Palmetto

Following FDA approval last October, Adaptive has now secured Medicare coverage for its NGS-based minimal residual disease assay, ClonoSeq.

The test is a targeted sequencing assay that detects mutations in the blood of non-small cell lung cancer patients to inform treatment selection.

Palmetto proposes to cover the assay for prostate cancer patients who are at very low and low risk of negative outcomes with active surveillance by NCCN guidelines.

The final LCD, which expands Medicare coverage of the firm's ConfirmMDx test to all providers, becomes effective on Sept. 3.

The coverage decision limits the test mainly to patients with advanced lung cancers who haven't been genomically profiled and who can't receive tissue testing.

Under the draft determination, the test would be covered to help assess which treatments to use in patients with advanced prostate cancer.

Piper Jaffray analyst William Quirk said the pricing, which was much higher than expected, will help push CareDx toward profitability.

The final LCD covers AlloSure in renal allograft recipients who have a probability of active renal allograft rejection.

The genomic test is designed to help doctors decide which patients are at low enough risk that they can be more conservatively managed.

The molecular testing firm estimated that more than 70 percent of Medicare patients with prostate cancer will now have coverage for Prolaris.