Inivata and Agendia Sign Agreement for Commercialization of RaDaR® MRD Liquid Biopsy Assay in Breast Cancer

Research Triangle Park, NC, USA, Cambridge, UK, Irvine, Calif., and Amsterdam – 28 April 2021 – Inivata, a leader in liquid biopsy, today announced it has entered a commercialization agreement with Agendia, Inc., a leader in precision oncology 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 an innovative, highly sensitive personalized liquid biopsy assay that tracks a set of up to 48 tumor-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 [LINK].

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.[1]  As Agendia continues to build its brand as a leading women’s health company in breast cancer, the partnership and further addition of genomic tools and capabilities are a natural advancement that will impact not only health outcomes, but overall quality of life for patients living with and beyond breast cancer.

Clive Morris, CEO of Inivata, commented: “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 commercialize 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, said: “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.”

About Inivata

Inivata is a leader in liquid biopsy. Its InVision® platform unlocks essential genomic information from a simple blood draw to guide and personalize cancer treatment, monitor response and detect relapse. Inivata’s technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge. Its lead product, InVisionFirst®-Lung is commercially available internationally and through NeoGenomics in the US. It offers competitive sensitivity and turnaround, providing molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata has also launched the personalized RaDaR® assay – allowing the highly sensitive detection of residual disease and recurrence – which has been granted Breakthrough Device Designation by the US FDA. Inivata is partnering with pharmaceutical, biotechnology companies and commercial partners in a range of early and late-stage cancer development programs. The Company has a CLIA certified, CAP accredited laboratory in Research Triangle Park, NC and R&D laboratories in Cambridge, UK.

About RaDaR®

RaDaR is Inivata’s assay for the detection of molecular residual disease (MRD) and recurrence. Built on Inivata’s proven InVision® liquid biopsy platform technology, RaDaR is a highly sensitive personalized assay that tracks a set of up to 48 tumor-specific variants in a patient using a liquid biopsy, allowing both detection of residual disease following curative intent or definitive treatment, and early detection of relapse. RaDaR has been granted Breakthrough Device Designation by the US FDA.

About Agendia

Agendia is a precision oncology company headquartered in Irvine, California, committed to bringing early stage patients with breast cancer and their physicians the information they need to make the most effective treatment decisions. The company currently offers two commercially-available genomic profiling tests, supported by clinical and real world evidence. MammaPrint®, the 70-gene breast cancer recurrence assay, and BluePrint®, the 80-gene molecular subtyping assay, provide a comprehensive genomic profile and the data physicians need to make more informed decisions in the pre- and post-operative treatment settings. Agendia develops evidence-based novel genomic tests and forges partnerships with groundbreaking companies to develop next-generation digital treatment tools. The ongoing research builds an arsenal of data that improve patient outcomes and support the evolving clinical needs of patients with breast cancer and their physicians every step of the way, from initial diagnosis to cancer-free.

For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com.