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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).

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
23 June 2014 - by Alice Plein 
Pathway Genomics, a biotech company based in San Diego, announced it will 'vigorously defend itself' against a patent infringement suit filed by Myriad Genetics and others...
26 July 2010 - by Chris Chatterton 
Direct-to-consumer genetic tests were called into question by the US authorities last week. An undercover investigation by the US Government Accountability Office (GAO) found that test results were often inaccurate and misleading....
12 July 2010 - by Nishat Hyder 
Proposals to genetically test incoming freshman and transfer students to the University of California, Berkeley (UCB), are under fire. UCB intended to offer a genetic test to its thousands of entrants, which would test three variants: genes that affect the ability to absorb folic acid, metabolise alcohol and digest lactose....
28 June 2010 - by Seil Collins 
The Food and Drug Administration (FDA) has told five US companies that the genetic tests they sell directly to consumers are unapproved....
5 June 2010 - by Dr Megan Allyse 
The University of California at Berkeley has recently received a great deal of attention for its revised curriculum for incoming first years which will offer students the opportunity to have a DNA sample analyzed for genetic variants...
4 May 2010 - by Dr Sophie Pryor 
Whole genome analysis has been used for the first time to gather clinically-useful information about the risk of developing diseases later in life. Stephen Quake, an apparently healthy, middle-aged professor of bioengineering at Stanford University in California, volunteered to have his entire genetic code screened. He was found to be at increased risk of developing diabetes, some cancers and of having a heart attack...
29 March 2010 - by Kyrillos Georgiadis 
The US National Institute of Health (NIH) has announced it plans to create a public Genetic Testing Registry (GTR). The database aims to improve the levels of information accessible to consumers, researchers and healthcare providers, about the availability, validity and clinical usefulness of genetic tests...
22 March 2010 - by Dr Charlotte Maden 
New research into diagnostic genetic tests for autism spectrum disorders (ASDs) has revealed the effectiveness of a new test that is currently not used in the first line of diagnosis. The findings were published online last week in the journal Paediatrics....
1 March 2010 - by Rose Palmer 
A personalised blood test that could track how a tumour responds to treatment and whether cancer is recurring has been developed by researchers in the U.S...
22 February 2010 - by Maren Urner 
A fast, low cost DNA test that can reveal a person's chances of developing certain inherited diseases could soon be a reality, scientists in Scotland have said. The test involves testing a patient's saliva to identify disease-related variations in their genetic code and is faster and cheaper than conventional methods, according to the study published in the journal Angewandte Chemie....
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