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Harmful Procedures on Young Women Caused by Outdated HPV test, not by Pap Test
Date:12/3/2009

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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Read the full story at http://www.prweb.com/releases/hifidna/01/prweb3286014.htm.


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Source: PRWeb
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