Following the state's approval, the ClonoSEQ Assay will be available in all 50 states.
Adaptive Biotechnologies’ next-generation sequencing test for the detection and monitoring of minimal residual disease (MRD) in patients with certain blood cancers will now have a presence in all 50 states following approval from the State of New York Clinical Laboratory Evaluation Program (CLEP).
The clonoSEQ Assay is the first and only test authorized by the FDA for MRD assessment in bone marrow samples from patients with B-cell acute lymphoblastic leukemia (ALL) and multiple myeloma. The FDA granted De Novo designation for the test in October, with former FDA Commissioner Scott Gottlieb, MD, calling the approval “an important step forward for patients suffering from ALL and multiple myeloma.” The test is covered by Medicare and is increasingly being covered by private payers in alignment with its FDA label.
While the device was granted FDA approval, New York follows its own approval process for diagnostics through CLEP. As a result of last week’s approval, patients in New York with B-cell cancers, including ALL and multiple myeloma, will now have access to clonoSEQ to assess disease burden.
“New York State CLEP approval for clonoSEQ means patients in New York can now work with their cancer care team to incorporate clonoSEQ into their treatment regimen to accurately and reliably assess and monitor their disease over time, using multiple sample types, including blood samples,” Chad Robbins, chief executive officer and cofounder of Adaptive Biotechnologies, said in a statement.
Testing for MRD is increasingly being used among patients with cancer, particularly blood cancers, because of the association between deep MRD negativity and better patient outcomes, as well as its use in helping providers made decisions regarding treatment.
“This rigorous approval also supports our ongoing work to expand access to patients and our pursuit of FDA authorization for new indications for clonoSEQ in other lymphoid cancers and sample types,” said Robbins.