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regulatory guidance

May 14, 2020

FDA Requiring Real Patient Samples for Emergency Use Authorization of COVID-19 MDx Tests

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

May 05, 2020

Needs to Work

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

Apr 13, 2020

FDA Releases Guidance Outlining Considerations for CDx Labeling for Oncology Drug Groups

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.

Mar 26, 2020

FDA Fleshes Out Emergency Guidance for Coronavirus Test Developers

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

Mar 20, 2020

Commercial Coronavirus Test Developers Tweak Timelines, EUA Plans in Light of Loosened FDA Guidance

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

Mar 16, 2020

FDA Dramatically Expands Enforcement Discretion to Speed COVID-19 Test Access

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

Mar 16, 2020

Coronavirus Testing Delays Yield New Oversight Bill, Shine Light on LDT Regulation Debate

The sponsors of the VALID Act say it's time to modernize outdated diagnostic regulations slowing down test access during a public health crisis.

Mar 05, 2020

Coronavirus Dx Emergency Use Authorizations Progressing Rapidly Despite Criticism

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

Mar 03, 2020

Integrated DNA Technologies Authorized Under CDC EUA to Provide SARS-CoV-2 Test Kits

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.

Oct 24, 2019

All of Us Program Working on IDE Submission to FDA, Weighing Long-Read Sequencing Techs

Premium

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.

Breaking News

The Scan

Preprints During Lockdown

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

ApoE and COVID-19

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.

Search for Genetic Clues to COVID-19 Severity

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.

PNAS Papers on Retinal Development, Adoptive T Cell Transfer, Blood Cell Differentiation

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

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