Just as the current season, consumer-grade gene sequencing seems to have ushered in the best spring in the past month.
On March 16, Mass Mutual (Massachusetts) signed an agreement with genomics firm Human Longevity (HLI) to allow employees and insurance customers to conduct a comprehensive analysis of their genetic data at preferential prices. . On Thursday (April 6), the genetic testing company 23andMe's Personal Genome Service for 10 disease risks, the Genetic Health Risk (GHR) test, became the first consumer-grade product approved by the FDA.
These two incidents seem to be sending a strong signal that, in addition to technology, the two most important business logics: the payer and the regulator are showing an olive branch at the consumer level.
23andMe: Keeping the clouds open to see the moon
For 23andMe, the April day is a blue sky.
At the end of 2013, at the request of the FDA, 23andMe was forced to suspend the provision of genetic testing services for new users. At the time, the FDA posted a warning letter on its website stating that 23andMe's service claims can help users prevent diseases such as diabetes and breast cancer, and most of the use of the service indicates that it belongs to the medical device category and requires FDA approval. This decision means that the FDA decided to classify disease risk predictions based on individual genome sequencing as medical devices.
At the time, 23 Wo's founder Anne Wojcicki was divorcing with her ex-husband, Google founder Sergey Brin. For a time, whether it is 23andMe, the former star company or Anne himself, it seems to have some bleak future.
Fortunately, after the bleak 2014, things started to turn around in 2015. In early 2015, the FDA approved 23andMe for the genetic disease, the genetic test of Bloom's syndrome, which opened the door to the 2013 ban. In the same year, the FDA approved a one-time approval of 23andme for genetic testing of 36 genetic diseases, including cystic fibrosis, sickle cell anemia, etc. Of course, the test content is still related mutations, not the risk of disease.
Just like the good luck when driving, the green light of an intersection followed by the passing of several intersections. On April 6, 23andMe received FDA approval to provide users with reports of genetic risks including 10 diseases including Parkinson's disease and Alzheimer's disease. Different from the 2015 approval, the genetic diseases with relatively clear causality are different, and many of these ten diseases are not genetic diseases in the traditional sense. This also means that the rigorous FDA has approved 23andMe's statistical analysis of disease risk. No wonder even Anne Wojcicki can't help but report on Twitter.
Anne Wojcicki, founder of 23andMe, thanked FDA for approval
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