regulatory guidance

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The agency issued draft guidance on minimal residual disease as a biomarker and finalized another guidance on developing drugs with pan-cancer indications.

An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.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

Research teams and commercial firms are increasingly using genome editing to address farm animal health and welfare, from viral resistance to physical traits.

In two documents FDA discusses the development of drugs for molecular indications and investigational device exemption requirements for IVDs in drug trials.

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John Mendelsohn, a former president of the University of Texas MD Anderson Cancer Center, has died, the New York Times reports.

Chinese state news agency Xinhua reports that a preliminary investigation has found He Jiankui performed his gene-editing work illegally.

Identical twins receive different estimates of ancestry from the same direct-to-consumer genetic testing firms, CBC reports.

In PNAS this week: chromosomal features of maize, adaptations in the vinous-throated parrotbill, and more.