FDA Exempts Most DTC Genetics Tests From 510k
​​[Posted on: Thursday, November 9, 2017]

In an announcement this week, FDA classified most predictive genetic tests to be 510k-exempt. This is a remarkable about-turn for the Agency who till recently viewed genetic tests to be high risk devices that need 510k or even PMA approval. Last year only FDA first announced and then suspended a decision to strictly regulate genetic tests by requiring them to be registered with FDA, and classified based on risk. Many genetic tests were marketed as Lab Developed Tests (LDTs) and FDA wanted to regulate LDTs. The decision to regulate was suspended following the Presidential election. Then in April this year, FDA created a new category of genetic tests called the General Health Risk (GHR) tests, namely tests that can provide a healthy individual with a list of diseases he/she may be susceptible to based on genetic sequence analysis. The first such test approved by FDA was the tests developed by the Silicon Valley company “23 & Me”. In its announcement in April, FDA declared that all subsequent similar tests developed by “23 & Me”, and other developers like it, would only need 510k. This week’s announcement takes the next step to further deregulate genetic tests. In the last year, FDA has slowly but surely taken a 180 degree turn on its opinion for regulation of genetic diagnostics tests. Seven years may seem like a life time for the genetic test industry. In 2010, FDA had practically brought the industry to a grinding halt by issuing a flurry of Warning Letters to multiple genetic diagnostic assay companies asking to stop selling their tests to consumers. Only two years ago, FDA sent Warning Letter to a genetic diagnostic company to similar tests. There several thousand genetic tests available to the US consumer, most of them not regulated by the FDA. Due to the onerous process for formal approval as an In Vitro Diagnostic (IVD) tests, most genetic test developers had used the LDT route to bypass FDA. FDA has always cautioned that genetic diagnostics carry the risk of over-predicting due to the lack of robust standards and early stage of the science behind genetic diagnostic. While the technology to sequence, read, and analyze vast volumes of genetic sequences has come a long way in the last decade, most genetic markers are still based on probability algorithms based on few validated markers. Each company has its own proprietary algorithm due to lack of standardization. Some concerns have been raised regarding the reliability of the conclusions derived from these tests. However, FDA seems to want out. It does not anymore believe that it should regulate these tests vigorously. It still wants the providers to follow good quality but being 510k exempt these tests will be available practically unsupervised by the FDA. It is a paradigm shift in the regulation of genetic tests. The risk of a GHR test being harmful to a consumer is so low that it is about time FDA lets these tests work their own credibility with consumers. By making them exempt, the providers will not be able to use the FDA stamp of approval as the 510k or PMA tests which could be a better to inform the consumer to use these at their own risk. Let the market work out itself.