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NEW YORK – In a surprise move, the US Department of Health and Human Services said on Wednesday that it had determined the Food and Drug Administration would not require premarket review of laboratory-developed tests without notice-and-comment rulemaking.

The announcement, which took many in the lab industry aback, appeared to resolve for now the role of the FDA in regulating LDTs, an issue that has hung over the laboratory business for almost three decades.

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The Lancet has made changes to its peer-review process in response to its recent retraction of a COVID-19-related paper, Science reports.

The New York Times reports that a series of emails show how Department of Health and Human Services officials sought to silence the Centers for Disease Control and Prevention.

A new initiative aims to move Australia's genome sequencing labs onto one system, the Sydney Morning Herald reports.

In PLOS this week: recessive mutation tied to early-onset dilated cardiomyopathy, epigenetic analysis of lung adenocarcinoma, and more.

Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.