Personalis (PSNL) said Wednesday its NeXT personal minimal residual disease test has been approved for expanded coverage by the US Centers for Medicare & Medicaid Services' Molecular Diagnostic Services Program.
The approval is for monitoring treatment response to neoadjuvant therapy in patients diagnosed with Stage II-III triple-negative breast cancer or HER2-positive breast cancer, it said Wednesday.
The coverage decision was backed by clinical evidence from a 227-patient study showing monitoring with NeXT allows accurate tracking of therapy response, outperforming standard clinical metrics, the company said.
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