FDA Warns Three Companies Over DTC Genetic Tests

Posted 09 November 2015 By Michael Mezher


Last week, the US Food and Drug Administration (FDA) sent letters to three genetic testing companies for marketing unapproved direct-to-consumer (DTC) tests.

The letters are addressed to three companies: DNA4Life, DNA-CardioCheck, Inc. and Interleukin Genetics, Inc., which FDA says are marketing genetic tests to consumers without being cleared.

In each of the letters, James Woods, FDA Deputy Director for the Patient Safety and Product Quality Office of In Vitro Diagnostics, says the agency is "unable to identify any … clearance number" for the tests cited, and instructs the companies to either show that the tests have been cleared, or provide their rationale for why the tests do not need to be cleared.

FDA Press Officer Eric Pahon told Focus that "FDA appreciates that many consumers would like to be informed about their genomes, and their genetic risk for development of future disease. We agree that access to tests through a DTC model can allow consumers to take responsibility for certain aspects of their health, and to learn more about genetics and its contributions to risk, among other probable benefits. We believe that certain types of tests are being appropriately offered through the DTC model, but others may need to demonstrate that they are safe and effective and that appropriate controls are in place to mitigate risks."

FDA Letters to Genetic Testing Companies
CompanyTest NameIndication or Claim


Pharmacogenetic Report

"Intended to predict how patients will respond to more than 120 of the most commonly prescribed medications."

DNA-CardioCheck, Inc.


"Intended to test for DNA genetic markers linked to thrombophia, deep vein thrombosis, cardiovascular disease and stroke."

Interleukin Genetics, Inc.

PerioPredict Genetic Test, Osteoarthritis Genetic Test, Weight Management Genetic Test

"Intended to identify individuals with genetic predisposition for increased risk to diabetes and heart attack, osteoarthritis associated conditions, and obesity-related genotype for weight loss."

In September, FDA sent a similar letter to Pathway Genomics concerning the company's cancer detection diagnostic. In the letter to Pathway Genomics, Woods said the agency could not find "any published evidence that [Pathway's] test or any similar test has been clinically validated."

In FDA's letter to Interleukin Genetics, the agency references a 2010 letter in which FDA also called the company out for marketing its tests to consumers. According to FDA, Interleukin Genetics' 2010 response claimed their tests were laboratory developed tests (LDTs). However, FDA says upon review "it appears [Interleukin Genetics] is offering these tests under a Direct-to-Consumer model."

Currently, LDTs do not need to be cleared by FDA, though the agency says it will exercise its oversight of any diagnostics being marketed directly to consumers.

Last year, FDA also announced plans to increase its oversight of LDTs through a risk-based approach to enforcing premarket and postmarket requirements. In its draft guidance, Framework for Regulatory Oversight of Laboratory Developed Tests, the agency says that the increased complexity of LDTs and the risks posed by faulty tests necessitate greater oversight, including "pre-market review for higher-risk LDTs."

The prospect of FDA regulating LDTs through draft guidance has spurred Congress to try to create a pathway by which it would regulate LDTs as in vitro clinical tests.


On Friday, DNA4Life CEO Richard Zimmer told Reuters his company's test, which launched in October, do not require clearance by FDA.

However, because DNA4Life's test is intended to predict how patients will respond to many commonly prescribed drugs, two experts who spoke to Reuters expressed concern that pharmacogenetics tests would likely require FDA approval and expressed concern about how patients would use the information the tests provide.


When reached for comment a representative of Andrology Laboratory Services, Inc., which was affiliated with DNA-CardioCheck said the company no longer sells the DNA-CardioCheck test. When asked how recently the DNA-CardioCheck test was sold, the representative said: "I think it was about five years ago, or longer than that," and said the lab now primarily handles paternity tests, which it markets as DNA-ID Check.

However, both tests are still listed on the company's website.

The other companies involved did not respond to requests for comment.


Letter to DNA-CardioCheck, Inc.

Letter to Interleikin Genetics, Inc.

Letter to DNA4Life

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Categories: In vitro diagnostics, Medical Devices, Compliance, News, US, CDRH

Tags: Direct-to-consumer, DTC, Genetic tests, Laboratory Developed Tests, LDT, LDTs, DNA4Life, DNA-CardioCheck, Interleukin Genetics

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