Adaptive Biotechnologies cites clonoSEQ in new myeloma cure definition

A new IMS consensus definition places sustained MRD negativity at the centre of determining cure in multiple myeloma, boosting the case for NGS-based testing.

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Adaptive Biotechnologies has moved to position its clonoSEQ assay at the heart of a landmark shift in how multiple myeloma treatment outcomes are classified, following the publication of a new international consensus definition of cure at the International Myeloma Society (IMS) 23rd Annual Meeting in Glasgow.

The definition, developed jointly by IMS and the International Myeloma Working Group (IMWG), marks a significant conceptual shift for a disease that was long regarded as incurable. Under the new framework, patients with newly diagnosed or relapsed myeloma may be considered cured after five years in complete remission without treatment, provided they meet a set of stringent monitoring criteria throughout that period.

What the cure criteria require

The consensus standard mandates at least four negative MRD assessments during the five-year window, including one at the final mark, with no positive result in between. Critically, those tests must achieve a sensitivity of 10 to the power of minus six, meaning one myeloma cell detected among one million normal cells. Advanced imaging via PET/CT or diffusion-weighted whole-body MRI is also required at the start and end of the observation period.

Jeffrey Wolf, clinical professor in the Department of Medicine at the University of California San Francisco, said the field had now reached a point where cure was a realistic outcome for some patients. "The ideal way of measuring that is to use the clonoSEQ Assay, which has been proven over many years to be the most reproducible way of defining residual disease in these patients," he said.

Susan Bobulsky, chief commercial officer for MRD at Adaptive Biotechnologies, noted that the consensus definition arrived alongside a recent update to the National Comprehensive Cancer Network (NCCN) Guidelines affirming routine MRD assessment in myeloma care. The company said clonoSEQ is the first and only FDA-cleared next-generation sequencing test for MRD detection in multiple myeloma, giving it a regulatory distinction that competitors using laboratory-developed test frameworks cannot currently match.

Market context and competitive landscape

The myeloma MRD testing market has grown substantially in step with the arrival of deeper-acting therapies, including CAR-T cell products, bispecific antibodies and modern quadruplet induction regimens, all of which are capable of driving patients to MRD-negative status at rates that were not achievable a decade ago. That deeper-response landscape has created a genuine clinical need for the kind of standardised, high-sensitivity monitoring the new consensus definition now formalises.

Adaptive is not the only player pursuing next-generation sequencing-based MRD. Competitors include flow cytometry platforms and other sequencing-based approaches used in academic and commercial laboratories across the US and Europe. However, FDA clearance and Medicare coverage across multiple haematological malignancies, including myeloma, CLL and B-cell acute lymphoblastic leukaemia, provide Adaptive with a reimbursement and credentialling advantage that is difficult for laboratory-developed tests to replicate without their own regulatory submissions.

The new cure definition will also amplify demand beyond routine monitoring. Regulators and trial sponsors are increasingly using MRD negativity as a surrogate endpoint in myeloma pivotal trials, a trend reinforced by the FDA's own guidance on novel endpoints in haematological cancers. If MRD-negative status at 10 to the power of minus six becomes a de facto standard for regulatory submissions as well as clinical practice, the addressable market for clonoSEQ expands materially.

For patients, the shift carries both promise and complexity. Jenny Ahlstrom, myeloma patient and founder of the HealthTree Foundation, cautioned that the diversity of myeloma biology means not all patients will be candidates for cure designation, and that understanding which subpopulations can achieve durable remission remains one of the field's most pressing research questions.

Adaptive's next disclosed milestones will centre on commercial adoption of the updated guidelines and potential expansion of clonoSEQ's label or coverage into additional indications.

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