HiFi DNA President challenges NCI endorsement of Inaccurate HPV tests for referring women to unnecessary and costly cervical biopsies

August 24, 2009 - TRUMBULL, Connecticut – A National Cancer Institute (NCI) investigator’s endorsement of inaccurate high-risk HPV test to refer women to cervical cancer tests, despite the weak evidence of its value, is “unfortunate and inappropriate.” Sin Hang Lee, MD, president of HiFi DNA Tech, in a letter published in Infectious Agents and Cancer entitled “HPV test is a virology test, not for predicting cancer,”challenged the official Commentary of Dr. Philip E. Castle, principle investigator of the NCI human papillomavirus (HPV) project.

Since his commentary was dispatched from an office of the NCI and published in a peer-reviewed international scientific journal, Dr. Castle’s opinion “will unfortunately influence many health care policy makers whose decisions will in turn affect the welfare of many women worldwide,” said Dr. Lee.

Dr. Lee said the NCI investigator publicly endorses using inaccurate high-risk HPV tests to refer women to cervical cancer workup, “despite the cross-reactivity to these weakly carcinogenic or non-carcinogenic HPV genotypes.” This, said Dr. Lee, is unfortunate and inappropriate.

Dr. Castle recommends “once-in-a-lifetime low-cost and rapid HPV testing” in low-resource countries while knowing that this “will need sufficient numbers of highly-trained colposcopists to handle the clinical volume of screen positives, which could approach 10-15% of the population in many locations.” In the USA, it has been proven that using one-occasion HPV testing to refer women to cervical cancer workup has generated 95% unnecessary cervical biopsies at great cost to society.

In China, this number may reach 10 million 4-quadrant cervical biopsies in a single province if the recommendation is implemented. The downstream cost of such a low-cost testing would be enormous. Dr. Lee wants to initiate public discussions on this recommendation, he said in his letter to the editor.

In the past, Dr. Castle stated on the record that “the medical community should emphasize persistence of cervical HPV infection, not single-time detection of HPV, in management strategies and health messages.” Unfortunately, Dr. Castle’s Commentary was not formulated on his past statement, said Dr. Lee.

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

Contact Ken Warren 203 891-9001