Genetic Test Kits To Hit Stores Amid Controversy

Genetic Test Kits To Hit Stores Amid ControversySoon, when you next visit a nearby drugstore, side by side with the aspirin and greeting cards, you will also be able to pick up a genetic test to unravel one of life’s mysteries, such as, whether you are at risk for Alzheimer, breast cancer or obesity?

Walgreens is all set to begin selling Insight personal genetic testing kits Friday, the first major retail chain in the US to offer home tests for assessing one’s risk of developing any one of a dozen different health conditions, with CVS stores marketing them by August.

Raising immediate concerns among scientists, bio-ethicists and genetic counsellors, the news has them worried that in the absence of a full medical assessment, consumers will misuse or misunderstand test results open to interpretation.

The US Food and Drug Administration (FDA) is investigating the medical claims the product’s manufacturer i. e. California-based Pathway Genomics, is making in marketing its test, not approved by U. S. regulators, yet.

However, Pathway officials say its home genetic test meets all federal regulations, without requiring FDA approval.

Ed MacBean, Pathway’s Vice President of Product Management said the tests are not an in-vitro medical device, nor are they intended for use in diagnosis, treatment, mitigation or cure of disease. The tests simply provide information for allowing a person to learn about their health, so they can make healthier lifestyle choices.

Already, drugstores are carrying DNA paternity and gender prediction tests for doing at home, while several firms are selling genetic test kits online. However, typically, genetic testing requires a visit to the doctor’s office for consultation with a health care professional.

It is believed these tests could become as common as early pregnancy tests, helping consumers get initial information before visiting the doctor.

The Insight genetic test kit priced at $20 to $30 comes with a vial and a shipping envelope. Buyers sending a sample of their saliva to a Pathway Genomics laboratory will receive their results online. Depending on the type of test requested the report will cost $79 to $179. The kits will not only be used to determine pre-disposition for chronic diseases like Alzheimer’s, cystic fibrosis, and Tay-Sachs disease, but also the response to common drugs like Plavix, Tamoxifen and Coumadin.

The kits will be sold at around 6,000 of Walgreens’ 7,500 stores nationwide.

However, as many of the risks have been calculated for the entire population, it does not mean it will apply to any one individual, because of family history, lifestyle habits or, importantly, genetic variations.

The tests will be available at Walgreen stores starting in mid-May.

According to the company, the testing kits will cost $20 to $30 each, including a saliva collection kit and a postage-paid envelope for customers to send their saliva sample to the Pathway laboratory.

Customers can also go to Pathway’s web site for ordering tests for drug response, pre-pregnancy planning and health conditions starting at $79 and going up to $249 for all three.

Navigenics Inc. and 23andMe Inc. are other companies offering direct-to-consumer genetic testing.