The FDA last week approved a DNA-based HPV test manufactured by Roche Molecular Systems as a primary screening option for cervical cancer. Called the "cobas HPV test," the method detects DNA from high-risk HPV subtypes, and is already recommended for use alongside the traditional pap smear.
But the FDA's new approval changes two distinct features of how the test is used and promoted: it permits the use of an algorithm that enables the HPV test to be used on its own, and allows Roche to market its HPV test directly to consumers. Combined, those factors could spell the end of the pap smear as we know it — a move that opponents say adds unnecessary confusion to an already complicated screening process, and jeopardizes women's health.
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