• So 23andMe is now a drug company, apparently They’ve hired a longtime Genentech R&D chief to serve as Chief Scientific Officer/head of therapeutics. His charge is, more or less, turning data into drugs. As Forbes’ Matt Herper points out, 23andMe has a $60 million partnership with Genentech around Parkinson’s data – but if they were to develop a Parkinson’s drug themselves based on that data, they’d be looking at many billions. Here’s the press release.
  • This news comes just weeks after FDA approved a 23andMe home use test for a specific genetic variation – the first such test from the company granted authorization – and designated such tests exempt from premarketing approval. The test in question screens for a mutation that causes Bloom disease, which predisposes carriers to cancer.
  • Apple’s big Apple Watch reveal was a bit ho-hum on the healthcare front – except for their announcement of ResearchKit, which lets medical researchers create diagnostic apps and enables iPhone users to enroll in clinical trials or share their data with researchers. Apple announced five apps that have been created using the platform, including one for Parkinson’s patients – a collaboration between the Michael J. Fox Foundation and Sage Bionetworks – that can track hand and vocal tremors or an unsteady gait. Already, the app has thousands of users, and thousands more signed up for a cardiovascular study within 24 hours of the rollout. Of course, privacy is a concern, and medical ethicists and watchdogs are worried about other issues, such as informed consent and study supervision. Regardless, seems safe to say that this is a pretty revolutionary development in medical research.
  • Incidentally, if you want to get down in the weeds on the topic of anonymity and genetic testing, take a look at this.
  • Last week, the Supreme Court heard a case that could effectively destroy the subsidized insurance part of the ACA, which could render something like 10 million people (or more) uninsured and throw the whole healthcare system into chaos, over what is effectively a typo in the legislation (or, if you prefer, profound Constitutional questions over federal coercion of state governments and the Court’s latitude to interpret legislative intent, etc.). Seems like pretty much even odds whether or not the Court’s conservative wing will prevail and torpedo the federal insurance exchange. We should know in June, when the Court issues its decision. Either way, the shift to outcomes-oriented reimbursement is here to stay.
  • FDA approved its first biosimilar – a copycat version of Amgen’s chemo treatment Neupogen from Novartis, dubbed Zarxio – on Friday. To date, a number biosimilars have been approved in Europe, which established an approvals process for the therapies long before the US did, and Zarxio is one of them, which helped grease the skids for its approval in the US. Here’s a good general backgrounder on the story.
  • The nonprofit Health Care Cost Institute has launched a Castlight-esque cost transparency tool, Guroo, that draws on claims data from four big insurers to give pricing information for 70 services across most of the country.

 

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