23andMe, a personal genome sequencing service company has been directed by the Food and Drug Administration (FDA) to desist from selling its genetic test kits to consumers as it hasn’t obtained marketing regulatory clearance from the governing body. The company’s DNA collection kit and Personal Genome Service (PGS) are classified under medical devices and it is mandatory to obtain FDAs approval before selling these to the customers.
23andMe was founded in 2006 by Anne Wojcicki, Paul Cusenza and Linda Avey to offer genetic testing services to individuals. The company has Google Inc. as its major investor along with other investment companies. 23andMe has been in the news for some time now along with other players who offer genetic testing services for gradually reducing its price from a whopping $1000 per test to an affordable $99, making it accessible to every individual. These services got more publicity after Hollywood heartthrb and hottie Angelina Jolie underwent preventative double mastectomy after discovering that she carried BRCA1 mutation that increases the likelihood of breast cancer.
These tests, where significant portions of genome are mapped to identify whether a person is susceptible to a number of diseases and disorders has received mixed responses. The relevance of these tests is up for discussion, with one side saying that these tests empowers individuals with information about themselves which can be used to take preventative measures. While, the other side is sceptical and argues about the relevance, degree of accuracy and the statistical probability of the disease actually manifesting in those testing positive for genes that make them susceptible to certain diseases, not to mention the chances of false positives. FDA’s objection and its directive stopping 23andMe from selling its Saliva Collection Kits and Personal Genome Service is based along the same lines. The administrative body is concerned about unregulated testing and the effect of inaccurate results on public health.
FDA wants to ensure that the test, capable of assessing the risk of cancer, heart diseases and other medical conditions works as claimed. FDA wants assurance from 23andMe that they have analytically or clinically validated the PGS for its intended uses and obtain necessary regulatory clearances in compliance with the 2010 decision for companies selling services that claim to evaluate disease risk directly to customers. 23andMe is said to be working on addressing these concerns raised by FDA.