Healthcare Debate gets Federal Court Hearing Dec. 11; MD Claims FDA’s HPV Action Costs Extra $10b and Extra Worry for Women


HiFi DNA and FDA will argue in second court of appeals - conflicts between legal agenda and science-based guidance of the FDA on how to regulate HPV testing


Trumbull, Conn. – The FDA will be held accountable during oral arguments Dec. 11 in federal court for its “inappropriate classification of a virus DNA-replicating device as a cancer test.” The misclassification costs women extra worry and society at least $10 billion a year, according to HiFi DNA Tech, a Connecticut-based leader in DNA-based testing procedures.


HiFi DNA Tech has appealed to the U.S. Court of Appeals for the Second Circuit in Manhattan, asking the court to reverse the FDA’s refusal to down-classify a human papillomarvirus (HPV) DNA replication device from a class III cancer test category to a class II virology device category or, in the alternative, remand the case to the district court for further fact finding. 


The oral argument is set for 10 a.m. Dec. 11, 2009 at Daniel Patrick Moynihan U.S. Federal Courthouse, 500 Pearl St., NY, NY 10007. The hearing is open to the public, who may wish to witness what has been described by the Sin Hang Lee, MD, HiFi DNA’s president as “a historic event that may impact the health of many women.” See the following documents: Appellant Brief, Appellee Brief, and the Appellant Reply.


HiFi DNA Tech says while the FDA’s legal department insists on regulating HPV testing as a cancer test, as promulgated in all its court documents, its scientific arm has re-emphasized that the only FDA-approved “HC2 High-Risk HPV DNA Test is a laboratory test used to show the presence or absence of the genetic (DNA) material from the Human Papilloma Virus (HPV), in cells from a woman's cervix.”  


Dr. Lee said “this inappropriate classification by the FDA has allowed the vendors to market the HPV test as a cancer test ‘to determine the need for referral to colposcopy’, a procedural cancer workup.”  Over 95% of the cervical biopsies based on referrals by this HPV test as a means of triage in the U.S. are unnecessary and cost more than $10 billion a year, Dr. Lee cited the literature.

He added that “In this case, the FDA misapplied the medical device statute to classify a simple virus DNA-replicating device as a cancer test.” The FDA also arbitrarily and capriciously created its own definition of “probes” as encompassing “primers” in nucleic acid science in an attempt to justify its faulty reasoning for rejecting an HPV polymerase chain reaction (PCR) device, stated Anthony J. Musto, the attorney for HiFi DNA.

Dr. Lee said, “as a reason for its denial order, the FDA claimed HiFi’s probe design has not been sufficiently shown. In fact, the HiFi’s PCR device does not use any probes at all. Instead, it uses consensus PCR primers accepted by all scientists in the field to replicate HPV DNA for further sequencing analysis. In a document entitled “Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses” issued by the FDA on September 9, 2009, the scientific arm of the Agency has clearly acknowledged that PCR/DNA sequencing “is especially important for HPV genotyping assays to establish that the correct HPV genotype has been identified”.


HiFi DNA Tech specializes in facilitating transfer of the Sanger DNA sequencing technology to clinical laboratories to improve the accuracy of DNA tests in laboratory medicine.


Contact Ken Warren, 203 891-9001