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MolDx Finalizes Expanded Coverage for Liquid Biopsies

NEW YORK – Wisconsin Physicians Service Insurance Corporation released its final coverage policy on Thursday for the Guardant360 liquid biopsy assay.

The policy stipulates that WPSIC will only cover the Guardant360 assay if the patient has a recurrent, relapsed, refractory, metastatic, or advanced solid tumor that didn't originate from the central nervous system. The Medicare contractor further noted that patients who have an NTRK mutation and meet all the indications in the US Food and Drug Administration-approved label for larotrectinib (Bayer's Vitrakvi) can be considered to have advanced cancer. The patient can't have been previously tested with Guardant360 for the same primary cancer, and the patient must have decided to seek further cancer treatment.

If the patient has decided to seek further treatment, the patient has to be a candidate for treatment with a drug that is either approved by the FDA or has a National Comprehensive Cancer Network (NCCN) 1 or NCCN 2A recommendation for the cancer; the FDA-approved indication or NCCN recommendation must require the presence or absence of a genetic biomarker gauged by the Guardant360 assay; and tissue-based comprehensive genomic profiling must not be feasible.

Other liquid biopsies will be covered for the same indications if they display similar performance in their intended use applications to Guardant360. This coverage determination goes into effect March 15.

WPSIC is a member of the MolDx program, and this determination aligns with Palmetto's final coverage determination, which was released in December. The Palmetto decision goes into effect Feb. 3.

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