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regulatory guidance

FDA, HHS Update COVID-19 Test Emergency Use Authorization Policies

The FDA said it intends to focus on specific EUA requests, while HHS withdrew a policy directing FDA not to enforce premarket review requirements for LDTs.

FDA Issues New Guidance on SARS-CoV-2 Variants for Test Developers

The agency cautioned test companies that the presence of mutations in the virus could lead to false negative results.

FDA Issues Alert About Potential False Negative Test Results From SARS-CoV-2 Mutations

The agency identified three tests potentially impacted by known mutations, and said it will continue to monitor authorized assays.

SARS-CoV-2 Mutations Present Unexpected Opportunities, Challenges for MDx Developers
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Some tests that detect multiple SARS-CoV-2 genes are serendipitously signaling new viral variants while still effectively detecting infections.

FDA Relaxes Rules for Flu, RSV Molecular Tests During Coronavirus Health Emergency

The new guidance allows developers to use other transport media and sample types without first obtaining 510(k) clearance.

Oct 7, 2020

FDA Will No Longer Review EUA Submissions for SARS-CoV-2 Lab-Developed Tests

Sep 3, 2020

International Commission Deems Germline Genome Editing Not Yet Safe in Human Embryos
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Aug 28, 2020

Stakeholders Scramble to Predict Impact of HHS Move Limiting FDA Ability to Regulate LDTs
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Jul 30, 2020

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

Jul 7, 2020

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

Jun 19, 2020

Improved Pool Testing Methods Could Enable COVID-19 Screening as Pandemic Continues
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Jun 17, 2020

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

May 29, 2020

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

May 14, 2020

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

Apr 13, 2020

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

Mar 26, 2020

FDA Fleshes Out Emergency Guidance for Coronavirus Test Developers

Mar 20, 2020

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

Mar 17, 2020

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

Mar 16, 2020

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

Mar 5, 2020

Coronavirus Dx Emergency Use Authorizations Progressing Rapidly Despite Criticism

Mar 3, 2020

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

Oct 24, 2019

All of Us Program Working on IDE Submission to FDA, Weighing Long-Read Sequencing Techs
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Jul 19, 2019

FDA Offers Guidance on Submitting NGS Data in Support of Antiviral Drugs

Mar 1, 2019

'Information Blocking' Plan Seeks to Free Data for Precision Medicine
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Dec 21, 2018

As Dog Genetic Testing Booms, Calls for Regulation Grow Louder
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Breaking News
The Scan

Genetic Risk Factors for Hypertension Can Help Identify Those at Risk for Cardiovascular Disease

Genetically predicted high blood pressure risk is also associated with increased cardiovascular disease risk, a new JAMA Cardiology study says.

Circulating Tumor DNA Linked to Post-Treatment Relapse in Breast Cancer

Post-treatment detection of circulating tumor DNA may identify breast cancer patients who are more likely to relapse, a new JCO Precision Oncology study finds.

Genetics Influence Level of Depression Tied to Trauma Exposure, Study Finds

Researchers examine the interplay of trauma, genetics, and major depressive disorder in JAMA Psychiatry.

UCLA Team Reports Cost-Effective Liquid Biopsy Approach for Cancer Detection

The researchers report in Nature Communications that their liquid biopsy approach has high specificity in detecting all- and early-stage cancers.