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HiFi DNA Wants FDA to Explain HPV Test Denial to a Judge

NEW YORK (GenomeWeb News) – HiFi DNA Tech has filed a second lawsuit against the US Food and Drug Administration to get the agency to explain before a court its reasons for denying the company’s petition that it reclassify its molecular diagnostic test for human papillomavirus, the company said Monday.
The firm has been petitioning the FDA to lower its classification of the HPV DNA nested PCR Test from a Class III to a Class II device, on the basis that this test is a PCR-based genetic test similar to one that was used in the creation of the FDA-approved drug Gardasil, which is manufactured by Merck.
That petitioning included a lawsuit filed in October in Connecticut that was aimed at getting the FDA to review the petition and rule one way or the other, because the company said the agency had passed its deadline on issuing a decision.
The company said at the time that reclassification as a Class II device would enable it to file using the “less burdensome” 510(k) application to attempt to take its DNA test to market.
According to an FDA rule written into the Federal Food, Drug and Cosmetic Act in the mid-1970s, “devices” are automatically classified as Class III until they are reviewed and graded otherwise. The FDA said in its denial letter to HiFi DNA that a Class III device is subject to premarket approval “to provide reasonable assurance of its safety and effectiveness.”
But company President Sin Hang Lee said the FDA bungled the review because it based its decision on its internal protocol and rules, and not on science.
“The FDA ought to come to court to answer these questions, because we think the denial is not based on science,” Lee told GenomeWeb Daily News on Monday. Lee added that the FDA did not adequately review the technology in question.
According to the FDA’s letter to HiFi DNA, the filing party must demonstrate that its device has “special controls … that would provide a reasonable assurance of the safety and effectiveness of your device.” These special controls are necessary if a device is to be used in “supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,” according to the FDA.
HiFi DNA said that its HPV test is not intended for use that is of “substantial importance in preventing impairment of human health,” but is intended only as “an adjunctive assay,” and is meant to be used in tandem with a Pap test. Therefore, it is being held to an illegitimate standard, said Lee.
Lee hopes the lawsuit will force the FDA to go before a judge to defend its scientific reasons for denying the device because he does not believe there is a scientific reason at all.
“The FDA just copied a ‘Deny’ order,” Lee said, and used it without reading the application and its contents.
The FDA did not immediately return a request for comment.

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