clonoSEQ Assay is indicated to analyse DNA from bone marrow samples for the detection and monitoring of MRD in multiple myeloma (MM) and B-cell acute lymphoblastic leukaemia (ALL) patients.
The in-vitro diagnostic uses Adaptive’s immunosequencing platform to identify and quantify specific DNA sequences present in malignant cells. Clinicians can leverage the test to check for MRD during and after treatment.
It can also be used to predict outcomes in patients, examine treatment response over time, monitor remission and identify potential relapse.
The next-generation sequencing (NGS)-based assay holds the US Food and Drug Administration (FDA) marketing authorisation.
Amgen global development vice-president Gregory Friberg said: “It is critical to know a patient’s MRD status because treating to MRD negativity has been shown to drive better clinical outcomes for patients in a variety of blood cancers.
“Standardised, highly sensitive, molecular detection of MRD using clonoSEQ supports the development of potential cancer therapies that can help patients with blood cancer live longer.”
The pharmaceutical company formed an alliance with Adaptive in 2016 to assess MRD in ALL indication.
Under the latest four-year agreement, Amgen will use Adaptive’s assay in several drug development programmes under its haematology portfolio, including marketed and pipeline blood cancer drugs.
In turn, Adaptive will gain annual development fees, along with sequencing payments and regulatory milestones. The company will provide MRD testing and analysis for ongoing as well as future clinical trials.
Adaptive Biotechnologies CEO and co-founder Chad Robins said: “This pan-portfolio partnership reflects Amgen’s confidence in the role that standardised NGS MRD testing with clonoSEQ plays in demonstrating drug efficacy in clinical trials and in day-to-day patient management.”
Data captured as part of the alliance will be used by Adaptive to support the use of MRD as a measure of patient outcomes.