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regulatory guidance

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.

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The agency issued draft guidance on minimal residual disease as a biomarker and finalized another guidance on developing drugs with pan-cancer indications.

An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.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

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Forensic genetic firm Verogen has bought the genetic genealogy site GEDmatch.

Researchers have 3D-printed plastic bunnies that encase the information needed to make more such bunnies in DNA, according to Discover magazine.

Dan Rather, the former CBS Evening News anchor and executive producer of a new documentary, writes at the Guardian that everyone needs to know about CRISPR.

In PNAS this week: analysis of FOXA1 upregulation in ER-positive breast cancer, gene editing to correct recessive dystrophic epidermolysis bullosa, and more.