HiFi DNA Tech
Recently Approved HPV Test May Prompt Unnecessary Surgical Biopsies on Women: HiFi DNA Seeks Transparency of “Results” from the FDA and Scientific Data on Newly Approved Human Papillomavirus HPV Tests
Published in Medical Device Business Week, April 15th, 2009
Trumbull-based HiFi DNA Tech issued a call to the US Food and Drug Administration (FDA) that its recent approval of an HPV test may improperly influence American physicians to order more unnecessary colposcopic biopsy cancer tests. HiFi DNA wants the FDA to publish the positive predictive value (PPV) and scientific basis for approving the Cervista HPV HR test to determine the need for referral to colposcopy and the Cervista 16/18 genotyping test.
“In this era of transparency, the scientific data should be made public to ensure that decisions made by the FDA do not lead to unnecessary surgical procedures, and also lead to increased national healthcare costs,” said Sin...
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