Consumer gene testing company 23andMe is launching a large online study on the relationship between genetics and weight loss behaviors. Drawing volunteer subjects from its existing customers, the company will investigate three different weight loss strategies in a study that hopes to recruit 100,000 participants.
"This is to my knowledge the first example of a genome-wide association study for...
FDA Commissioner Scott Gottlieb announced today that the agency intends to make a major change to its regulatory process around direct-to-consumer genetic health risk (GHR) tests. Specifically, the agency is creating a framework that will allow companies to bypass premarket certification for individual tests once they submit to a one-time review of their processes, an approach reminiscent of the...
The Scripps Research Institute on Wednesday announced a new smartphone app that can calculate a user’s risk of heart disease.
Hospitals will want to keep an eye on the research study that Scripps conducts about the effectiveness of giving patients predictions concerning adverse health events and what impact that could have on influencing healthy behaviors and lifestyle changes.
Scripps MyGeneRank...
Questions raised about IBM Watson for Oncology. A new report from STAT suggests that IBM has been overpromising and underdelivering with the cancer treatment application of its artificial intelligence engine. The article points out a lack of independent, peer-reviewed studies validating the software, and charges that Watson "doesn’t create new knowledge and is artificially intelligent only in the...
Cloud-based healthcare services company PrescribeWellness is working with Coopharma, a Puerto Rican cooperative of community pharmacies. With PrescribeWellness’s offering, Coopharma will aim to increase medication adherence, patient loyalty and health.
“This partnership benefits our member pharmacies and all of their patients,” Heriberto Ortiz Martinez, executive director of Coopharma, said in a...
Personal genetics company 23andMe will be teaming up with the Milken Institute, a think tank, and pharmaceutical company Lundbeck to drive enrollment for a genetic study designed to grasp the underlying biology of major depressive and bipolar disorders.
The study will combine cognitive assessments with genetic data and survey responses to assess how genes influence brain processes -- such as...
OCR settles HIPAA complaint with CardioNet. CardioNet, one of the oldest companies in the mobile cardiac arrhythmia monitoring space, has agreed to pay the Office of Civil Rights $2.5 million and enter into a corrective action plan in the end result of a HIPAA breach investigation that's been going on since 2012. The judgment is significant, writes law firm Morgan Lewis in a blog post, because it...
In a true first, the Food and Drug Administration is allowing 23andMe to sell its direct-to-consumer genetic test kits that provide information about an individual’s risk to certain diseases such as Alzheimer’s or Parkinson’s disease.
23andMe’s $199 genetic tests are available with the FDA’s blessing nearly three and a half years after the agency first ordered 23andMe to immediately stop selling...
Toolbox Genomics, a company that will soon begin to offer actionable health insights based on customers' sequenced genomes, has raised a small round of seed funding, the company told MobiHealthNews. The exact amount of the funding was not disclosed. The company's product will launch in mid-February for $49, CEO Didier Perez told MobiHealthNews.
"Basically what we do is based on a user's own DNA...
More than a decade ago, when most people were still using not-so-smart mobile phones, the first human genome was sequenced. It cost $3 billion. In the time it took for smartphones to become the essential consumer technology, DNA sequencing rapidly evolved from a costly, uncommonly used process into a quick, reliable, relatively cheap and widely used predictive tool to give insight on disease risk...
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