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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 government payor is interested in public input on the evidence underlying the blood-based PCR test.
Labs can deploy the test kit omitting the pan-SARS component, and new kits that are specific only to SARS-CoV-2 are being manufactured.
The agency said all tests for the virus must pass through its EUA process, but noted a test could be authorized under a single EUA for use in multiple labs.
A handful of rapid 2019-nCoV assays are in the works which could help triage patients more effectively and avoid unnecessary quarantines.
The Centers for Disease Control and Prevention says one of the test reagents will likely need to be remanufactured in its labs.
The EUA allows the test to be used at all CDC-qualified labs in the US on patients who meet CDC criteria for testing for the coronavirus.
The DNBSEQ-T7 ultra-high-throughput sequencer, metagenomic sequencing kit for coronaviruses, and 2019-nCoV RT-qPCR kit have received authorization from China's NMPA.
While it continues to seek investments, the firm is also making preparations for an initial public offering on the Nasdaq First North exchange.
Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.