Kelsy Ketchum

The agency had originally planned to delete unspecified diagnosis codes for certain cancer tests covered under a national coverage decision.

The LCD covers tests that are FDA approved or cleared, have published analytical validity evidence, or are certified by a third party to be aligned with NYSDOH's criteria. 

The firm has submitted data to the Centers for Medicare and Medicaid Services' MolDx program to pursue reimbursement.

The firm's RaDaR test looks at 48 known mutations for MRD monitoring and has received breakthrough device designation from the FDA.

The molecular residual disease test from Natera was first made available to biopharmaceutical customers and clinicians across China in June.

SEngine's PARIS test combines high-throughput drug screening of live, patient-derived tumor cells with DNA sequencing and data analysis.

The Indian liquid biopsy company recently launched its Trublood tests for prostate cancer and pan-cancer detection using circulating tumor cells.

The digital pathology firm is working to further develop its diagnostic capabilities and broaden its menu of algorithms for different diseases.

The proposed change would delete payable cancer codes if they contain the word "unspecified" even if the word is included in a code that doesn't impact coverage.

The test uses prognostic markers to group women based on their risk of 10-year recurrence of ductal carcinoma in situ.