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HiFi DNA Tech Questions FDA in Lawsuit - 'Why HPV DNA PCR Is Acceptable for Gardasil(R) Approval, but Not Acceptable for Safe Vaccination?'

Published in Hospital Law Weekly, February 14th, 2008

HiFi DNA Tech has filed suit against the U.S. Food and Drug Administration here in U.S. Federal District Court requesting the high court overturn the FDA's denial of HiFi's petition for reclassification of its human papillomavirus (HPV) DNA detection device from the more-restrictive class III to class II.

"The FDA should be encouraging innovative companies to introduce their science-based devices to facilitate transfer of the molecular technologies developed in the past 15 years to clinical laboratories to improve patient care," said Sin Hang Lee, MD, of HiFi DNA Tech, based in Trumbull, Conn.

"Changing the classification encourages innovative...

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