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Caputo on Leave

Michael Caputo, the top Department of Health and Human Service spokesperson, is taking a leave of absence, CNN says.

Review Sought

Politico reports that political appointees are interfering with what appears in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Reports.

The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.

The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.

CNN reports the change in the US Centers for Disease Control and Prevention's coronavirus testing guidelines was in response to administration pressure.

Shift in Regulation

An announcement last week says laboratory-developed tests do not need to undergo premarket review by FDA.

While observers are still sorting out the implications of the surprise announcement, it will likely limit the agency's role in regulating LDTs.

The action will immediately allow labs to offer SARS-CoV-2 LDTs without requiring EUA, and make it voluntary for labs to take LDTs through FDA premarket review.

Most Rejected

According to ScienceInsider, a US ethics board has rejected most of the applications it reviewed for using human fetal cells in research.

The commercial labs will also receive testing equipment from Beckman Coulter Life Sciences and Thermo Fisher Scientific including RT-PCR instrumentation.

Pages

Politico reports that the NYPD DNA database has grown since it announced it would be removing profiles from it.

Forbes reports that a structural biology lab at Oxford University studying the coronavirus was hacked.

Science reports that a Dutch research funding agency is combating a ransomware attack.

In Science this week: set of 64 haplotype assemblies from 32 individuals, and more.