Proposals from two HHS agencies look to encourage patient access to data and interoperability in research and clinical practice, including Sync for Genes.
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The agency issued draft guidance on minimal residual disease as a biomarker and finalized another guidance on developing drugs with pan-cancer indications.
An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.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 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.
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.
St. Jude Children's Research Hospital scientists have treated infants with X-linked severe combined immunodeficiency using gene therapy in an early phase study.
In Nature this week: a genomic analysis of the snailfish Pseudoliparis swirei, ancient DNA analysis gives insight into the introduction of farming to England, and more.
