HiFi DNA Tech files lawsuit against FDA

Published on October 15, 2007 at 4:36 PM · No Comments

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® 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® 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) .


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