Genetic Tests Offer Few Real Benefits, Federal Investigation Concludes

Genetic tests sold directly to consumers generate "misleading" results that are "of little or no practical use," according to a Government Accountability Office report released on Thursday, CQ HealthBeat reports (Reichard, CQ HealthBeat, 7/22).

Genetic testing has come under increased scrutiny after Walgreen initially agreed to sell a Pathway Genomics product but dropped the plan after FDA questioned whether the test could be sold legally without the agency's approval (California Healthline, 6/15).

Details of Inquiry

GAO's findings are based on an undercover investigation of four genetic companies: 23andMe, deCODE Genetics, Navigenics and Pathway Genomics (Steenhuysen, Reuters, 7/22).

For the report, five GAO investigators submitted saliva samples to the four companies. They requested tests that cost between $299 and $999 and were designed to predict an individual's genetic risk for conditions such as Alzheimer's disease and breast cancer (Corbett Dooren/Wilde Mathews, Wall Street Journal, 7/23).

The investigation found that the tests produced contradictory results for the same conditions 68% of the time. Four of the five investigators received results that were inconsistent with their family histories (Reuters, 7/22).

For example, one investigator was told he was at a "below average," "average" and "above average" risk for high blood pressure and prostate cancer, while another investigator who was diagnosed previously with atrial fibrillation was told he was at a below average risk for the condition (CQ HealthBeat, 7/22).

Testing Company Officials Defend Products

Representatives from the four genetic testing companies defended their products, noting that results could vary because the products emphasize different genetic markers (Wall Street Journal, 7/23).

Navigenics CEO Vance Vanier said that "personalized genetic testing offers important benefits in strengthening prevention and wellness, improving health literacy and reducing health care costs for the American public" (CQ HealthBeat, 7/22).

FDA To Develop Regulatory Framework

Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, noted that none of the genetic tests currently on the market were approved by the agency as "accurate, reliable and clinically meaningful."

Shuren added that FDA plans to set up a regulatory framework for lab-developed tests that will be phased in according to patient risk.

All the companies were asked to meet with FDA to discuss the regulatory status of their tests (Reuters, 7/22).