Harmful procedures on young women caused by outdated HPV test, not by Pap test – HiFi DNA Tech sues FDA on December 11 for blocking new technology.
Trumbull, CN (PRWEB) December 2, 2009 -- Now the American College of Obstetricians and Gynecologists has confirmed that the invasive cancer workup procedure, also known as colposcopic biopsy, is harmful and may be unnecessary to some women who have received the procedure. However, its new guidelines incorrectly blame Pap test screening, which has been used for more than 50 years and contributed greatly to reducing cervical cancer rates in this country to the lowest in the world. In fact, according to a Harvard School of Public Health report, most of the unnecessary cervical biopsies regardless of patient age are caused by an out-dated FDA-approved human papillomavirus (HPV) test when its result is used with Pap test as a deciding factor for referring women to cancer workup. More than 95% of these cervical biopsies have been found to be excessive, wasting at least 10 billion dollars per year in unnecessary healthcare expenditure and causing injury which may lead to premature birth and increased risk of needing a Caesarean section when a woman becomes pregnant later, stated Sin Hang Lee, MD, a cancer pathologist and the president of HiFi DNA Tech.
HPV has more than 100 different types, of which about 13 are known to be capable of causing cervical cancer in some patients if its infection is not cleared by the patient’s own immune system, and becomes persistent. Since HPV cannot be seen or cultured, its detection is based on DNA testing. More than 20 years ago, the FDA approved an HPV DNA test to be used for detection of a group of high-risk HPV types. But this old test cannot distinguish the individual HPV types for evaluating persistent infection or distinguish a high-risk from a low-risk HPV type on every case. Unfortunately, this old HPV test has been marketed as a cancer test with FDA endorsement, causing many unnecessary cervical biopsies of young women, said Dr. Lee.
For some years, the FDA has erroneously regulated one single HPV test kit as a cancer test device, setting an unreasonable requirement for other innovative companies to meet when they want to introduce their newly developed and more precise DNA-based technologies for HPV testing. HiFi DNA has filed a lawsuit against the FDA to correct this misclassification (Case No. 09-1832-cv). All people concerned about women health care issues and reduction of unnecessary health care cost are invited to read the arguments between HiFi DNA and the FDA slated for the U.S. Court of Appeals for the Second Circuit on December 11, 2009.
HiFi DNA Tech specializes in facilitating transfer of the Sanger DNA sequencing technology to clinical laboratories to improve the accuracy of diagnostic DNA tests.
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