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Mammoth Biosciences, Agilent to Comarket CRISPR-Based SARS-CoV-2 Test

NEW YORK – Mammoth Biosciences said on Thursday that it has signed a comarketing agreement with Agilent Technologies for the launch of a high-throughput CRISPR-based SARS-CoV-2 diagnostic test composed of Agilent's Bravo automation workstation and Mammoth's DETECTR BOOST SARS-CoV-2 assay.

Financial terms of the deal were not disclosed.

The DETECTR BOOST SARS-CoV-2 Kit and Agilent automated liquid handling system will provide a complete workflow for high-throughput, sample-to-answer COVID-19 testing for commercial laboratories that enables a multifold increase in testing capacity compared to most currently available solutions, Mammoth said. The assay and automation solution will use Agilent's Bravo Liquid Handling System, including the Bravo BenchCel DB Workstation and BioTek plate readers, which the partners estimate will be able to perform more than 4,000 COVID-19 tests per day.

Agilent acquired Biotek, which sold instruments for the life science industry such as cell imaging systems and microplate readers, in July 2019 for $1.17 billion.

"This partnership will help address the need for more widespread testing options for COVID-19, helping to fill the gap in the market as testing labs run into supply issues or reach capacity," Mammoth Cofounder and CEO Trevor Martin said in a statement.

David Edwards, associate vice president for marketing in the Agilent mass spectrometry division, also noted that a highly automated workstation for SARS-CoV-2 diagnostics makes routine testing possible, adding, "By partnering with Mammoth Biosciences, we will be able to provide a simplified workflow that addresses the specific needs of high-throughput clinical testing laboratories."

Mammoth said it plans to submit the assay to the US Food and Drug Administration for Emergency Use Authorization soon.

In October, Mammoth signed agreements with MilliporeSigma and Hamilton Company to commercialize the DETECTR BOOST SARS-CoV-2 assay. At the time, the partners said the reagent kits would be contract manufactured by MilliporeSigma and the testing system would use standard, automated liquid handling equipment such as those from Hamilton Company to enable rapid processing of patient samples.

The company's DETECTR-based SARS-CoV-2 test development 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, a low-throughput system, can be used by any lab that's CLIA-certified to perform high-complexity tests.