The DETECTR BOOST SARS-CoV-2 reagent kit combines the potential of CRISPR with laboratory automation for SARS-CoV-2 testing
Mammoth Biosciences has secured FDA EUA for CRISPR-based Covid-19 test. (Credit: Thomas G. from Pixabay)
Mammoth Biosciences has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its first CRISPR-based high-throughput Covid-19 test.
The DETECTR BOOST SARS-CoV-2 reagent kit is said to be the first of its kind high-throughput solution, which combines the potential of CRISPR with laboratory automation for SARS-CoV-2 testing.
The DETECTR BOOST platform is a turnkey and CRISPR-based molecular diagnostic system that facilitates high-throughput and sample-to-answer testing with PCR-equivalent performance and minimal hands-on time.
In combination with the Agilent Bravo BenchCel DB liquid handling platform, Mammoth’s DETECTR BOOST SARS-CoV-2 reagent kit allows the detection of 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.
The test has to be conducted in high complexity CLIA laboratories, said the company.
Mammoth Biosciences co-founder and CTO Dr Janice Chen said: “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.
“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 is not yet approved by the FDA.
Supported by the NIH Rapid Acceleration of Diagnostics (RADx) programme, the project secured funding under Federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services.
In October last year, Vertex Pharmaceuticals and Mammoth Biosciences partnered to develop in vivo gene-editing therapies for two genetic diseases using Mammoth’s next-generation CRISPR systems.