Home genetic tests earn ‘F’

Published 10:03 pm Thursday, May 13, 2010

Plans by Walgreens to sell home genetic-testing kits were delayed this week when the FDA said it was investigating the tests.

No matter. When one needs “comprehensive genotyping testing” stat, it can be ordered from Pathway Genomic, or similar companies, online, where all the reliable medical stuff is found.

The “comprehensive” nature of the tests is one of the many problems. If someone wants to fork over money to be told they have a genetic propensity for obesity, so be it. But it is irresponsible, or worse, to include conditions or diseases that may have a genetic component, but whose cause is unknown. When these companies test for “lupus,” or “breast cancer,” or anything, all they offer someone is lots of room for misinterpretation and fear.

Misinterpretation can also cause people to underestimate their risk for more common diseases. About 5.3 million Americans have Alzheimer’s, and millions more are expected to develop it as baby boomers age — but less than less than 10 percent of people inherit the disease.

Online and over-the-counter is not the proper arena for serious medical testing. This isn’t “personalized medicine.” On the other hand, sending your genetic information off to these companies should raise a few privacy concerns.

The online genetic testers also offer testing for breast cancer. This is interesting, since until recently, one company held the only patents related to the genes BRCA1 and BRCA2, whose mutations have been associated with breast and ovarian cancers.

When the companies “test for breast cancer,” they mean they will give you “odds” for developing breast cancer, which one can read for free anywhere.

In a ground-breaking ruling in March, a federal judge struck down the patents held by Myriad Genetics on the BRCA genes. The case came about when a 42-year-old woman with an aggressive form of breast cancer wanted to be tested for the mutations. But it took a year and a half to get the test because Myriad Genetics did not contract with her insurance provider.

Judge Robert W. Sweet ruled that the patents were “improperly granted” because they involved a “law of nature.”

Invalidating gene patents will allow other companies to offer the tests, expanding availability and competitiveness, which is needed. Unlike the blanket over-the-counter testing.

As the online genetic testing company 23andMe advises: “If you have a strong family history of breast cancer you should consider talking to your doctor, who may suggest getting a clinical genetic test.”

This is good advice for all health concerns, genetic or otherwise.

Spitting into a vial and mailing it in won’t help anyone but the genetic entrepreneurs.