Abbott has become the next major diagnostics company to receive an Emergency Use Authorization from the US FDA for a COVID-19 test.
The US Food and Drug Administration has issued Emergency Use Authorization (EUA) to Abbott Laboratories Inc. for a COVID-19 test, the company announced 18 March.
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Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?
Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?
The Cologuard Plus test has a sensitivity of 95% and a specificity of 94% for the detection of colorectal cancer; “unmatched accuracy,” according to Exact Sciences.
Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?
The Cologuard Plus test has a sensitivity of 95% and a specificity of 94% for the detection of colorectal cancer; “unmatched accuracy,” according to Exact Sciences.
