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.
Currently marketed for research use by Biofluidica, the test's microfluidic channels use specific cancer antibodies to detect capture circulating tumor cells.
The test measures the multiple myeloma marker M protein and could prove more sensitive and less susceptible to interferences than existing assays.
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 new algorithm, called TOPSPIN, complements the company's MMprofiler test. It is considering making TOPSPIN-generated data available to its MMprofiler patients.
The test may mitigate potential interference during immunofixation tests that measure a patient’s response to a multiple myeloma therapy.
The test is designed to replace gel electrophoresis assays currently used for measuring M-proteins, biomarkers for plasma cell diseases such as multiple myeloma.