clonoSEQ Assay Now Covered by Medicare for Multiple Myeloma and Acute Lymphoblastic Leukemia

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by José Lopes, PhD |

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The clonoSEQ Assay — a test that detects cancer cells present in very small numbers in a patient’s bone marrow — will now be covered by Medicare for patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL).

Palmetto GBA, a Medicare administrative contractor that assesses diagnostic technologies through its MolDX program, established the coverage.

Adaptive Biotechnologies’ clonoSEQ is the only test authorized by the U.S. Food and Drug Administration to detect and monitor minimal residual disease (MRD) in any blood cancer using DNA from a patient’s bone marrow. MRD refers to the small number of residual cancer cells that remain in the body after treatment, which may lead to disease recurrence.

Current myeloma and ALL treatment guidelines recommend MRD testing to determine disease burden over the course of care.

According to Adaptive, clonoSEQ provides accurate, highly sensitive, and standardized identification and quantification of specific DNA sequences in malignant cells. This enables the prediction of patient outcomes, assessment of treatment response over time, monitoring of patients during remission, and detection of relapses. To obtain coverage, the assay had to meet the bar for clinical utility required by Medicare.

The coverage is in line with clonoSEQ’s FDA label. It includes assessments of MRD at multiple time periods during therapy. The article, also posted by Noridian, is effective immediately.

“Availability of sensitive, specific and standardized MRD testing is increasingly crucial to the delivery of optimal patient care in both multiple myeloma and ALL,” Nikhil Munshi, MD, director of basic and correlative science at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, said in a press release.

“Medicare coverage for the clonoSEQ Assay,” Munshi added, “will help ensure that eligible patients across the U.S. have access to a highly advanced option for MRD assessment to support more personalized treatment decisions across their course of care.”

In October 2018, the FDA cleared clonoSEQ under the de novo designation to detect and monitor MRD in patients with multiple myeloma and ALL.

“This is great news for patients,” said Charles Sang, Adaptive’s senior vice president, adding that having Medicare coverage soon after FDA approval “further demonstrates the clinical relevance of MRD assessment and underscores the benefit that this test delivers in the management of myeloma and ALL patients.”

According to Sang, “clonoSEQ enables more cost-effective care by assessing the effectiveness of therapy, monitoring remission and identifying relapse in lymphoid blood cancers,” which represents a key tool “to help clinicians decide if a patient should initiate, pause or discontinue a potentially costly treatment regimen.”

The assay is a single-site test conducted at Adaptive. It is also available as a Clinical Laboratory Improvement Amendments (CLIA)-regulated laboratory developed service in other lymphoid cancers. clonoSEQ has been used in 25 of the 28 U.S. National Comprehensive Cancer Network centers. Adaptive is now working to increase the assay’s use in the community setting.

Adaptive is also working with third-party payers to obtain coverage of clonoSEQ for eligible patients. The company plans to expand clonoSEQ’s commercialization this year and will pursue FDA approval for clonoSEQ in other indications.

More details about the clonoSEQ coverage decision can be found here. Information about FDA-cleared uses of clonoSEQ, including limitations and detailed performance characteristics, is available here.

Adaptive is partnering with AmgenSanofi, and other companies for the use of the clonoSEQ Assay to determine MRD in multiple myeloma and ALL patients in clinical trials.