NEW YORK (GenomeWeb) – The US Food and Drug Administration has sent a letter to Sure Genomics asking why the company is marketing its SureDNA saliva sample kit without the agency’s clearance. “We have conducted a review of our files, and have been unable to identify any FDA clearance number for the SureDNA test,” the agency wrote in a Feb. 16 letter to Sure Genomics CEO Warren Little. “We request that you provide us with the FDA clearance number for the SureDNA test. If you do not believe that you are required to obtain FDA clearance for the SureDNA test, please provide us with the basis of that determination.”
