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In announcing a national emergency on Friday, Trump paraded out executives from the private sector as the administration tries to increase testing capacity
According to the recall, initiated on Jan. 28, a glitch in the software’s data reporting to LIM systems could cause false-negative results from PCR assays running on the instrument.
The agency will reimburse at about $35.91 per test for CDC assays and about $51.31 per test for non-CDC assays.
Under the NYSDOH's approach, labs need to provide validation data within 15 days of starting to test instead of having to pursue an EUA with the FDA.
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.
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.
Fulgent and its China-based joint venture are working on a clinical NGS-based test that it says will have better sensitivity than RT-PCR-based kits.
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.
SARS-CoV-2 viral material is available for test validation, and the FDA is conducting a rolling review process with an abbreviated submission template.
Regulators told the lab industry that they can continue to offer PGx lab tests without FDA approval if they make evidence-based claims.
Master's and doctoral students in the UK call on funding groups to extend their grants for the duration of the disruption caused by the COVID-19 outbreak, the Guardian reports.
Squid can make edits to their RNA within the cytoplasm of their axons, Science News reports.
The Chan Zuckerberg Initiative is putting $25 million toward COVID-19 treatment research, according to the Verge.
In Science this week: researchers engineer version of Cas9 that is nearly PAM-less, and more.