Sherlock Biosciences will team up with Danaher’s Integrated DNA Technologies division to scale up the manufacturing of its CRISPR-based coronavirus diagnostic test in the coming weeks.
The rapid test is designed to provide a COVID-19 result in about an hour, without specialized laboratory equipment. It received an emergency authorization from the FDA in early May as the first diagnostic to employ the gene-editing technology.
The two companies plan to launch with 30,000 test kits by the end of this month. IDT will supply the Cas13a enzymes and template RNA needed to match up with the specific genomic material of the novel coronavirus, with CRISPR’s gene-snipping action producing a detectable positive result.
“Given the severity and scale of the COVID-19 pandemic, it is imperative to increase and improve upon existing diagnostic solutions,” Sherlock’s co-founder, president and CEO, Rahul Dhanda, said in a statement.
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“We are pleased to partner with IDT, a leading comprehensive genomics solution provider,” Dhanda added. “They have already been leading the charge in large-scale manufacturing of key components for the CDC EUA testing protocol to meet the demands of this global pandemic, and this is another avenue in which they are supporting testing needs.”
“Through this strategic partnership, we will be able to scale production as needed to satisfy the demand for increased testing volumes, which should allow laboratory technicians to run tests at a higher throughput and provide results rapidly to improve patient care,” he said. The financial terms of the deal have not been disclosed.
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The former Fierce 15 winner’s test is still authorized to be used within high-complexity laboratories—instead of at the point-of-care or in the field—for processing nasal and oral swabs or lavage specimens collected from deeper in the lungs.