DNA Test Maker Hit With Nasty Warning Letter

DNA Test Maker Hit With Nasty Warning Letter

November 25th, 2013 // 4:52 pm @

FDA last week ordered the DNA testing firm 23andMe to cease selling its OTC generic DNA test, stating that it is being sold without FDA approval to diagnose diseases.

The DNA test, which has been heavily marketed in recent months, has a kit to sample your saliva, and the firm promises that it will offer health care advice. On its website, it states that based upon your DNA results, the company will provide you with health recommendations that are personalized.

FDA sent a particularly nasty warning letter to the firm. In it, FDA stated that it has tried to work with the firm to get it to provide clinical evidence that the test can do what it claims with any accuracy.

The letter stated that because the 23andMe Saliva Collection Kit and Personal Genome Service does not have FDA clearance, it is clearly in violation of the FD&C Act. Thus, the company must stop the marketing of the product immediately, until FDA provides marketing authorization.

The firm stated in a press release that it had received the FDA warning letter, and it notes that it has not yet met agency expectations for the timeline and communication regarding the product. It stated that it continues to work with FDA so that it will approve the product.

FDA states that the company is making promises that are not based upon clinical evidence. For example, it asserts that it can inform people what their risk of breast cancer is, and how sensitive they are to blood thinning drugs.

The letter stated that if the risk assessment for breast cancer is wrong, it could cause the person to undertake various cancer treatments, and a false negative could cause the patient to not recognize that they are at risk.

FDA states in the warning letter that it tried very heard to work with the firm to get the problems solved, and it met with the company 14 times. FDA says that it has told the company in person, in email and on the phone what it needs to do to get FDA approval for the product.

But the company appears to be stalling, and has yet to test the accuracy of its genetic tests.

FDA has been providing warnings to gene testing companies for three years, and told several that they must have FDA approval. But at this time, 23andMe is the only one that has been ordered to stop marketing its genetic test.

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