January 28, 2008 10:00 AM Eastern Time 

HiFi DNA Tech Questions FDA in Lawsuit - 'Why HPV DNA PCR Is Acceptable For Gardasil® Approval, But Not Acceptable For Safe Vaccination?'

BRIDGEPORT, Conn.--(BUSINESS WIRE)--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 companies to introduce their new devices into the market to assist clinical laboratories to perform accurate HPV genotyping, which will help the doctors give better health care to women,” said Dr. Lee.

The suit was filed by HiFi's attorney Anthony J. Musto of Fairfield, Conn. on Jan. 11, 2008, and an amended complaint was filed Jan. 22, 2008.

HiFi had previously petitioned the FDA for “down classification” of HPV DNA test to a virology test to replace its current cancer test classification, a concept dating from the 1980s. HiFi introduces a DNA amplification (known as PCR or polymerase chain reaction) device for replication of target HPV DNA. The amplified DNA material facilitates accurate HPV genotyping by direct automated DNA sequencing, a technology perfected over the past 15 years and contributing greatly to the early completion of the national Human Genome Project.

HPV recently came to the attention of the public through advertisements for Gardasil®, a vaccine approved to protect against 4 specific types of HPV.  The suit notes that the manufacturer of Gardasil® used PCR-based HPV tests to prove the genotype-specific safety and effectiveness of Gardasil®.  HiFi requests that the court review the denial, pointing out the inconsistency between allowing PCR-based testing for the approval of Gardasil®, but denying a test for HPV based upon the same technology.

Accurate HPV genotyping is especially valuable when determining whether to vaccinate a sexually active woman.  Vaccinating a woman infected with vaccine-relevant types of HPV with Gardasil® may enhance the risk of developing precancerous cervical lesions by 44.6%, as detailed in the study supporting Gardasil® approval.  With that risk, the FDA's statement that "FDA has not to date approved any HPV genotyping test for diagnostic use" may leave many women wondering whether to risk vaccination with Gardasil®.

It is astonishing to read the FDA statement “Probe design is a critical process for HPV DNA testing because of the large number of closely related HPV genotypes. Complex probe cocktails may crossreact and/or compete with one another…” used as a scientific basis for the denial. The FDA either did not read the contents of the petition before writing its decision or failed to keep up with the scientific advances since 1988 when the Digene HC2 HPV test was approved for marketing because neither the HPV DNA nested PCR device submitted for its review, nor the recommended accurate HPV genotyping by direct automated DNA sequencing for validation uses any probes at all,” said Dr. Lee.

HiFi DNA Tech, LLC tries to market its LoTemp™ nested PCR reagents as a test kit for preparing amplified HPV DNA samples. The latter samples are suitable for direct automated DNA sequencing in high complexity testing hospital laboratories to improve patient care. This new technology is published in Infectious Agents and Cancer. Milford Medical Laboratory currently provides this accurate HPV genotyping along with no-false-positive Chlamydia and gonococcus tests by direct DNA sequencing on a single liquid-based Pap specimen to serve gynecologists and their patients.