In-Home Genetic Testing: Good or Bad?

If you could purchase a test kit from your local drug store that would tell you whether or not you have genetic markers for serious and often life-threatening diseases such as prostate cancer, would you add it to your shopping cart?

California-based company, Pathway Genomics, the makers of a new and highly controversial in-home genetic test kit says that people should have the right to such a test – that knowing whether or not you have genetic markers for certain diseases will help people take better control of their lifestyle choices and overall health. The US Food and Drug Administration (FDA) and some medical experts aren't so sure.

The test kits would cost between $20 and $30. Each kit comes with a vial and shipping envelope. Consumers would send a DNA sample (saliva) to a lab and results would be sent to the consumer either online or by mail for an additional fee of $79 to $179. The test is said to assess the consumers’ risk of developing more than 70 diseases including prostate cancer and heart disease.

The FDA requested last week that Pathway Genomics provide further information to the agency about the test kits and also provide an FDA approval or clearance number for the product. The letter, signed by the FDA’s deputy director for patient and product quality, said: "If you do not believe that you are required to obtain FDA clearance or approval, please provide us for the basis for the determination."

Amid the FDA’s investigation into the tests, both Walgreens and CVS stores have decided to delay plans to sell the test, branded as Insight. Walgreen’s initial plan was to start selling Insight last week, and CVS planned to begin offering the product in stores this summer. Both companies are holding back until talks between Pathway Genomics and the FDA are resolved.

Some medical experts and the National Society of Genetic Counselors have expressed concern over how consumers would use results gathered from the test. There’s concern that the test would not be administered under the guidance of a trained medical professional, and so counseling and further information would not be readily available like they would if the testing were done under the supervision of a doctor.

It will be interesting to monitor the outcome of this situation in the coming weeks and months.

We want to know what you think. Should consumers have the right to independently get genetics testing without the counsel of trained medical professionals? Would you want to know if you have genetic markers for diseases? Why or why not? Do you think the results would cause worry or empower people with knowledge about their health? Please share your thought in the comments below.

Sources: Los Angeles Times & Chicago Breaking News