regulatory guidance Genetics & Genomics News

Jul 29, 2020

FDA Issues New Guidance for Non-Laboratory SARS-CoV-2 Diagnostic Tests, Pooled Testing

The agency has provided new guidance for tests that can be used outside of a lab setting, as well as updated its guidance on a number of other topics.

Jul 07, 2020

FDA Issues New Guidance for SARS-CoV-2 Pooled Sample Testing

The guidance suggests validating a five-sample pooling strategy, but notes that this may need to be adjusted depending on assay sensitivity and local prevalence.

Jun 19, 2020

Improved Pool Testing Methods Could Enable COVID-19 Screening as Pandemic Continues

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While new ways to carry out pool testing for SARS-CoV-2 abound, questions remain about sensitivity issues and the regulation of such tests.

Jun 17, 2020

FDA Provides Guidance on Pooled Samples, Asymptomatic Testing for SARS-CoV-2

The move is intended to increase testing for COVID-19 and may help conserve resources, which were a major problem during the height of the pandemic.

May 29, 2020

FDA Adds At-Home Self-Collection Template to SARS-CoV-2 Emergency Use Authorization Guidance

The template describes the data and information that should be submitted for EUA of collection kits or tests with a home self-collection component.

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.

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regulatory guidance

FDA Issues New Guidance for Non-Laboratory SARS-CoV-2 Diagnostic Tests, Pooled Testing

FDA Issues New Guidance for SARS-CoV-2 Pooled Sample Testing

Improved Pool Testing Methods Could Enable COVID-19 Screening as Pandemic Continues

FDA Provides Guidance on Pooled Samples, Asymptomatic Testing for SARS-CoV-2

FDA Adds At-Home Self-Collection Template to SARS-CoV-2 Emergency Use Authorization Guidance

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

Needs to Work

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

FDA Fleshes Out Emergency Guidance for Coronavirus Test Developers

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

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