The South San Francisco, California-based company’s high-throughput systems will be compatible with both nasal swab and saliva samples. Mammoth, which is targeting around 1,500 tests per eight-hour shift with minimal user interaction, plans to submit the assay for an Emergency Use Authorization from the US Food and Drug Administration (FDA) later this year.

With the new test, Clinical Laboratory Improvement Amendments labs in the US will be able to significantly improve capacity to regularly perform testing, Mammoth said, adding that the tests are expected to use a CRISPR-based workflow that reduces the time required for testing while maintaining the “gold standard” accuracy of Polymerase Chain Reaction expected by lab operators.

Merck’s life science arm will serve as the contract manufacturer of its partner’s DETECTR BOOST SARS-CoV-2 reagent kit, which will use standard, automated liquid handling equipment to allow rapid processing of patient samples and thus detect Covid-19 quickly. Production will take place at the German pharmaceuticals, chemicals and life sciences group’s US Life Science Center in St. Louis, Missouri.

The collaboration will allow Merck to help Mammoth with the development and  production of its new program that once approved by the FDA will increase US testing capacity at the scale needed to combat the pandemic, said Jean-Charles Wirth, head of Applied Solutions, Life Science.

 “Leveraging the proven manufacturing and product leadership of the Life Science business of Merck is critical to Mammoth delivering a CRISPR-based diagnostic solution to labs,” said Janice Chen, the company’s co-founder and chief technology officer.

The Merck business unit offers a broad range of products and services for clinical and diagnostic testing laboratories as well as the food and beverage industry, which it says provide technologies that streamline processes, lower costs and deliver consistent, reliable results.

According to the German group, its products are currently being used by scientists around the world to develop more than 50 vaccine candidates, more than 35 testing solutions and more than 20 monoclonal antibodies, plasma products and antivirals to combat the novel coronavirus.

Author: Dede Williams, Freelance Journalist