regulatory guidance 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 Premium 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. FDA Will No Longer Review EUA Submissions for SARS-CoV-2 Lab-Developed Tests The agency provided the update on Wednesday in its weekly virtual town hall and on its FAQ page. Sep 3, 2020 International Commission Deems Germline Genome Editing Not Yet Safe in Human Embryos Premium Aug 28, 2020 Stakeholders Scramble to Predict Impact of HHS Move Limiting FDA Ability to Regulate LDTs Premium 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 Premium 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 Premium 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 Premium Dec 21, 2018 As Dog Genetic Testing Booms, Calls for Regulation Grow Louder Premium Dec 19, 2018 FDA CDx Class Labeling Draft Guidance May Ease Patient Access, Spur Competition Among Test Makers Premium Load More Breaking News At NSGC, Genetic Counselors Address Race-Based Medicine, Ways to Change New Products Posted to GenomeWeb: Becton Dickinson, Cosmos-ID, OncoDNA, More FDA Grants Emergency Use Authorization for Northeastern University SARS-CoV-2 Test FDA Revises SARS-CoV-2 Test Emergency Use Authorization Requirements to Account for Variants Geisinger Wins $5M NIH Grant to Develop Point-of-Care Genetic Diagnostic Tool Second Genome, Virginia Commonwealth University Partner on NASH Biomarker Discovery The Scan Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification In Science this week: a number of editorials and policy reports discuss advances in in human genomic research, and more. Booster for At-Risk The New York Times reports that the US Food and Drug Administration has authorized a third dose of the Pfizer-BioNTech SARS-CoV-2 vaccine for people 65 and older or at increased risk. Preprints OK to Mention Again Nature News reports the Australian Research Council has changed its new policy and now allows preprints to be cited in grant applications. Hundreds of Millions More to Share The US plans to purchase and donate 500 million additional SARS-CoV-2 vaccine doses, according to the Washington Post.