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The Food and Drug Administration (FDA) today approved the first DNA-based laboratory tests for an inherited disorder. The new tests, for blood clotting abnormalities, represent a significant advance in technology. FDA has cleared other genetic tests in the past, but none was DNA-based.
The new tests will enable clinical laboratories to identify people who have an increased risk of developing blood clots in the veins of their legs and elsewhere because of hereditary abnormalities in two proteins involved in blood clotting. Five to ten percent of all Americans have at least one of these genetic abnormalities. If untreated, blood clots can cause death.
“FDA’s oversight of DNA testing will help protect the public health in this newly-emerging and critical field,” said Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. “With FDA-approved DNA tests, consumers can have increased confidence that the tests work as expected and the results are reliable.”
The test kits, the Factor V Leiden kit and the Factor II (prothrombin) G20210A kit, manufactured by Roche Diagnostics Corporation of Indianapolis, Ind., are intended to be performed with other laboratory tests and procedures in people suspected of having blood clotting abnormalities.
To perform the test, DNA sequences from a person’s blood are amplified using Polymerase Chain Reaction (PCR), a method that produces millions of identical copies of the gene portion of interest. A fluorescent tag then binds to the amplified DNA and is used to measure the presence or absence of the clotting mutation.
The tests can be used to identify the Factor V Leiden or the Factor II genetic abnormality in persons who have a history of abnormal blood clots or whose relatives have such a history. Several professional organizations have issued guidelines for performing this type of testing.
FDA approved the tests for marketing based on clinical studies showing that DNA-based tests can identify mutations in people who have had blood clotting problems. The manufacturer also supplied data showing that the test detects these abnormalities with a high degree of certainty. The Roche tests performed nearly perfectly for identifying people who did or did not have the mutations known as Factor V Leiden or Factor II (prothrombin) G20210A.
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