Burlington, Massachusetts, October 29, 2020 — MilliporeSigma today announced a collaboration with Mammoth Biosciences Inc., of South San Francisco, California, for the development, scale-up and commercial production of Mammoth’s CRISPR-based SARS CoV-2 diagnostic test. Mammoth’s high-throughput systems will be compatible with both nasal swab and saliva samples and are targeting approximately 1,500 tests per 8-hour shift with minimal user interaction. Mammoth Biosciences plans to submit the assay for FDA Emergency Use Authorization later this year.
“This collaboration will allow us to help Mammoth with the development and production of their new SARS-CoV-2 test, which, once approved by the FDA, will increase testing capacity here in the U.S. at the scale needed to combat this pandemic,” said Jean-Charles Wirth, head of Applied Solutions at MilliporeSigma. “MilliporeSigma is helping to advance the future of testing at scale. This is an important step in detecting Covid-19 quickly.”
MilliporeSigma will serve as the contract manufacturer of the DETECTR BOOST™ SARS-CoV-2 Reagent Kit, which will use standard, automated liquid handling equipment to allow rapid processing of patient samples. With this new test, Clinical Laboratory Improvement Amendments labs in the U.S. will be able to significantly improve capacity to regularly perform testing. According to Mammoth, the new test is 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.
“Leveraging the proven manufacturing and product leadership of MilliporeSigma is critical to Mammoth delivering a CRISPR-based diagnostic solution to labs,” said Janice Chen, Ph.D., co-founder and chief technology officer of Mammoth Biosciences. “We have the opportunity to make a tremendous positive impact on the pandemic by enabling the further scale-up of our nation's testing capacity.”
Mammoth recently secured funding from the National Institute of Health’s RADx program to scale its CRISPR-based testing workflow.
MilliporeSigma’s Applied Solutions business unit offers a broad range of products and services for clinical and diagnostic testing laboratories as well as the food and beverage industry. It provides technologies that streamline processes, lower costs and deliver consistent, reliable results. The production will take place at MilliporeSigma’s Life Science Center in St. Louis, Missouri.
MilliporeSigma is committed to the fight against Covid-19. The company’s products are 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 virus.Follow MilliporeSigma on Twitter @MilliporeSigma, on Facebook @MilliporeSigma and on LinkedIn.
About the Life Science Business of Merck KGaA, Darmstadt, Germany
The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has some 22,000 employees and 59 manufacturing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services.
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany generated sales of €16.2 billion in 66 countries.
The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck, KGaA, Darmstadt, Germany, visit www.emdgroup.com.