FDA Grants Breakthrough Device Designation the RaDaR Assay for Early-Stage Cancer Detection

The FDA granted Breakthrough Device Designation for RaDaR assay, a personalized liquid biopsy assay that tracks a set of up to 48 tumor-specific variants in patients with exceptional sensitivity, according to a press release by Inivata.

“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,” said Clive Morris, CEO of Inivata in a press release.

The assay detects residual disease following initial treatment in order to detect relapse early on. The assay is an extension of the pre-existing InVision liquid biopsy platform technology which uses built-in-controls and error-correction to detect with high sensitivity and specificity.

Need for such an assay stems from the fact that between 5% and 30% of patients with primary cancer relapse and die of metastatic disease. Minimal residual disease (MRD) is often targeted by adjuvant therapy, however, this rarely improves the outcome for most patients. Liquid biopsies can be a minimally invasive way of identifying patients with MRD who do not have macroscopic disease. This allows oncologists to better adjust treatment and improve patient outcomes.²

According to a presentation related to the RaDaR assay given during the 2020 American Association for Cancer Research Annual Meeting (AACR 2020), 3 cancer cell lines composing of more than 1000 positive reactions and 320 negative reactions were used. Additionally, 7 formalin-fixed paraffin-embedded tissue samples, including breast cancer, colon cancer, and melanoma, were used in the study along with 366 lung cancer samples. A wide range of detection was also found in the lung cancer cohort.²

In another study, the sensitivity of the RaDaR assay was evaluated in patients with stage IA-IIIB non–small cell lung cancer (NSCLC). The 90 patients were undergoing radical treatment with curative intent, according to a poster presented during AACR 2020. Of the 90 patients, 70 had undergone surgery while 20 had undergone radiotherapy or chemotherapy. Plasma samples were taken from each participant at follow-up visits, which occurred every 3 months for a 9-month period. Patients who underwent surgery had a sample taken within 72 hours after. Tumor-exome sequencing was performed to identify mutations and a RaDaR assay was developed for each patient. Residual disease data was then correlated with progression free survival.²

A total of 89 tests passed quality control. A median of 43 amplicons with a minimal target read depth of 40,000 per sample per variant also passed quality control. Together, these results show that the RaDaR assay can detect and monitor ctDNA in patients with NSCLC at the time to relapse or prior to relapse using patient-specific plasma sequencing assays.² 

“We look forward to working with the FDA as we move forward with the development of RaDaR,” said Clive Morris, CEO of Inivata in a press release.

_REFERENCE:

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

2. _{Marsico, G. Sharma, G., Perry, M. et al. Analytical development of the RaDaRTM assay, a highly sensitive and specific assay for the monitoring of minimal residual disease. Clin Can Res. 2020; 80 (suppl 16);3097. doi: 10.1158/1538-7445.AM2020-3097}

3. _{Heider, K., Gale, D., Valdepenas, A. eta l. Sensitive detection of ctDNA in early-stage non-small cell lung cancer patients with a personalized sequencing assay. Clin Can Res. 2020; 80 (suppl 16);735. doi: 10.1158/1538-7445.AM2020-735}