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Genetic tests hit store shelves in the US

17 May 2010
Appeared in BioNews 558

UPDATE: Walgreens have postponed their decision to carry the Pathway Genomics genetic testing kits after the US Food and Drug Administration (FDA) began investigating the company. The FDA have asked Pathway for more information about how their product complies with FDA regulations. See References below for the latest news.

Personal genetic testing kits are to be sold in US pharmacies for the first time, US biotech firm Pathway Genomics has announced.

The testing kits will screen for genetic markers of more than 70 diseases including Alzheimer's, heart disease, breast cancer and obesity. Pathway Genomics - makers of the testing kit - also claim it can be used to test a persons's drug response to, for example, anti-cholesterol medication, and allow couples to investigate the possible risk of passing on hereditary diseases.

Users of the genetic test will send a saliva sample to Pathway Genomics Laboratories and later receive their results via an online report costing $79-$179 (£50-£120). Pathway recommends people discuss their results with either Pathway's in-house genetic counsellor or with their own doctor.

The kit - yet to receive the U.S regulator's approval - has raised concerns amongst scientists, bio-ethicists and genetic counsellors due to a potential for misuse or misunderstanding of results.

Professor Darrel Waggoner from the University of Chicago Medical School said: 'They are saying they can test for diabetes, hypertension and heart attack. That sounds very attractive to the uneducated consumer'.

However, Pathway's Vice-President of product management Ed MacBean said: 'The tests 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'.

The Food and Drug Administration (FDA) told the Chicago Tribune they are investigating medical claims made by Pathway Genomics in marketing the kits. However Pathway officials stress the test meets federal regulations and does not require FDA approval.

Kits, which are already available online, are set to retail in over 6,000 Walgreen pharmacies by mid-May at $20-$30 (£13-£20).

SOURCES & REFERENCES
Genetic testing kits to be sold at drugstores
LA Times |  12 May 2010
Genetic test kits to hit stores amid controversy
Chicago Tribune |  11 May 2010
Off-the-shelf genetics tests to hit US pharmacies
AFP |  11 May 2010
U.S. pharmacy chain delays plan to sell DNA test kit
Ottawa Citzen |  14 May 2010
Walgreen's Cancels Pathway Genomics DNA Test Kit Distribution
Gerson Lehrman Group |  13 May 2010
Walgreens postpones carrying Pathway Genomics genetic test kit
LA Times |  13 May 2010
Walgreens Postpones Plans to Sell Do-It-Yourself Genetic Test
Bloomberg Businessweek |  13 May 2010
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