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FDA Pulls DNA Testing Kit Claiming Safety and Marketing Issues

DNA

How a product is marketed can make or destroy profits–however, when medical devices such as DNA testing kits are the products marketing managers are targeting, things get trickier.

The Food and Drug Administration (FDA) exists in order to protect and inform the public about the details of medical drugs and devices, such as saliva test kits. 23andMe is a genetic testing company that had been selling the Personal Genome Device, a DIY saliva kit with high-tech qualities designed to help people make important health-related decisions (such as whether or not a woman should opt for a double mastectomy if she had a strong predilection towards breast cancer).

However, in early December 2013, the FDA’s “strongly worded” warning letter to 23andMe went public. According to the letter, the genetic company had simply avoided the red tape of the FDA and had been selling and marketing the company with no sign-off from the government. 23andMe, located in the tech mecca of Mountain View, Calif., was founded by the wife of Google’s founder Sergey Brin, Anne Wijcicki, and blended technology with the medical field. The FDA was furious.

An uphill battle

“Even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the (device) for its intended uses, which have expanded from the uses that the firm identified in its submission,” writes the FDA.

The technology behind saliva test kits is ever-evolving. Saliva is simple to collect, painless, and can be done just about anywhere. According to the National Institute for Health (NIH), the agency fully supports saliva technologies to point to possible health conditions, and the development of portable, rapid and small processing technologies means people can get diagnoses and treatment faster–assuming the device is approved and safe.

The technology behind devices which allow for fast, affordable disease detection and health monitoring are a booming industry. Soon, mini lab on chip technology will be readily available so that tests for diagnoses will be fast, portable and automated as a standard–blood samples could be totally eliminated as well as mouth tissue biopsies in the majority of cases. Everything from cancer to periodontal disease may be diagnosed with DNA/saliva testing in the near future. The “past” of DNA testing involved going to a doctor, getting a blood/tissue sample, sending the samples to a lab and waiting a few days.

The future of saliva testing

Now, “salivary diagnostic tests” are regularly used to test for HIV as well as alcohol and hormone levels. The NIH backed two studies in 2010 related to the advancement of saliva tech: “Salivary proteomic and genomic biomarkers for primary Sjogren’s Syndrome” and “Salivary biomarkers for early oral cancer detection.” Researchers have found the proteins and genes which can be expressed in salivary glands, and they are now defining the patterns and conditions when these genes are functioning within the whole biological system.

In the future, more salivary test results will be available immediately, and the device will be the size of a smartphone. Emergency medical techs can provide fast and extensive panels, and scientists are even considering the possibility of attaching minute devices to a person’s tooth to allow for ongoing monitoring. However, 23andMe stepped over the line because the FDA is very wary of marketers crossing over into “snake oil sales tactics” (which the US has a rich history of), even though this genetic testing company doesn’t raise any red flags.

When marketing meets medical, this is a fragile relationship–even in a time when DNA testing is at the heart of major lawsuits, medical breakthroughs and catching issues right in time.

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