HiFi DNA Tech Files Lawsuit Against FDA Over Inaction in Reclassification of Human Papillomavirus (HPV) Polymerase Chain Reaction (PCR) Test.

TRUMBULL, Conn. -- A lawsuit was filed Oct. 12 in U.S. District Court against the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) related to reclassification of HPV DNA tests from class III to class II devices. The inaction by both agencies hinders introduction of new and affordable HPV testing to improve women's health care.

The suit was filed by a manufacturer of DNA test reagents, HiFi DNA Tech through its president, Sin Hang Lee, MD, a Connecticut pathologist. The complaint for relief was filed in U.S. District Court for the District of Connecticut in Bridgeport, CT.

"The inaction of both federal agencies blocks availability to women of newly developed molecular diagnostic tests that determine if they have the most common sexually transmitted infection using the advanced PCR and DNA sequencing technology which eliminates the false positive and inaccurate genotyping results associated with other methods," said Dr. Lee. Persistent infection by an HPV of only certain genotypes may lead to cervical precancerous lesions and cancer.

For 20 years the FDA has regulated the single HPV test as a cervical cancer test, rather than a viral DNA test. HiFi DNA Tech, LLC has requested the FDA to down-classify HPV tests to class II virology testing devices to keep pace with the current understanding of the relationship between development of precancerous cervical lesions and persistent infection caused by HPV. "Specific HPV genotyping is now recognized to be important in following up patients with persistent HPV infections. 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," said Dr. Lee.

The need for a PCR-based detection followed by accurate genotyping of HPV has become more urgent in view of the recent introduction of Gardasil[R] vaccination to sexually active young women. As indicated in the Merck clinical trial data filed with the FDA, there may be the potential for Gardasil[R] to increase the risk of developing high-grade precancerous cervical lesions by 44.6% in subjects who have PCR-positive and seropositive evidence of persistent infection with vaccine-relevant HPV types prior to vaccination, said Dr. Lee. There are more than 40 HPV genotypes that can cause human infections. Young women with HPV infections should know the specific genotype that they carry to manage their own health. The current FDA-approved HPV test cannot provide specific HPV genotype information to their doctors.

On March 7, 2007 Trumbull-based HiFi DNA filed the HPV PCR test reclassification petition which is published on the FDA Dockets Management website under docket no. 2007P-0210 for public comments. Pursuant to the Federal Food, Drug and Cosmetic Act, the Secretary of HHS (Commissioner of FDA) shall by order deny or approve the petition not later than 210 days after the filing of such petition, said Dr. Lee.

HiFi DNA Tech has developed the nation's first PCR/DNA sequencing-based clinical HPV genotyping methodology which is published in www.infectagentscancer.com/content/2/1/11, and now used as a routine HPV test at Milford Medical Laboratory (see www.hpvtyping.com)