consumer genomics

Scientist working in the lab at Helix. Photo courtesy of Helix. 

By Laura Lovett June 15, 2018
In the last few years consumer genomics has grown in both its offerings and legitimacy. The industry that was once best known for telling clients if they were Italian or Hungarian is now securing its foothold within the healthcare space.    Whether it is uniting women switched at birth 72-years prior or settling neighborly feuds, consumer genomics have caught the public’s interest. The highest...
By Jonah Comstock June 4, 2018
As of tomorrow, individual genetic risk tests are officially exempt from requiring 510(k) premarket approval, provided the company offering the test has gone through a one-time premarket review of its testing apparatus and at least one test. The notice, which will be officially published tomorrow in the Federal Registry, finalizes a guidance that was originally proposed in November 2017. "Today,...
By Jonah Comstock January 4, 2018
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...
By Laura Lovett November 28, 2017
Senator Chuck Schumer (D-New York) is warning consumers to think before they buy mail-order DNA testing services this holiday season.  Schumer cautions that these test kits put consumer privacy at risk because DNA firms could potentially sell personal and genetic information. Now Schumer is calling on the Federal Trade Commission to investigate and ensure that the privacy policies are clear,...
By Jonah Comstock November 7, 2017
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...
By Heather Mack May 31, 2017
London-based FitnessGenes, which creates personalized fitness and nutrition plans for individuals based on a the results of an at-home DNA testing kit, has raised $5 million. Sino-German High Tech Fund (SGHF), an investment fund comprised of China’s Donghai Securities and Germany’s Grunderfonds, led the round. FitnessGenes positions its product as a means of figuring out which specific diet plan...
By Heather Mack April 7, 2017
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...
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