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regulatory guidance

With the US now awash in positive samples, assay developers seeking authorization will no longer be allowed to use contrived samples.

Needs to Work

With new guidance, the US Food and Drug Administration tightens its oversight of SARS-CoV-2 antibody tests.

The agency recognized that having some companion tests approved for a few but not all cancer drugs with the same molecularly defined indication is not optimal for patient care.

The agency provided an overview of its policies regarding COVID-19 test regulations, as well as additional color and clarification, in a webinar.

Test makers are preparing to ramp up production of new SARS-CoV-2 assays and designated testing systems in anticipation of increased demand.

In a guidance, the agency described expanded policies that will enable manufacturers, local labs, and others to quickly deploy coronavirus testing. 

The sponsors of the VALID Act say it's time to modernize outdated diagnostic regulations slowing down test access during a public health crisis.  

SARS-CoV-2 viral material is available for test validation, and the FDA is conducting a rolling review process with an abbreviated submission template.

According to a US Food and Drug Administration webinar yesterday, a lot of IDT test kits has been qualified by CDC and is authorized for purchase.

The program will likely only generate sequencing data, not genotyping array data, for returning health-related results to reduce the complexity associated with two platforms.

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New analyses indicate female researchers are publishing less during the coronavirus pandemic than male researchers, according to Nature News.

A study suggests people with the ApoE e4 genotype may be more likely to have severe COVID-19 than those with other genotypes, the Guardian says.

Direct-to-consumer genetic testing companies are searching for a genetic reason for why some people, but not others, become gravely ill with COVID-19, the Detroit Free Press reports.

In PNAS this week: forward genetics-base analysis of retinal development, interactions of T cell receptors with neoantigens in colorectal cancer, and more.