FDA Grants Emergency Use Authorization to CRISPR High Throughput COVID-19 Test

The FDA has granted Emergency Use Authorization (EUA) to Mammoth Biosciences, Inc, for its DETECTR BOOST SARS-CoV-2 Reagent Kit, which combines CRISPR technology with laboratory automation for SARS-CoV-2 testing.

The platform is a CRISPR-based molecular diagnostic system that enables high-throughput, sample-to-answer testing with PCR-equivalent performance and minimal hands-on-time. The kit helps detect SARS-CoV-2 RNA in nasopharyngeal, anterior nasal, mid-turbinate nasal or oropharyngeal swab specimens from individuals suspected of COVID-19 by their health care provider.

“Mammoth’s DETECTR BOOST SARS-CoV-2 assay rivals best-in-class PCR performance and this emergency use authorization is another important step towards our mission to harness the full potential of CRISPR to improve lives,” said Janice Chen, PhD, co-founder and CTO of Mammoth Biosciences, in a press release. “We are proud of the team, our partners and sponsors for their commitment to developing novel testing solutions to address the COVID-19 pandemic.”

The DETECTR BOOST SARS-CoV-2 Reagent Kit has not been FDA cleared or approved, and the project is supported by the National Institutes of Health Rapid Acceleration of Diagnostics program in part with the National Institute of Biomedical Imaging and Bioengineering.

REFERENCE

Mammoth Biosciences Receives FDA Emergency Use Authorization for First CRISPR-based High-Throughput COVID-19 Test. BusinessWire. January 24, 2022. Accessed January 25, 2022. https://www.businesswire.com/news/home/20220124005618/en