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Invitae, Pharma Firms Partner to Develop Standard MRD Panel for AML Clinical Trials

NEW YORK – Invitae on Thursday said it will collaborate with Bristol Myers Squibb, Janssen Research & Development, Novartis, and Genentech to develop a next-generation sequencing-based panel for standardized minimal residual disease (MRD) detection in acute myeloid leukemia patients.

The companies want to standardize MRD measurement methods so that it can be used as a clinical trial endpoint for determining the efficacy of AML treatments and as a biomarker for predicting patients' survival after treatment. Although MRD is established as a prognostic biomarker for determining patients' risk of relapse or recurrence, lack of standardization in testing methods has slowed its adoption as a clinical trial endpoint, according to Invitae. 

"Given the existing evidence that shows assessing the presence of MRD can provide valuable information on how well a treatment may be working, we hope to further establish MRD detection as an objective tool for clinicians to create the best treatment plan for individual patients," Jason Myers, Invitae's president of oncology, said in a statement. "Together with leading, global biopharmaceutical companies … we intend to develop a panel that can accurately measure and standardize MRD data collection in clinical trials with the goal of accelerating trial timeframes to bring novel therapies to patients in need sooner."

Invitae envisions that the multi-gene, next-generation sequencing panel it will develop with its pharma partners will be used in AML studies to gauge patients' molecular status at baseline, but also to monitor their MRD status during the trial. The panel will use Invitae's anchored multiplex PCR chemistry, which the company said will allow labs at local clinical trial sites to perform testing and reduce turnaround times. According to Invitae, the panel will be able to detect more than 90 percent of AML-associated genetic alterations, including in the CEBPA, FLT3, IDH1, and IDH2 genes.