MILFORD, Conn., Sep 20, 2010 (BUSINESS WIRE) — S.A.N.E. Vax, Inc. and Dr. Sin Hang Lee, on behalf of Milford Medical Laboratory, have agreed to offer a reliable human papillomavirus (HPV) genotyping test using a PCR system with short target DNA sequencing for safe vaccination practice.
Recognizing the alleged flaw in the two FDA-approved HPV tests, the National Cancer Institute (NCI) has awarded a contract to a Dutch diagnostic laboratory to perform “reliable genotyping using a PCR system with short target sequences” for the HPV isolated from biopsy samples collected in the NCI.
S.A.N.E. Vax, Inc. is a non-profit organization founded to promote safe, affordable, necessary and effective vaccines and vaccination practices. Dr. Lee said, “Milford Medical Laboratory will perform nested PCR with short target DNA sequencing for HPV genotyping on liquid-based cytology samples referred by S.A.N.E. Vax, Inc. at $50 per sample. Most health insurance companies will reimburse this cost.”
Norma Erickson, president of S.A.N.E. Vax, Inc., said she is disappointed that the NCI has become a business partner of the vaccine manufacturers and is promoting an unproven virology-based clinical oncology practice, using prophylactic HPV vaccination of adolescents, HPV testing, and colposcopic biopsies to replace the proven effective Pap smear screening for cervical cancer prevention. Worse, Erickson said, they do not appear to have a reliable HPV genotyping test for good patient care and monitoring the vaccination program prescribed for the American women consumers.
Based on the clinical trial documents submitted to the FDA, the primary endpoint used in the evaluation of the currently marketed HPV vaccines was mostly cervical intraepithelial lesions 2/3 (CIN2/3), representing a spectrum of poorly defined, poorly reproducible, often self-reversing precancerous histological changes, not a truly malignant pathology, said Dr. Lee.