New York Approves NGS-Based Test to Detect, Monitor MRD in Certain Blood Cancers
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
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
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
“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.
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