NEW YORK – Molecular diagnostics firm EntroGen announced Monday that its CRCdx RAS Mutation Detection Kit has received coverage from the US Centers for Medicare and Medicaid Services' MolDx program.
The real-time PCR-based companion diagnostic test identifies colorectal cancer patients eligible for treatment with Amgen's Vectibix (panitumumab) based on the absence of KRAS and NRAS mutations. The assay received premarket approval from the US Food and Drug Administration in 2023.
The test is covered under Medicare administrative contractor Palmetto GBA's local coverage determination for molecular diagnostic tests.
"CMS reimbursement for CRCdx represents more than just a policy decision — it's a validation of the test's clinical value and impact," EntroGen CEO Matthew Minkovsky said in a statement. "With CMS reimbursement, we expect CRCdx to reach even more laboratories and patients. This reinforces our commitment to making precision medicine accessible and affordable."