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regulatory guidance

The Division of Antiviral products has laid out nonbinding recommendations about the acceptable NGS platforms and the kinds of information it's looking for.

Proposals from two HHS agencies look to encourage patient access to data and interoperability in research and clinical practice, including Sync for Genes.

While canine genetic testing providers bemoan a lack of quality standards, they disagree on what specific rules labs should follow.

The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.

The agency issued draft guidance on minimal residual disease as a biomarker and finalized another guidance on developing drugs with pan-cancer indications.

An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.

The protocol could lead to greater regulatory harmonization in Europe, where every country has its own national legislation covering genetic testing.

The FDA said that pooled testing of donations using a screening test that it has licensed is a sufficient method for complying with its testing regulations.

Consent — and the right to withdraw it — underlies the EU's newly effective General Data Protection Regulation for researchers in Europe and beyond.

The agency finalized recommendations for developing and validating NGS tests, and proposed a submission process for investigational IVDs in cancer Rx trials.

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23andMe has a holiday popup shop at a mall and could open additional stores, Bloomberg reports.

By studying koalas and a retrovirus that infects them, researchers may have uncovered a new sort of 'immune response' that occurs at the genomic level, Agence France Presse reports.

NPR reports that the first person in the US given a gene editing-based therapy for a genetic disorder is heading home.

In Science this week: ancient genomes reveal social inequality within individual households, new method for quantifying genetic variation in gene dosage, and more.