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Retailing Genetic Testing Kit: FDA Steps In, Supermarket Steps Back
The US Food and Drug Administration has sent a letter to Pathway Genomics informing the firm that its genetic testing kit requires marketing clearance from the agency.
Pathway Genomics' tests purport to examine saliva samples to assess a person's risk of getting more than 70 diseases including heart disease, hypertension and lung cancer. The company also offers carrier testing for pre-pregnancy planning, which would test for mutations that cause genetic disorders such as cystic fibrosis and Tay-Sachs disease.
The $20 kits contain a plastic tube to contain saliva, instructions and a postage-paid envelope to send the spit sample to the laboratory. The testing costs about $79 to $249.
Despite such claims, geneticists say the scientific understanding is not sufficient to accurately assess risks for common diseases such as cancer, diabetes and heart disease. While data about genetic markers can be obtained, scientists don't know exactly what those mean.
"Many of these markers are not understood, even what genes they are affecting right now," said Dr. Kenneth Offit, chief of clinical genetics service at Memorial Sloan-Kettering Cancer Center in New York. "It's a very, very early stage in this level of genomic research."
FDA said that the firm's Genetic Health Report a home-use saliva collection kit that is at the center of a deal announced earlier this week with retail pharmacy chain Walgreen's "appears to meet the definition of a device as that term is defined" by federal legislation. The agency said that it has no record of the product being cleared for marketing.
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More News on: DNA Finger Printing, Genetics and Stem Cells, Genetic Testing of Diseases, Paternity Testing - Whose Baby Is It Anyway?
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