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Quest Diagnostics announced Thursday that it is launching its own test to detect COVID-19, saying it will be able to receive specimens, collected in appropriate healthcare settings, and begin to provide testing to patients in the US as of March 9. Also on Thursday, Laboratory Corporation of America said it is making its COVID-19 NAA test available on March 5 for ordering by physicians or other authorised healthcare providers anywhere in the US. Meanwhile, OPKO Health stated that it will also offer a test for the novel coronavirus, with screening across the country to be provided starting next week.
Steve Rusckowski, chief executive at Quest, applauded the FDA "for providing the flexibility for innovative, quality laboratory-developed tests to be brought to patients and providers quickly to advance effective response to the coronavirus outbreak." Previously, only testing kits developed by the US Centers for Disease Control and Prevention (CDC), many of which were found to be defective, could be used in public health laboratories.
According to Quest, its test service will be provided as a laboratory-developed test, pending FDA review under emergency-use authorisation, which the company will submit within 15 days of clinical testing. It noted that the test is a molecular-based assay that detects viral RNA in respiratory specimens.
Meanwhile, LabCorp said its test, a qualitative assay using PCR technology, has been validated for use with respiratory samples, including nasopharyngeal or oropharyngeal aspirates, washes or swabs, and broncheoalveolar lavage. The company noted that the FDA's independent review of the validation is pending, adding it is also pursuing an emergency-use authorisation for the test.
Earlier this month, the FDA unveiled a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the US. Former FDA Commissioner Scott Gottlieb has also called on Quest, LabCorp and others to step up testing for coronavirus in the US amid the outbreak.
Meanwhile, LabCorp said Wednesday that it would launch its COVID-19 test service at the end of this week at the earliest, and make it available nationwide next week. Evercore ISI analysts expect the tests developed by Quest and LabCorp to be priced around $45 to $50, comparable to tests for influenza. Separately, Co-Diagnostics said it was seeing a surge in demand for its coronavirus test kits after the FDA policy change.
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