Bio Saga Blog - A Chronicle of Life Sciences & Informatics

The tables turn, it's 23andMe's turn to send a letter to FDA... Continuing the story  Reading Between Lines   slapped with cease and desist  letters . Direct-to-consumer genomics firm 23andMe has sent a letter to the heads of the US Food and Drug Administration and National Institutes of Health asking for a collaborative effort to develop guidelines for genetic testing. The firm  posted the letter  that it sent to FDA Commissioner Margaret Hamburg and NIH Director Francis Collins on its blog, The Spittoon, last night. 23andMe is one of several companies to be targeted recently by FDA, which  sent letters to several firms  saying that it believes the firms are selling unapproved diagnostic devices. The other firms that received letters were Knome, 23andMe, Decode Genetics, Navigenics, and Illumina, the last of which was cited for providing the tools that are used to provide genetic information to certain of the DTC genomics' customers. In the letter...

Previous blogging on the topic of GINA GINA Aftermath - Consumers Still Wary of Genetic Tests and in the series of blogs closing following the personal genomics industry scene . Now here is some thing very interesting and very vital that is about education the common man about GINA. Johns Hopkins University’s Genetics and Public Policy Center has launched an educational effort aimed at informing the public of how their genetic data can and cannot be used under the recently enacted Genetic Information Nondiscrimination Act. As part of its so-called “Project GINA,” the GPPC plans “to disseminate information” about the legislation to healthcare stakeholders and the general public, GPPC Law and Policy Director Susannah Baruch told last week. As part of its plan, the GPPC will launch a web site describing and explaining the federal law that bars health insurers and employers from discriminating based on genetic data. The website, slated to launch in September, will outline what protection...