FDA cites 5 companies for marketing unapproved personal genetic tests

FDA takes issue with genetic tests from 5 firms

WASHINGTON — The Food and Drug Administration has put five genetic test makers on notice that they must get federal approval before marketing their products for use by consumers.

The regulatory letters posted online Friday are the first sign that the government agency plans to crack down on companies marketing products that claim to predict inheritable diseases using DNA samples.

The FDA letters notify each company that their products are considered medical devices and therefore must be federally approved as safe and effective.

The letters posted online deal with specific technologies from: 23andMe Inc., deCODE Genetics, Illumina, Navigenics and Knome Inc.

23andMe Inc., deCODE Genetics and Illumina market tests that screen patients for their likelihood of developing health conditions or their response to various drugs. None of the companies have submitted their tests for approval, according to the FDA.

Navigenics and Knome Inc. make high-grade testing and software equipment that genetic companies use to analyze DNA samples. Under FDA regulations, those technologies must also undergo review as medical devices.

FDA asks each of the companies to contact the agency to make arrangements for submitting their products for review.

Companies like Mountain View, Calif.-based 23andMe have sold saliva-based test kits online for years with minimal oversight.

23andMe said in a statement it will respond to the agency’s letter, but disagreed that its tests require federal approval.

“We are sensitive to the FDA’s concerns, but we believe that people have a right to know as much about their genes and their bodies as they choose,” the company said.

The FDA began taking a closer look at DNA tests last month when rival company Pathway Genomics announced it would begin selling its products through Walgreen, the largest drugstore chain in the country.

Pathway’s test would have been the first low-cost, mass-marketed version of kits that screen for genes associated with diseases like prostate cancer, cystic fibrosis and diabetes.

A saliva collection kit plus full genetic analysis from Pathway was slated to cost about $275. Similar offerings from 23andMe and Navigenics have sold for between $400 and $1,000.

San Diego-based Pathway ultimately backed down from that plan after the FDA sent the company a letter indicating that it never submitted its products for federal review, a requirement for medical devices. The new letters posted by the FDA contain similar language.

The proliferation of consumer-marketed genetic tests has troubled many public health officials and doctors who worry that the products are built on flimsy data.

The biology of how DNA variations actually lead to certain diseases is still poorly understood, although a number of public and private institutions have been racing to find answers.