22 January 2019 - - US-based immune driven-medicine company Adaptive Biotechnologies, said that Palmetto GBA, a Medicare Administrative Contractor and specialist in assessing diagnostic technologies through its MolDX programme, has established coverage of the clonoSEQ Assay for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia.

clonoSEQ is the first and only test authorised by the US Food and Drug Administration to detect and monitor minimal residual disease in myeloma and ALL using DNA from a patient's bone marrow sample.

The Medicare coverage for clonoSEQ is aligned with the assay's FDA label and with clinical practice guidelines in myeloma and ALL and includes assessing MRD at multiple time points throughout therapy to monitor treatment response and help predict patient outcomes. The article, also posted by the MAC Noridian, is effective immediately and enables national coverage of Medicare patients undergoing clonoSEQ testing.

MRD refers to the remaining number of cancer cells that are present in a patient's body during and after treatment and may eventually lead to recurrence of the disease.

Cancer treatment guidelines for myeloma and ALL call for MRD testing to assess disease burden throughout the course of care to help monitor for remission, detect relapse, determine response to treatment and predict patient outcomes. Controlled trials have shown that even the smallest amounts of residual disease significantly predict a patient's long-term clinical outcomes.

clonoSEQ testing has been used in 25 of the 28 of the National Comprehensive Cancer Network centers in the US, and Adaptive is working diligently with community practice leaders to increase use in the community setting.

As MRD assessment becomes standard practice for patient management across a range of blood cancers, it is essential that clinicians and patients have access to a highly accurate, sensitive and standardized MRD assessment tool. Having satisfied the analytical and clinical validation requirements of the FDA and met the bar for clinical utility required by Medicare, the clonoSEQ Assay addresses this need.

Adaptive continues to work closely with third-party payers to obtain coverage of clonoSEQ for eligible patients in need. With Medicare coverage in place, Adaptive is strongly positioned to expand commercialization of clonoSEQ in 2019. The company is committed to pursuing regulatory approval for additional potential indications for clonoSEQ in other blood cancers and sample types, including blood-based MRD assessment.

The Adaptive Biotechnologies clonoSEQ Assay has been granted De Novo designation by the FDA as an in vitro diagnostic to detect and monitor minimal residual disease in patients with multiple myeloma and B-cell acute lymphoblastic leukemia using DNA from bone marrow samples. It identifies and quantifies specific DNA sequences found in malignant cells, allowing clinicians to monitor patients for changes in disease burden during and after treatment.

This robust assay provides sensitive and accurate measurement of residual disease that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and detect potential relapse. The clonoSEQ Assay is a single-site assay performed at Adaptive Biotechnologies.

It is also available as a CLIA-regulated laboratory developed test service for use in other lymphoid cancers.

clonoSEQ was reviewed under the FDA's De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk novel devices for which there is no legally marketed predicate device.

Adaptive Biotechnologies is a pioneer and leader in immune-driven medicine that aims to improve people's lives by learning from the wisdom of their adaptive immune systems.

Adaptive's proprietary immune profiling platform reveals and translates insights from our adaptive immune systems with unprecedented scale and precision.

Working with drug developers, clinicians and academic researchers, we are applying these insights to develop products that will transform the way diseases such as cancer, autoimmune conditions, and infectious diseases are diagnosed and treated.