Mammoth Biosciences Receives FDA Emergency Use Authorization for First CRISPR-based High-Throughput COVID-19 Test

January 24, 2022 |

2 min read

Mammoth Biosciences, Inc. , today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its DETECTR BOOST ® SARS-CoV-2 Reagent Kit, a first of its kind high-throughput solution that combines the power of CRISPR with laboratory automation for SARS-CoV-2 testing.

Jan. 24, 2022 17:23 UTC

BRISBANE, Calif.--(BUSINESS WIRE)-- Mammoth Biosciences, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its DETECTR BOOST^® SARS-CoV-2 Reagent Kit, a first of its kind high-throughput solution that combines the power of CRISPR with laboratory automation for SARS-CoV-2 testing.

The DETECTR BOOST platform is a turnkey, CRISPR-based molecular diagnostic system that enables high-throughput, sample-to-answer testing with PCR-equivalent performance and minimal hands-on time. Together with the Agilent Bravo BenchCel DB liquid handling platform, the DETECTR BOOST^® SARS-CoV-2 Reagent Kit detects SARS-CoV-2 RNA in nasopharyngeal, anterior nasal, mid-turbinate nasal or oropharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider, and the test is performed in high complexity CLIA laboratories.

“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, Ph.D., co-founder and CTO of Mammoth Biosciences. “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, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. For more information, please visit www.mammoth.bio/covid.

This project is supported by the NIH Rapid Acceleration of Diagnostics (RADx) program and has been funded in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00011.

About Mammoth Biosciences

Mammoth Biosciences, Inc. is harnessing the diversity of nature to power the next-generation of CRISPR products. Through the discovery and development of novel CRISPR systems, the company is enabling the full potential of its platform to read and write the code of life. By leveraging its internal research and development and exclusive licensing to patents related to Cas12, Cas13, Cas14 and CasΦ, Mammoth Biosciences can provide enhanced diagnostics and genome editing for life science research, healthcare, agriculture, biodefense and more. Based in Brisbane, California, Mammoth Biosciences is co-founded by Nobel Prize winner and CRISPR pioneer Jennifer Doudna as well as Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Redmile Group, Foresite Capital, Senator Investment Group, Sixth Street, Decheng, Mayfield, NFX, and 8VC.