Adaptive Biotechnologies Receives Expanded Medicare Coverage of clonoSEQ® for Surveillance in Mantle Cell Lymphoma

Rhea-AI Summary

Adaptive Biotechnologies (Nasdaq: ADPT) has secured expanded Medicare coverage for its clonoSEQ® test in mantle cell lymphoma (MCL) surveillance. The coverage now includes single time point testing to monitor disease recurrence in patients during treatment-free remission.

Under the expanded coverage by Palmetto GBA, patients who have completed treatment can receive clonoSEQ testing every six months for up to five years during treatment-free remission, followed by annual testing until disease recurrence. The test pricing is set at $2,007 per test under the Clinical Laboratory Fee Schedule.

MCL, affecting approximately 4,000 new cases annually in the United States, is the first clonoSEQ indication to receive this coverage determination. The test is performed at Adaptive's CLIA-certified lab in Seattle and has received approval from New York State's Clinical Laboratory Evaluation Program.

Positive

• Secured expanded Medicare coverage for clonoSEQ testing in MCL surveillance
• Coverage includes regular testing for up to 5 years post-treatment
• Established pricing of $2,007 per test under Medicare
• Test is already approved by NY State's Clinical Laboratory Evaluation Program

Negative

• None.

Insights

Healthcare Financial Analyst

The expanded Medicare coverage for Adaptive's clonoSEQ test in mantle cell lymphoma (MCL) surveillance represents a significant revenue opportunity and reimbursement milestone. Under this coverage determination, MCL patients in remission will receive covered testing every six months for five years, then annually until recurrence is detected—substantially expanding the utilization window beyond active treatment.

At the established $2,007 per test reimbursement rate, this creates a meaningful long-term revenue stream per patient. With approximately 4,000 new MCL cases annually in the US, and considering Medicare's dominant coverage position in this predominantly older patient population, the recurring revenue potential is substantial.

Most critically, this coverage determination establishes a precedent that could be applied to other clonoSEQ indications. The company's statement that this "establishes a framework for potential expanded coverage" in other indications suggests this could be the first of multiple similar coverage expansions, which would multiply the financial impact.

The clinical value proposition is compelling: MCL patients frequently relapse even years after achieving remission, creating genuine clinical necessity for ongoing surveillance with sensitive testing methods. This alignment of clinical utility with favorable reimbursement positions clonoSEQ favorably in the precision oncology diagnostic market.

Oncology Specialist

This Medicare coverage expansion for clonoSEQ in MCL surveillance addresses a critical clinical need in lymphoma management. MCL represents a particularly challenging malignancy with late relapses occurring up to 15 years after initial remission, making long-term surveillance essential but previously difficult to justify without coverage.

The ability to detect molecular recurrence through blood-based MRD testing offers significant advantages over traditional surveillance methods. clonoSEQ can detect disease re-emergence at much lower levels than imaging, allowing for earlier intervention when disease burden is minimal. The coverage structure—biannual testing for five years followed by annual testing—aligns with typical recurrence patterns in MCL.

What's particularly valuable is how this approach may "limit or guide imaging" in post-treatment surveillance. Rather than subjecting patients to frequent CT scans with associated radiation exposure, clinicians can potentially reserve imaging for when molecular recurrence is detected, creating a more rational, evidence-based surveillance paradigm.

This coverage decision validates the growing recognition that MRD assessment represents a paradigm shift in lymphoma management, moving from morphologic to molecular disease monitoring. For MCL patients specifically, who live with the psychological burden of knowing recurrence is likely, regular blood-based monitoring may provide both clinical utility and psychological reassurance.

clonoSEQ is now covered to monitor for recurrence in MCL patients who are in treatment-free remission

SEATTLE, April 08, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses diagnostic technologies through its Molecular Diagnostic Services Program (MolDX), has expanded coverage of clonoSEQ^® to include single time point testing to monitor for recurrence in patients with a history of mantle cell lymphoma (MCL).

This expanded coverage is in addition to the existing Medicare episode payment structure for clonoSEQ, which provides coverage for a bundle of tests to assess response to therapy while a patient is being treated. 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 (CLFS) rate of $2,007 per clonoSEQ test.

“Securing coverage for clonoSEQ use in the MCL surveillance setting is a significant win for MCL patients. This coverage expansion enables clinicians to more effectively monitor and manage these patients who are at risk of relapse,” said Ben Eckert, senior vice president, Market Access, Adaptive Biotechnologies. “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.”

MCL is a sub-type of non-Hodgkin lymphoma (NHL) with an annual incidence of approximately 4,000 cases per year in the United States.¹ MRD is assessed through a series of tests over an MCL patient’s cancer journey and leverages blood to assess response, understand prognosis, and monitor patients to detect molecular recurrence. With modern treatment regimens, most patients will achieve disease remission after completion of front-line therapy and maintenance. However, due to the nature of MCL, many patients eventually relapse, some as late as 15 years after initial remission. Therefore, ongoing recurrence monitoring is particularly important in MCL, and clonoSEQ MRD testing in blood provides longitudinal insights that can be used to limit or guide imaging in this setting.

clonoSEQ 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 (CLEP).

About clonoSEQ
clonoSEQ is the first and only FDA-cleared in vitro diagnostic (IVD) test service to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing for patients with diffuse large B-cell lymphoma (DLBCL) is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle. clonoSEQ is CE-marked under the In Vitro Diagnostic Regulation (IVDR) in the European Union (EU). For the approved intended use in the EU under IVDR, please refer to the instructions for use, available on request.

clonoSEQ leverages Adaptive Biotechnologies’ proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate, and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to treatment, inform changes in therapy, monitor disease burden over time, and detect potential relapse early. Clinical practice guidelines in hematologic malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM, B-ALL and DLBCL.

For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary.

About Adaptive Biotechnologies
Adaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business segments: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer and autoimmune disorders. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.

Forward Looking Statements
This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

ADAPTIVE INVESTORS:
Karina Calzadilla, Vice President, Investor Relations and FP&A
201-396-1687
investors@adaptivebiotech.com

ADAPTIVE MEDIA:
Erica Jones, Associate Director, Corporate Communications
845-344-7542
media@adaptivebiotech.com

¹ Kallam A, Vose J. Current treatments in mantle cell lymphoma. Oncology. 2023;37:326-333. https://www.cancernetwork.com/view/current-treatments-in-mantle-cell-lymphoma. Accessed November 5, 2024.

FAQ

What is the new Medicare coverage expansion for Adaptive Biotechnologies' clonoSEQ test (ADPT)?

Medicare now covers single time point testing to monitor disease recurrence in mantle cell lymphoma patients during treatment-free remission, with testing every 6 months for 5 years and annually thereafter.

How much does the clonoSEQ test cost under the new Medicare coverage?

The clonoSEQ test is priced at $2,007 per test under the Clinical Laboratory Fee Schedule.

How frequently can MCL patients receive covered clonoSEQ testing under the new Medicare policy?

Patients can receive covered testing every 6 months for up to 5 years during treatment-free remission, followed by annual testing until disease recurrence.

What is the market size for mantle cell lymphoma that clonoSEQ can address?

Mantle cell lymphoma has an annual incidence of approximately 4,000 new cases per year in the United States.

Where is the clonoSEQ test for MCL patients currently performed?

The test is performed as a laboratory-developed test at Adaptive's CLIA-certified lab in Seattle.