HiFi DNA Tech tells FDA to reduce unnecessary biopsies on women; rescind approval of expanded use of human papillomavirus (HPV) test results for sending patients to cancer workup

January, 5, 2009 - TRUMBULL, Conn. – The Trumbull, CT-based HiFi DNA Tech wants the US Food and Drug Administration (FDA) to reduce unnecessary biopsies on women, by rescinding its approval of expanded use of human papillomavirus (HPV) test results for triage referral to colposcopy.

 “More than 95% of referrals to colposcopic biopsy for diagnostic workup in the U.S. are performed needlessly on healthy women or women who have mostly reversible cervical cellular change. Screening with combined cytologic and HPV testing leads to the highest number of excessive colposcopic referrals,” quoted Sin Hang Lee, M.D. from a publication by the Department of Health Policy and Management, Harvard School of Public Health in his letter sent to the FDA Commissioner. Dr. Lee requests immediate FDA action to reverse this trend by withdrawing the approval order of March 31, 2003.

 Dr. Lee, a cancer pathologist and the president of HiFi DNA Tech, brought to the attention of the Commissioner that the FDA Microbiology Advisory Panel was charged to deliberate on a premarket approval supplement to an HPV test device for use “as an aid to determining the absence of high-grade cervical disease or cancer” at an open session meeting held March 8, 2002. Instead, against the concerns raised by FDA’s own scientists and panel members, the Office of the In Vitro Diagnostic Devices issued an FDA approval for expanded use of the HPV test to screen patients with ASCUS (atypical squamous cells of undetermined significance) Pap smear results to determine the need for referral to colposcopy,” a use that the manufacturer sponsor did not request the Panel to deliberate on and was in fact opposed to by the panel members at the open session meeting.

 “Based on this approval supplement language, the HPV test has been marketed as an aid to channel women into excessive colposocopic biopsies for a remote possibility of detecting precancer change or cancer. During the same period, the value of the device manufacturer jumped up more than 5 times to $1.6 billion when it was finally sold in 2007,” said Dr. Lee.  

 He added, “Transient HPV infection is very common among sexually active women, and only a persistent infection by certain genotypes of HPV, indicated by detection of the same genotype of HPV on repeat testing over a period of time, in association of atypical cellular changes on Pap smear poses a risk, if untreated, to progress to precancer changes or cancer in rare cases.”

 HiFi DNA Tech introduces a new low temperature PCR system to reduce the cost of preparing samples for HPV genotyping by DNA sequencing to monitor persistent HPV infection, the technology now used at Milford Medical Laboratory where Dr. Lee is the medical director.  

 HiFi DNA Tech filed at the District Court against the FDA for its denial to a petition for down-classifying the HPV test from a Class III cancer test to a Class II virology test to reduce the burden on small innovative manufacturers to introduce their new HPV test devices into clinical practice to improve patient care and to reduce the health care cost. The case is waiting for the judge to set a court date for the open hearing. 

 Contact: Ken Warren at 203-891-9001