Inivata, Agendia To Commercialize RaDaR That Locks In On Breast Cancer
This “radar” can detect breast cancer. And it may soon be available to clinicians near you.
UK-headquartered Inivata, which has a laboratory presence in Research Triangle Park, has entered into a commercialization agreement with Amsterdam-based Agendia, Inc. to distribute Inivata’s RaDaR liquid biopsy assay.
The test tracks a set of up to 48 tumor-specific variants in patients’ blood samples to detect minimal residual disease (MRD) and early relapse in patients with breast cancer.
MRD is a term used to describe the small number of cancer cells that remain in the body during or after treatment that can only be found by highly sensitive laboratory methods.
Under the agreement, Agendia will gain co-exclusive rights to distribute RaDaR in North America and Europe with the option to extend territories over time. The assay has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration.
“We believe that the use of highly sensitive liquid biopsy approaches to detect MRD has the potential to transform cancer care by providing clinicians with timely, accurate information about whether the disease may have recurred, allowing a window for intervention and the prospect of better outcomes,” said Inivata CEO Clive Morris.
Mark Straley, CEO of Agendia, added that “the partnership with Inivata is a natural progression for Agendia to guide breast cancer care from diagnosis to surgery, treatment to monitoring and beyond to ensure timely information to manage care.”
The two companies said RaDaR is expected to be available to clinicians and reimbursed in the United States in 2022. They reported that proof-of-principle data have shown that the assay performs with “exceptionally high sensitivity” in early-stage breast cancer studies. It will help physicians better manage pre-and-post operative care for breast cancer patients and check for relapse of the disease.
Inivata’s approximately 50 RTP employees process liquid biopsy samples from a range of different cancer types. The company is a leader in liquid biopsy technology that unlocks genomic information from patients’ blood samples. Its leading product, InVisionFirst-Lung is used to help clinicians make treatment decisions for patients with advanced non-small-cell lung cancer.
Agendia is a molecular diagnostics company that focuses only on breast cancer. In addition to the Netherlands, the company has operations in Irvine, California. It currently offers two commercially available genomic tests for the disease that provide a comprehensive genomic profile. MammaPrint is a 70-gene breast cancer recurrence assay and BluePrint is an 80-gene molecular subtyping assay.