Navigation Links
Harmful Procedures on Young Women Caused by Outdated HPV test, not by Pap Test

Harmful procedures on young women caused by outdated HPV test, not by Pap test – HiFi DNA Tech sues FDA on December 11 for blocking new technology.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.


Read the full story at

Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved

Related medicine news :

1. Common drug for stopping preterm labor may be harmful for babies
2. Contact lenses purchased over Internet may place individuals at risk for harmful eyecare practices
3. Hot liquids release potentially harmful chemicals in polycarbonate plastic bottles
4. Heating Plastic Bottles Releases Potentially Harmful Chemical
5. New study shows extent of harmful human influences on global ecosystems
6. Aggression on Job More Harmful Than Sexual Harassment
7. Rodent study finds artificial butter chemical harmful to lungs
8. Sexual harassment at school -- more harmful than bullying
9. Children More Vulnerable to Harmful Effects of Lead at Age 6 Than as Toddlers, Says New Study
10. Children more vulnerable to harmful effects of lead
11. Saline is Safe Alternative to Harmful Cough and Cold Products
Post Your Comments:
(Date:6/26/2016)... Lake Orion, Clarkston, Michigan (PRWEB) , ... June ... ... direction with respect to fertility once they have been diagnosed with endometriosis. These ... tolerable intercourse but they also require a comprehensive approach that can help for ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can now ... and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings ... The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the ...
(Date:6/25/2016)... California (PRWEB) , ... June 25, 2016 , ... "With ... fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... customizable and all within Final Cut Pro X . Simply select a ProHand ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, ... and his M.D from the David Geffen School of Medicine at UCLA. He trained ... Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and ... their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took ... the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Bracket , a leading clinical trial technology ... outcomes platform, Bracket eCOA (SM) 6.0, at the 52 ... 30, 2016 in Philadelphia , Pennsylvania.  A ... product of its kind to fully integrate with RTSM, will ... 6.0 is a flexible platform for electronic clinical outcomes assessments ...
(Date:6/23/2016)... BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a ... second affiliate in Latin America . ... ... ... ...
(Date:6/23/2016)... The vast majority of dialysis patients currently ... are usually 3 times a week, with treatment times ... time, equipment preparation and wait time.  This regimen can ... patients who are elderly and frail.  Many elderly dialysis ... centers for some duration of time. Residents ...
Breaking Medicine Technology: