Gene-Testing Companies May Need U.S. Regulators Review, FDA Letters Say

Interleukin Genetics Inc. and CyGene Laboratories Inc. are among 13 makers of genetic tests sold directly to consumers told by U.S. regulators that their products may be medical devices needing federal approval.

The U.S. Food and Drug Administration sent letters to the companies saying the tests “appear to meet the definition of a device.” Interleukin doesn’t believe its tests are devices and will provide information to regulators to support its position, the Waltham, Massachusetts-based company said today in a regulatory filing.

The FDA sent similar letters in May to makers of gene- testing kits such as Mountain View, California-based 23andMe Inc. and San Diego-based Pathway Genomics that offer their services to the public. Agency officials have said they intend to regulate the area more closely and require test-makers to prove their products are effective and provide useful information.

Interleukin sells tests through the company’s website to help consumers learn about their heart health and choose diets that best fit them based on their individual genes.

CyGene offers “personal DNA testing that makes a difference” to help consumers learn if they have genetic predispositions to visions disorders including glaucoma and macular degeneration and heart problems, diabetes and obesity, the Coral Springs, Florida-based company said on its website.

The FDA also sent a letter to a 14th company, Sequenom Inc., based in San Diego, which markets prenatal diagnostic tests through doctors to help pregnant women learn if their unborn children have genetic abnormalities that may lead to birth defects. The letter said the diagnostic test may meet the definition of a device subject to federal review.

The U.S. House of Representatives Energy and Commerce Committee is scheduled to conduct a hearing tomorrow on gene- testing services.

To contact the reporter on this story: Rob Waters in San Francisco at

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