The FDA awarded marketing authorization for a new Invitae test that uses next-generation sequencing to assess multiple genes to identify variants indicating a person’s predisposition for certain cancers. The regulatory action creates a new regulatory classification making Invitae’s test the predicate device for future cancer tests.
Standard newborn screening can detect dozens of inherited diseases, but genomics technology enables testing for hundreds of them. A North Carolina program evaluating the feasibility of bringing genomics to newborn screening is expanding with an initial goal of testing 5,000 babies in the next year.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Also, CTI BioPharma Corp said the U.S Food and Drug Administration has put a full clinical hold on the company's investigational new drug application for pacritinib.
Gene sequencing firm RainDance Technologies has withdrawn its $60M IPO, and researchers have found that omega-3 supplements might not have any affect on cognition for older people.
Personalized medicine will be expensive in these early days of pioneering and planning. But individual genomic testing is not going to be exorbitant forever – and the ROI is gonna be big, both in patient outcomes and dollars saved, said a panel of speakers at MedCity’s CONVERGE conference in Philadelphia. “Because pharmacogenomics is rooted in the pathobiology of disease, […]
Next-generation sequencing has reached the “lift-off stage,” according to Yuri Milner. He’s not just saying that; he’s putting his money behind it. The famed tech investor is joining Illumina (NASDAQ:ILMN) in committing to helping early-stage genomics companies as part of a new Mission Bay accelerator. Illumina said today it’s launching a program aimed at speeding […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.