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The FDA has granted Emergency Use Authorization for two commercially developed coronavirus tests– providing fast results within 4 hours.

Mar 17, 2020 | News

Shortly after the FDA granted an Emergency Use Authorization to its first commercially developed coronavirus test—developed by Roche for use on its high-throughput cobas system—the agency did the same for Thermo Fisher Scientific’s diagnostic.

The green lights for both tests were granted within 24 hours of receiving their applications, the FDA said. This now allows for the immediate use of Thermo Fisher’s TaqPath COVID-19 Combo Kit on its Applied Biosystems 7500 Fast Dx real-time PCR hardware in certain high-complexity laboratories nationwide.

Thermo Fisher said the test, designed to detect the specific nucleic acids from the virus SARS-CoV-2, can provide results within four hours, including the time needed to prepare the sample and perform the analysis.

“The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Thermo Fisher’s chairman, president and CEO, Marc Casper. “In partnership with the FDA and regulatory authorities around the world, we are committed to expanding the availability of diagnostic testing to prevent the spread of this disease.”

The FDA’s authorizations for Thermo Fisher and Roche’s tests allow them to be used in the clinic without a full agency approval during a public health emergency, which was first declared Jan. 31.

Meanwhile, Thermo Fisher’s latest M&A quarry—Dutch diagnostics outfit Qiagen—recently received a funding boost from the U.S. government to develop its own coronavirus test. Earlier this month, Thermo Fisher announced a $11.5 billion deal to acquire Qiagen following months of a semi-public back and forth.

The U.S. Biomedical Advanced Research and Development Authority, known as BARDA, provided Qiagen with $598,000 to accelerate the development of its cartridge-based  QIAstat-Dx test kit to help differentiate the novel coronavirus from 21 other serious respiratory infections. The company said the testing panel could provide results in as little as one hour.

“We have scaled up production to respond to the rapid spread of COVID-19, moving to 24-hour, seven-day-a-week operations at two key sites, investing to expand capacity by 70% and adding staff,” said interim CEO Thierry Bernard, who also heads the company’s molecular diagnostics business area.

“Our top priority is producing the QIAamp and EZ1 sample technologies recommended in the U.S. Centers for Disease Control guidelines for testing, as well as the new QIAstat-Dx cartridges,” Bernard said. “We are working closely with laboratories, hospitals and other customers around the world to assess their flexibility, timing and quantity needs.”

Source: Fierce Biotech

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