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The EUA is the fifth in less than a week from the FDA for assays to detect SARS-CoV-2 as testing capacity in the US continues to ramp up.
BioReference's Novel Coronavirus COVID-19 test was announced last week, and the company committed to testing 5,000 New Yorkers per day.
Hologic and LabCorp became the third and fourth commercial test makers to receive EUA designation for assays to detect the coronavirus that causes COVID-19.
Labs are using specific protocols to mitigate the effects of biotin, a vitamin supplement that can interfere with test results.
A pathologists' group has pointed out that the bill covers only EUA tests, and patients receiving tests with pending regulatory status may receive surprise bills.
The test, authorized March 13, runs on the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument and targets three regions of the SARS-CoV-2 genome.
The test is the third to receive EUA, following tests from the CDC and New York state, and it runs on Roche's Cobas 6800 and 8800 systems.
Firms like LabCorp, Quest, and BioReference have launched tests but a lack of clarity around demand presents challenges for assessing what capacity is needed.
The partners' "COVID-19 task force" will invest in ePlex molecular testing platforms from GenMark Diagnostics to quadruple UCSF's testing capacity.
Directing lab-developed tests through the emergency use authorization process has brought to light reagent supply shortages and other hurdles.
Public Health England has developed a test for the virus, and enhanced laboratories are helping the health service as it plans on running 10,000 tests per day.
The kits have been validated at the US Centers for Disease Control and Prevention and the firm says 625 kits are now ready to ship.
The Department of Health and Human Services selected the diagnostic test for development support through a streamlined process called an easy broad agency announcement.
Hologic said laboratories may leverage the random-access and open-access capabilities of its Panther Fusion system to broaden screening for the novel coronavirus.
LabCorp's test is being made available pursuant to FDA guidance that allows high-complexity, CLIA-certified labs to perform their own tests for SARS-CoV-2.
The bill, which was introduced in the House and Senate, would resolve longstanding questions around the FDA's authority to regulate laboratory-developed tests.
The researchers are studying use of pharmacy testing to monitor hypertension and cholesterol as well as for detecting and managing various infectious diseases.
FDA officials said at ACLA's annual meeting that the agency's efforts to balance rapid test access with safety during the coronavirus crisis carries lessons for the oversight of all tests.
The firm looks to win new customers among US providers while also partnering with IVD companies to embed its lab data analysis tools in their instruments.
The agency issued guidance noting that labs can test only the most challenging sample type and can use inactivated virus spiked into negative samples.