RaDaR Assay Gets FDA Designation for Expediated Regulatory Pathway

March 10, 2021
Audrey Sternberg

The liquid biopsy assay RaDaR has been given a breakthrough device designation for use in the detection of minimal residual disease in early-stage cancers.

Breakthrough device designation was granted to the RaDaR assay, which tracks up to 48 tumor-specific variants in a patient’s blood for use in the detection of minimal residual disease (MRD) in early-stage cancer, according to Inivata, the product’s developer.1

This designation will help to accelerate the regulatory pathway for the assay to become available for this indication.

“Receiving Breakthrough Device Designation is an important milestone for Inivata as we advance the development of our innovative RaDaR liquid biopsy test,” Clive Morris, CEO of Inivata, said in a press release. “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.”

The liquid biopsy assay may possibly aid clinicians in treating patients with early cancer following therapy by detecting residual disease not otherwise detectable by traditional methods as well as disease relapse. The next-generation sequencing platform uses built-in controls and error correction for high sensitivity and specificity.

RaDaR is manufactured using the InVision platform developed by Inivata, which was established for both its high level of sensitivity as well as its comprehensive ability to detect variants in the blood. According to the company’s website, the technology has the capability to detect more than 99% of single nucleotide variants at an allele frequency of 0.25% to 0.33% and more than 50% at an allele frequency as low as 0.06% to 0.08%.2

The RaDaR assay was launched in April 2020, with the promise of a 7-calendar day turnaround time for monitoring. Initial applications of the assay will be for clinical research, with its greater sensitivity allowing for more accurate patient selection and enriched clinical trial populations.3

In a presentation at the American Association of Clinical Research Annual Meeting 2020, RaDaR exhibited a mean sensitivity of 100% at 20 ppm (equivalent to 0.002%) and a sensitivity of 70% at 10 ppm (equivalent to 0.001%) when used to detect 48 variants in plasma samples. The approach was generalizable to multiple tumor and specimen types.4

In October 2020, Inivata announced that the RaDaR assay would be used for the detection and monitoring of residual disease and recurrence by way of circulating tumor DNA in patients enrolled in the phase 1/2 trial of MVC-101, a conditionally active T cell-engaging molecule designed to target EGFR.5

“ctDNA has shown promise as a predictive marker of early response for immunotherapies in solid tumor indications. The patient-specific design of the RaDaR assay enables the detection of residual disease with exceptional sensitivity in multiple tumor types and it is therefore a highly complementary technology to advance our Phase 1/2 study,” Jeremiah Degenhardt, PhD, vice president of Translational Oncology and Bioinformatics at Maverick Therapeutics, the company responsible for developing MVC-101, said in a press release. “The use of RaDaR will enable our team to more accurately measure treatment success throughout the trial for our novel COBRA platform.”

The breakthrough device designation is granted to novel medical devices that have the potential to significantly impact the treatment or diagnosis of life-threatening diseases and conditions, such as cancer, and provide health care providers with these essential tools in a timely manner.

References:

1. FDA Grants Breakthrough Device Designation for Inivata’s RaDaR™ Assay. Inivata. March 9, 2020. Accessed March 10, 2021. https://www.inivata.com/fda-grants-breakthrough-device-designation-for-inivatas-radar-assay/

2. InVision. Inivata website. Accessed March 10, 2021. https://www.inivata.com/invision-platform/

3. Inivata launches RaDaR assay for detection of residual disease and recurrence. News release. Inivata. April 23, 2020. Accessed March 10, 2021. https://www.globenewswire.com/news-release/2020/04/23/2020752/0/en/Inivata-Launches-RaDaR-Assay-for-Detection-of-Residual-Disease-and-Recurrence.html

4.Analytical development of the RaDaR assay, a highly sensitive and specific assay for the monitoring of minimal residual disease. Clin Cancer Res. 2020;80(16):3097. doi:10.1158/1538-7445.AM2020-3097

5. Inivata Announces Collaboration with Maverick Therapeutics for use of RaDaR Assay. News release. Inivata. April 23, 2020. Accessed March 10, 2021. https://www.inivata.com/inivata-announces-collaboration-with-maverick-therapeutics-for-use-of-radar-assay/