Upon its inception, 23andMe quickly became known for using the sequenced DNA of its private clients to give them information on their health and ancestry. All the clients had to do was send samples of their saliva to the firm for analysis.
The company was allowed to sell the home test products with the sole intention of determining ancestry information. For example, using the information obtained from the tests, clients could learn whether or not they are direct descended from the Neanderthals. Also, know whether their DNA closely matches the DNA of people from other parts of the world (you can see an in-depth review of this part of their test here: http://MyFamilyDNATest.com/23AndMe ).
In 2013, however, the start-up got into trouble with the FDA (Food and Drug Administration) after it claimed that their main product was in violation of FDA rules and regulations as it hadn’t gotten approval from the agency. The FDA further noted that the home test product was used in the diagnosis, cure, and prevention of disease and hence approval from the agency was necessary.
Since its unfortunate run-in with the FDA, 23andMe has been working around the clock to get approval from the agency. Two years later, their efforts have paid off, though not as entirely as they would have wanted them to. The company gained approval to use the product to determine whether there is a risk of clients passing hereditary diseases on to their children.
Unfortunately, the company still does not have the approval to use the product to inform clients about the likelihood of contracting various diseases. According to the co-founder and CEO Anne Wojcicki, working hand in hand with the FDA has resulted in 23andMe becoming a better company.
In addition to that, the CEO is proud of the fact that they are at the forefront of direct-to-consumer genetic testing. She also believes that there is a lot for clients to learn from their chromosomes and the kit is meant to make this learning process easier and more direct.
Founded in 2006 and now approaching its 10th anniversary, the company now has a new and approved product that is meant to give clients a detailed report of at least 60 different traits that touch on health, ancestry, genetics and even personality. The report also delves into the carrier status of the clients.
Basically, this means that the kit will be used to point out the genetic mutations in the samples of DNA that could increase or decrease the possibility of any one of 36 genetic diseases being passed on to children. The kit initially cost $99 but following its relaunch, it will now cost $199.
It will also be available on the firm’s website which has also been improved to make it easier for people to comprehend the results of the tests taken. The website and its corresponding information will also be available to clients who had already used the kit even before the relaunch.
Aside from that, the company is also trying to popularize its Personal Genome Service. This is a program in which people participate in online surveys and fill out online questionnaires. The information obtained is then used in medical research.
For example, by using the information obtained from the Personal Genome Service, 23andMe has already been able to garner valuable data and statistics about the Parkinsons disease community.
Clearly, the company has come a long way since the FDA wrote to them raising their concern over the possibility of inaccurate results affecting public health negatively. In the letter, the FDA stressed that it was mainly concerned with the accuracy of the tests as inaccurate results whether positive or negative, would subsequently mislead customers/clients and cause further damage.
Following the recent approval from the FDA, there is no doubt that the genetic home test products are accurate enough to predict the carrier status of clients. How popular will the product be in the commercial market remains a mystery? The fact that there are already other genetic testing labs providing similar services only expands the opportunity for this to catch on by the general public.
With this in mind, the company is bound to continue with its efforts to get approval from the FDA to use the product to test for the possibility of clients contracting certain diseases. Whether they will succeed in getting this approval or how long it will be before the approval is given a thumbs up remains an unknown.
Update: April 6, 2017, FDA Press Release
23andMe has received approval from FDA to sell Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions.