then used to detect circulating tumor DNA in blood samples.

Rival MRD firm Natera said last week that its Signatera assay, which uses an analogous method, has also gained coverage by Blue Shield of California under the same policy update. Based on its language, the policy could also apply to other tumor-informed MRD products.

The payor's coverage criteria for MRD stipulate that both of two conditions must be met for test reimbursement. First, patients must have had a surgical intervention with curative intent, and physicians must be seeking MRD testing to inform adjuvant or targeted therapy, or monitor for relapse or progression. Second, the frequency of testing must not exceed what is recommended by the National Comprehensive Cancer Network guidelines for RECIST (Response Evaluation Criteria in Solid Tumors) for various specific indications.