Inivata Ltd.. (3/9/21). "Press Release: FDA Grants Breakthrough Device Designation for Inivata’s RaDaR Assay". Research Triangle Park, NC & Cambridge.

	Region	United States (USA)
	Organisation	Inivata Ltd.
	Group	NeoGenomics (Group)
	Organisation 2	FDA (US Food and Drug Administration)
	Group	United States (govt)
	Product	RaDaR™ minimal residual disease assay
	Person	Morris, Clive (Inivata 201807–202205 CEO before CMO joined 201605 before AstraZeneca LEFT 5/22)

Designation will help accelerate the regulatory path of RaDaR for use in detection of MRD in early-stage cancer patients

Inivata, a leader in liquid biopsy, today announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its RaDaR™ assay.

RaDaR is a personalized assay that tracks a set of up to 48 tumor-specific variants in a patient using a liquid biopsy with exceptional sensitivity. The assay potentially allows detection of residual disease following initial treatment and early detection of relapse. RaDaR is built on Inivata’s proven InVision® liquid biopsy platform technology. This next-generation sequencing platform incorporates built-in controls and error-correction for highly sensitive and specific variant detection.

The FDA’s Breakthrough Devices program targets novel medical devices that have the potential to provide patients with a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases and conditions. The program provides patients and healthcare providers with timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards consistent with the FDA’s mission to protect and promote public health.

Clive Morris, CEO of Inivata, commented:
“Receiving Breakthrough Device Designation is an important milestone for Inivata as we advance the development of our innovative RaDaR liquid biopsy test. Identification of patients with residual disease following initial therapy has the potential to accelerate both the development and future use of therapies for patients with early stage cancers. We look forward to working with the FDA as we move forward with the development of RaDaR.”

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.

For more information, please go to www.inivata.com. Follow Inivata on Twitter @Inivata.

Media Contacts

Consilium Strategic Communications
Chris Gardner/Angela Gray/Sarah Wilson
Alix Floyd (US) +1 281 433 7604
inivata@consilium-comms.com
+44 (0)20 3709 5700

Karen Chandler-Smith
karen.chandler-smith@inivata.com
+44 (0)7900 430235

Record changed: 2023-06-05