House Panel Probes Gene Tests

The Wall Street Journal

 

A House panel is investigating personal genetic test kits currently sold over the Internet after one company proposed selling its kits through stores operated by Walgreen Co. and CVS Caremark Corp.

Last week, Pathway Genomics, a closely held firm based in San Diego, announced plans to sell its Insight Saliva Collection Kit through 6,000 Walgreens stores for between $20 to $30 a test. Saliva collected from the test would be sent to the company and analyzed for an additional price of $79 to $249.

The test, which Pathway currently sells through its website, is designed to predict a person's risk for developing certain diseases or how they might respond to certain drugs. It can also predict the risk of 37 genetic diseases caused by recessive genes that might be passed to a child from parents.

But after the Food and Drug Administration raised concerns about the test, Walgreen and CVS Caremark both said they would hold off on selling the kits until all the regulatory issues are worked out with the agency.

The test isn't FDA-approved, but Pathway Genomics has said it didn't think the test needed agency approval. The company said it's currently working with the FDA to make sure it is compliant with agency rules.

Now, the House Energy and Commerce Committee is seeking information about Pathway's test along with tests from 23andMe Inc. and Navigenics, two other closely held firms based in California.

All three companies sell tests on the Internet that analyze a person's salvia to determine their risk of certain health conditions. The tests also allow people to obtain genetic ancestry data.

Rep. Henry Waxman, D-Calif., the chairman of the Energy and Commerce Committee, along with other lawmakers on the House panel, sent letters to the three companies Wednesday requesting information about how they analyze the test and how accurate the test results are. The panel is also seeking information about how the firms collect, process and store individual genetic samples collected from consumers.

It wasn't immediately clear if the panel planned to hold a hearing on the genetic tests.

Walgreens to Begin Selling Genetic Testing Kits

The Chicago Tribune

Scientists, bio-ethicists and genetic counselors worry consumers will misuse or misunderstand test results

 

 

Coming soon to a drugstore near you, alongside the aspirin and greeting cards, will be the promise of answers to some of life's most personal mysteries: Am I at risk for Alzheimer's disease? Or breast cancer? Or obesity?

Starting Friday, Walgreens will begin selling Insight personal genetic testing kits, becoming the first major retail chain in the U.S. to offer home tests that say they assess the risk of developing one of dozens of different health conditions. CVS plans to have it in stores by August.

The product's introduction raises immediate concerns among scientists, bio-ethicists and genetic counselors. They worry that consumers will misuse or misunderstand the results of a test so open to interpretation it is potentially meaningless, or frightening, especially without a full medical assessment.

On Tuesday, the Food and Drug Administration told the Tribune it is investigating the medical claims the product's manufacturer, California-based Pathway Genomics, is making in marketing its genetic test, which hasn't been approved by U.S. regulators.

Pathway officials say the company's home genetic test meets federal regulations and doesn't require FDA approval.

"The tests conducted are not an in-vitro medical device and are not intended for use in diagnosis, treatment, mitigation or cure of disease. It does provide information that allows a person to learn about their health to make healthier lifestyle choices," said Ed MacBean, Pathway's vice president of product management. "If the FDA contacts us, we will discuss it and address any concerns they might have."

Drugstores already carry DNA paternity and gender prediction tests that can be done at home, and genetic test kits are sold online by several firms. But genetic testing typically requires a visit to the doctor's office, allowing for consultation with a health care professional.

Marketers think such kits could become as common as early pregnancy tests, helping consumers get initial information before going to the doctor.

"We recognize that for some people, genetic responses are becoming a more important component of managing their health care," said Jim Cohn, a spokesman for Deerfield-based Walgreens. "There are people who want to know more about their genetic makeup, and we pride ourselves on being convenient and accessible."

The Insight genetic test kit, priced at $20 to $30, comes with a vial and a shipping envelope. Buyers send a sample of their saliva to a Pathway Genomics laboratory and receive their results online. The report costs $79 to $179, depending on the type of test requested.

The kits will be appear on the shelves at about 6,000 of Walgreens' 7,500 stores nationwide.

Pathway Genomics Chief Executive Jim Plante said in a statement that his company is "revolutionizing" the way people access information about their genetics. "The value of knowing how genes play a role in our personal lives, and potentially the lives of our children, is critical for making well-informed health and wellness decisions," he said.

Pathway screens for genetic markers of more than 70 diseases, including diabetes, prostate cancer and cystic fibrosis. The company notes that "some markers have been researched more thoroughly than others, but scientific knowledge advances rapidly."

It recommends buyers discuss results with a doctor or one of Pathway's genetic counselors, particularly for complex health issues such as heart disease and cancer that have multiple causes, including lifestyle and environmental factors, MacBean said.

Scientists question the value of home genetic testing. For most diseases, no one knows exactly why one person gets it and another does not, said Peter Kraft, deputy director of the Program in Molecular and Genetic Epidemiology at Harvard School of Public Health.

"The company states, everyone has the right to know the secrets hidden within their DNA," he said. "Fair enough, but that is a lot of work. I don't think this is the way to go."

According to a paper published in The Lancet in May, a team of more than 30 researchers took a year to analyze the results from full-genome testing of a 40-year-old man with a family history of coronary artery disease who died suddenly. Although the amount of data they analyzed was far greater than that of Pathway's kit, the researchers used much of the same data on genetic health risks, disease risk and drug information.

Even then, the researchers acknowledged that the genetic information was incomplete, said Dr. Nilesh Samani, a professor of cardiology at the University of Leicester in England who wrote a commentary on the study.

Many of the risks have been calculated for the entire population, Samani said, but that doesn't mean it applies neatly to any one individual because of family history, lifestyle habits or, importantly, genetic variations.

Samani likened it to a card game in which you can only see a few cards. At first blush, you may be holding a bad hand, but what if the cards you can't see are all aces?

"You need to know the rest to know whether it is worthwhile," Samani said. "That is a limitation. It is a big limitation. [The companies] don't present it like this."