NEW YORK – Adaptive Biotechnologies said Tuesday that its ClonoSeq assay has received expanded coverage through Medicare administrative contractor Palmetto to include single time point testing to monitor for mantle cell lymphoma (MCL) recurrence.
The expanded coverage adds to the existing Medicare payment structure for ClonoSeq, which provides coverage for a bundle of tests to assess patient therapy response. Under the expanded coverage decision, patients who have completed treatment are now covered to receive ClonoSeq testing every six months for up to five years during treatment-free remission and annual testing thereafter until disease recurrence is detected.
MCL is the first ClonoSeq indication to receive this determination, and pricing will be consistent with the recently updated Clinical Laboratory Fee Schedule rate of $2,007 per ClonoSeq test, Adaptive said.
"Securing coverage for ClonoSeq use in the MCL surveillance setting is a significant win for MCL patients," Ben Eckert, senior VP of market access at Adaptive Biotechnologies, said in a statement. "This coverage expansion enables clinicians to more effectively monitor and manage these patients who are at risk of relapse. We believe this determination underscores the clinical utility of ClonoSeq testing and establishes a framework for potential expanded coverage of surveillance testing in other Medicare-covered ClonoSeq indications."
In a research note, BTIG analyst Mark Massaro noted that the new coverage is "a big potential step up from its current four-pack test episodic structure." While MCL is a smaller indication for the company, he further noted, "we believe today's expanded Medicare coverage sets up a path for Adaptive to obtain expanded surveillance testing in its other core heme indications." BTIG also reiterated its Buy rating on the company's stock.
ClonoSeq is a sequencing-based immune system analysis platform that can identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. Testing for patients with MCL is currently available for clinical use as a laboratory-developed test performed at Adaptive's CLIA-certified lab in Seattle. ClonoSeq testing in MCL has also been previously approved by New York state's Clinical Laboratory Evaluation Program.
In Tuesday afternoon trading on the Nasdaq, shares of Adaptive were down nearly 3 percent at $7.49.