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MILFORD, Conn.–(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.
“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.”
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.
According to Dr. Lee, there are at least 13 high-risk HPV genotypes, and
neither the NCI nor the vaccine manufacturers have data on which HPV
genotypes are most prevalent in the mainstream young American women who
are the target of HPV vaccination. The vaccines being marketed are
effective against only two high-risk HPV genotypes, which are most
prevalent in some foreign countries, such as Costa Rica.
S.A.N.E. Vax, Inc., Dr. Lee and Milford Medical Laboratory have
partnered to help American women be informed, be engaged and be safe.
