NEW YORK – Mammoth Biosciences said on Thursday that it has signed agreements with MilliporeSigma and Hamilton Company to commercialize a high-throughput, CRISPR-based SARS CoV-2 test.
The test uses Mammoth's DETECTR BOOST platform to provide a sample-to-answer solution for commercial laboratories, enabling a multifold increase in testing capacity, the company said. Mammoth's DETECTR BOOST SARS-CoV-2 assay reagent kits will be contract manufactured by MilliporeSigma, and the testing system will leverage standard, automated liquid handling equipment such as those from Hamilton Company to enable rapid processing of patient samples.
The platform will be compatible with both nasal swab and saliva samples, and the company is aiming for completion of 1,500 tests per eight-hour shift, with minimal user interaction. Mammoth plans to submit the assay to the US Food and Drug Administration for Emergency Use Authorization later this year.
"In order to begin reopening more aspects of society, we'll need a robust testing infrastructure that can rapidly scale up capacity as needed," Mammoth Cofounder and CEO Trevor Martin said in a statement. "By combining CRISPR-based diagnostics with the proven manufacturing and product leadership of MilliporeSigma and Hamilton Company, we're confident this solution will be a game-changer for labs."
This project is being supported by a grant from the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) program, Mammoth said. The NIH launched RADx on April 29, after receiving an emergency supplemental appropriation of $1.5 billion from Congress to support the development of technologies that could make millions of rapid COVID-19 tests per week available by the fall. At the end of July, the agency awarded the first tranche of funds, including an undisclosed amount to Mammoth to scale up, manufacture, and deliver its SARS-CoV-2 DETECTR assay to the marketplace.
Mammoth's SARS-CoV-2 DETECTR Reagent Kit — a CRISPR-based RT-LAMP test designed for the detection of the virus' N gene in upper respiratory specimens — was awarded EUA by the FDA in September. That test can be used by any lab that's CLIA-certified to perform high-complexity tests.