Medicare coverage of ClonoSEQ shows market progress for next-gen sequencing

27 February 2019 (Last Updated February 27th, 2019 14:26)

Adaptive Biotechnologies has received approval for Medicare coverage of its diagnostic assay, ClonoSEQ.

Medicare coverage of ClonoSEQ shows market progress for next-gen sequencing

Adaptive Biotechnologies has received approval for Medicare coverage of its diagnostic assay, ClonoSEQ. This immune profiling assay is run on the immune repertoire from a patient’s bone marrow. This test has received FDA approval for myeloma and acute lymphocytic leukemia.

It is the first and only next generation deoxyribonucleic acid (DNA)-sequencing (NGS) test to monitor minimal residual disease (MRD), the number of cancer cells that remain in a person during and following treatment. Those cells that survive the initial cancer treatment are often the ones that cause a patient to relapse. This test will benefit patients by providing them with better personalised treatment during their care. Patients can be assayed for relapse, and doctors can assess whether a patient should initiate or discontinue treatment for lymphoid cancer. Cost reductions in next-generation sequencing are allowing tests to emerge based on this technology.

The Centers for Medicare and Medicaid Services (CMS) modified its coverage determination for NGS diagnostic laboratory tests performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified lab effective 16 March 2018.  This, along with its FDA approval, allowed ClonoSEQ to be covered by Medicare. So far, coverage for ClonoSEQ was announced by Palmetto GBA, a Medicare Administrative Contractor that has jurisdiction in Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia and West Virginia.

The FDA approved the ClonoSEQ assay on 28 September 2018 via a de novo premarket review pathway targeting low to moderate risk devices. The FDA has also stated that it is seeking faster approval paths for novel diagnostics. To determine whether this announcement affected the overall activity for the web presence of Adaptive Biotechnologies, GlobalData investigated the website traffic for its site. There was an increase in website traffic for adaptivebiotech.com based on SimilarWeb’s per month visits data for these sites (see figure below).  This information was obtained from GlobalData’s Digital Marketing Intelligence platform. We will likely see a similar spike based on the Medicare approval announcement.

Figure 1: SimilarWeb estimated visits for adaptivebiotech.com

Next-generation diagnostics

Source: GlobalData Digital Marketing Intelligence, SimilarWeb