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HiFi DNA Sues FDA for Dragging Feet on Reclassifying HPV Dx

NEW YORK (GenomeWeb News) — HiFi DNA Tech said today that it filed a lawsuit against the US Food and Drug Administration last week for allegedly failing to respond in time to the company’s petition to reclassify DNA tests for human papillomavirus from class III to class II devices.   
 
The Trumbull, Conn.-based company, which makes reagents and has developed a PCR-based HPV genotyping methodology, said the agency is required to either approve or deny such petitions within 210 days under the Federal Food, Drug and Cosmetic Act. The company filed its petition to reclassify the test in May.
 
The agency's "inaction" blocks the availability of newly developed molecular diagnostic tests and may be hindering women from accessing treatment and slowing therapeutic decision-making, President Sin Hang Lee said in a statement.
 
“Reclassification of HPV tests as class II in vitro devices will encourage small innovative companies to use the less burdensome 510k applications to introduce their new technologies for more accurate HPV testing on a competitive basis," Lee added.
 
The FDA did not immediately return a telephone call seeking comment.