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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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Russia says its candidate SARS-CoV-2 vaccine has a very high efficacy rate in an initial analysis of clinical trial data, according to the Financial Times.

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