To confirm the validity of products, the Food and Drug Administration has ordered five Companies that proffer genome-sequencing tests to customers to offer scientific services for them. The tests that scan a person's DNA for gene variants linked with unambiguous diseases are medical devices entailing the agency's consent.
The California Company Navigenics proposes an analysis that offers information about how well the anticoagulant drugs warfarin and clopidogrel may function.
The FDA wrote to the Companies, saying “consumers may take medical decisions while relying on this information”.
The agency’s letters do not, however, ask the Companies to impede selling the tests but simply means that some of the services may not be legally marketed.
The FDA had asked if an additional over-the-counter DNA test, promoted by Pathway Genomics, could be vended lawfully without the agency's consent. This, in turn, had provoked Walgreens, the nation's principal drugstore chain, to plunge its idea to sell the test, which guaranteed to review a person's threat for breast cancer, heart attacks and a host of other ailments.
Alberto Gutierrez, an FDA official, further asserted that the Companies selling analytical tests had to put forth at scientific confirmation that a test consequence, either positive or negative, is associated to a disease or the risk of one.
The usefulness of information to doctors or patients need not be shown.
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