23andMe Chief Executive Anne Wojcicki took to the company's blog following a warning from the Food and Drug Administration (FDA), which accused the genetic test makers of violating the Federal Food, Drug and Cosmetic Act.
Under attack is the company's Saliva Collection Kit and Personal Genome Service (PGS), designed to test for more than 250 health diseases and conditions.
In the post, Wojcicki underscored the company's commitment to its customer's health as well as to the FDA.
"23andMe was started in 2007 with the belief that consumers have the right to get access to their genetic information and that information can help them live healthier lives," Wojcicki wrote.
According to Wojcicki, the company "began our dialogue" with the FDA in 2008, with the company submitting its first application for FDA clearance in July 2012, followed by another submission at the end of August.
"We received feedback on those submissions and acknowledge that we are behind schedule with our responses," Wojcicki admitted, noting that a "relationship with the FDA remains critically important to 23andMe."
As part of its warning letter, the FDA expressed concern regarding the potentially life-threatening implications of false test results.
"Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses ... because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these," officials wrote. Possible fallout could include unnecessary chemotherapy and surgery as well as a false-negative hiding a real risk, they said.
Wojcicki responded, saying the company has labored "extensively" with lab partners in order to ensure accurate results.
"We stand behind the data that we return to customers -- but we recognize that the FDA needs to be convinced of the quality of our data as well."
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