multiple myeloma

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

In granting de novo premarket authorization to ClonoSeq, the agency established its regulatory expectations for similar tests.

Sebia and Janssen Biotech collaborated on the development of the test, which is for assessing patients treated with Darzalex. 

The company recently reached separate deals with Innova Biosciences and Skannex to make it the preferred supplier and partner for lateral flow development and manufacturing with those firms.

Microgenics, Astute Medical, and Siemens were among the firms whose tests and/or systems were cleared by the FDA for marketing last month.

The test may mitigate potential interference during immunofixation tests that measure a patient’s response to a multiple myeloma therapy.