Silicon Valley sensation 23andMe, a genetic testing company that used to provide ancestry and health related data to consumers, is set to resume to provide this health related trait information again. Back in November of 2013, the Food and Drug Administration had stopped them from providing the health data due to potential false positives, so now two years later they are gearing up to sell their new test kits.
After the FDA stopped them, the company was able to continue to offer ancestry information based on genetic data only, however 23andMe was not allowed to provide any data on non-medical traits like the color of a person’s eye, the composition of the earwax, or whether a person could have a intolerance to lactose.
23andMe announced in October 2015 that it will be providing clients with health information subject to approval by the F.D.A. The company, which is known to be a game-changer with values based on boundless possibilities; this is set to diversify its portfolio to a drug developer from being only a testing service.
It hopes to bring more subscriptions on board, given their service of informing people about the risk of passing inherited diseases to their children. The Mountain View, California-based company has changed its website as well in an effort to simplify the genetic information and announce the new price for its service which is $199 from the previous price of $99.
Anne Wojcicki, co-founder and chief executive of 23andMe, said during an interview with the NY Times, we took advantage of the two years break from the market to improve our services.
Initially, 23andMe used DNA found in saliva samples to test if consumers were at risk of getting various diseases. Previously, the company was famous for its spit parties that were frequented by celebrities and the message that encouraged users to get their genetic information without involving doctors or regulatory agencies. The fact that Ms. Wojcicki was married to Google co-founder Sergey Brin and the tech giant had invested in the company also helped their cause.
The tides were to change in November 2013 when the F.D.A. required the company first to get their approval. This would only happen after they satisfied the regulators that they gave their clients accurate results. This impediment was similar to what is happening to Theranoss, another medical testing firm in Silicon Valley that is run by businesses woman Elizabeth Holmes.
Last month, The Wall Street Journal questioned the accuracy of the Theranoss testing services in some articles (The medical testing firm insists that their accusers are wrong), and now the F.D.A has asked the company to stop drawing blood from its clients’ fingers until the regulators approve of their device.
Bouncing back, 23andMe has a new limited test kit, compared to the original one, that will present health-related service information about carrier status. The new service entails checking if people have any genetic mutations that could cause their offspring to get a particular disease, assuming the other parent has the same gene mutation, making their child get mutated genes from both sides.
The company will be offering information on thirty six diseases among them Tay-Sachs, sickle cell anemia and cystic fibrosis. It is not clear if the information which potential parents will find interesting, and in any way compelling as other doctors carry out other carrier tests from different laboratories.
According to Ms. Wojcicki, 23andMe is still hopeful of approval from F.D.A and instead of working against the system the firm has since changed its operations to work from within the prevailing system with a view to giving the consumer some sense of ownership and voice in the current system. According to Ms. Wojcicki, the company lost half of its new sign-ups when they were working to get approval.
Despite all this, 23andme still offered ancestry information. The business continued growing and this year it crossed the one million users mark. The growth was in sharp contrast to the five hundred thousand users of their services when the F.D.A gave the new requirements. Ms. Wojcicki, however, refused to reveal the current number of users.
Most customers do not have a problem with the company using their information for medical research with some offering more information including the disease from which they are suffering. Household names such as Genentech and Pfizer currently pay the company for the data they have collected to develop drugs. 23andMe decided to start researching and developing drugs in May. Former Genentech point man Richard Scheller is spearheading the effort.
Other genomics companies such as DeCode and Celera Genomics tried developing drugs as well. Clearly, it is more profitable for companies to develop drugs than sell genetic data. A point to note however is, drugs are more costly and riskier to develop with many businesses suffering failures in earlier attempts.
Ms. Wojcicki, stated in that interview, that they were hopeful that previous failures would provide a learning experience for the company. In her opinion, pharmaceutical companies prefer licensing experimental compounds to obtain raw data. 23andMe has since managed to acquire $241 million from the investor.
Fidelity Management & Research has invested $115 million out of the total investment. Ms. Wojcicki was emphatic that the company is yet to make any profits and with the investment being channeled towards the development of drugs; it might not be profitable in the immediate future.