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News items for the in vitro diagnostics industry for the week of March 23, 2020.
Such tests indicate whether a person had an immune response to the virus, which could aid infection tracking and identifying individuals with immunity.
BioReference's Novel Coronavirus COVID-19 test was announced last week, and the company committed to testing 5,000 New Yorkers per day.
In announcing a national emergency on Friday, Trump paraded out executives from the private sector as the administration tries to increase testing capacity
BioReference is also now accepting specimens for testing SARS-CoV-2 and expects to offer 5,000 tests a day at satellite testing sites next week.
Firms like LabCorp, Quest, and BioReference have launched tests but a lack of clarity around demand presents challenges for assessing what capacity is needed.
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.
Opko recorded $177.9 million in service revenues, $32 million in product revenues, and $14.4 million from licensing and the transfer of intellectual property revenues.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
The test will now be considered medically reasonable and necessary for patients over 45 with moderately elevated levels of prostate-specific antigen.