WASHINGTON: Some folks are salivating at the prospect while others are spitting fire. A trendy bio-tech company's move to sell through retail outlets a genetic test kit that can assess users' predisposition to various diseases has sparked off a furious debate in America over its ethical and moral dimensions.
Using the $20-$30 (around Rs 1,500) 'Spit Kit', customers can mail a dab of their sputum to labs for tests that will examine DNA variations to determine their risk of getting heart disease, diabetes, various forms of cancer, besides their reaction to common drugs.
The tests will separately cost up to $300, depending on the range and depth of information sought.
Pathway Genomics, a San Diego start-up, had announced on Tuesday that it would start selling the 'Spit Kit' later this week through the nation's 7,500 Walgreen stores. Packaged in a box with the more palatable "Discover Your DNA" imprint, with a stamped envelope enclosed, the spit kit can be mailed back to company. Customers can then go to the Pathways website to order specific tests and pay the required fees. They can also get the results via the Web.
The idea is not novel. Personal genomics companies, mostly Internet-based, have been around for around three years; and drug stores carry individual diagnostic kits for pregnancy, cholesterol, blood sugar, even paternity tests. But Pathway has pushed the envelope by going retail, hoping to trump front-runners such as Navigenics and 23andMe, which are still Internet-based.
The move is already attracting scrutiny from the US Food and Drug Administration (FDA), which says it has not approved or validated the test kit. Ethicists are also concerned. They say learning about predisposed diseases will raise moral issues relating to marriage, childbirth, inheritance, and even business and professional decisions.
"Genetic testing is a complex, difficult and emotionally laden medical process, which requires extensive counselling, contextualization and interpretation," Dr Michael A Grodin, professor of bioethics, human rights, family medicine and psychiatry at Boston University Schools of Medicine and Public Health, said on ABC News, even as arguments raged online.
Medical insurance companies and the clergy are yet to pitch in.
Genomics industry enthusiasts, including a Utah company that has sold over 100,000 paternity DNA tests since it was introduced in March 2008, say such personalized medicine is the wave of the future and people have the right to know, if they want to.
Pathway, on its part, says FDA clearance is not necessary to sell the Spit Kit, because, it insists, the tests are not intended for use in diagnosis, treatment or for the mitigation or cure of a disease. "It does provide information that allows a person to learn about their health to make healthier lifestyle choices," the company said.
No comments:
Post a Comment