IGMPI India



DNA testing company positive about their business even after FDA warning

Last month, 23 and Me, a DNA testing company received a warning letter from the USFDA and was ordered to stop selling its saliva testing kit due to issues with clinical validity of their test results. The company debated about its test results and finally, agreed to the FDA notice.
The company agreed to stop offering health results to those customers purchasing the saliva test after 22nd November. However, information about ancestry and raw data was still made available to these customers. The company was involved in providing health results and detailing the risks of 254 health conditions, thereby giving health related advice to its customers. FDA was concerned that false negative or false positive test results could lead to unnecessary medical interventions or confusion.

However, the company remains positive about its data and proof regarding the health tests and test results. The company announced that it aims at resolving FDA issues and getting back to business at the earliest. It states that getting clearance for such concerns takes time and the company would do the necessary things to be able to start selling the saliva kits again.