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  • Cystic Fibrosis is a hereditary disease caused by a gene mutation, and the test is designed to detect and identify gene mutations and variants.The application submitted by Third Wave, which is known as a 510(k) application, is a way to help companies get their products on the U.S. market faster.According to Third Wave, the Cystic Fibrosis molecular test fared well in performance tests conducted in
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