Inivata and Agendia enter agreement over assay for MRD and breast cancer relapse

Liquid biopsy specialist Inivata has entered into a commercialisation agreement with Agendia, a precision oncology firm for breast cancer.

Under the terms of the agreement, Agendia will gain co-exclusive rights to distribute Inivata’s RaDaR liquid biopsy assay for the detection of Minimal Residual Disease (MRD) and early detection of relapse in patients with breast cancer in North America and Europe, with the option of extending territories over time. It is expected that the RaDaR assay will be reimbursed and available to clinicians in the US during 2022. Financial and commercial terms were not disclosed.

RaDaR is a personalised liquid biopsy assay that tracks a set of up to 48 tumour-specific variants in a patient using a simple blood draw, allowing both the detection of residual disease following curative intent or definitive treatment, and early detection of relapse. Proof-of-principle data presented at this year’s AACR Annual Meeting showed RaDaR performed with exceptionally high sensitivity (100% MRD detection) in early-stage breast cancer studies.

RaDaR is an important addition to Agendia’s precision oncology platform, which includes the MammaPrint risk of recurrence test and BluePrint molecular subtyping test. The addition of RaDaR will empower physicians to better triage pre- and post-operative care for patients with breast cancer, and to guide patients back to health while monitoring for early indicators of relapse. The partnership further expands Agendia’s addressable markets and could potentially provide a desperately needed option for more than five million patients with breast cancer across the US and Europe.

Clive Morris, CEO of Inivata, said: “Agendia is a proven leader in providing physicians with precision oncology tools to improve the treatment of patients with breast cancer and we are proud that they have chosen to work with us to commercialise our RaDaR assay. 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.”

Mark Straley, chief executive, Agendia, added: “Inivata is a pioneer in liquid biopsy. The RaDaR assay complements our MammaPrint and BluePrint tests, already used worldwide to provide actionable insights for the prognosis and treatment path in early breast cancer. 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. RaDaR will add to our leading market position in breast cancer with a repeat testing model and give us the opportunity to provide a comprehensive offering for patients at every stage of their journey.”