FDA Grants Breakthrough Device Designation for Inivata’s RaDaR™ Assay
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.