SANE Vax, Inc.
By: Norma Erickson
12 September 2010
The National Cancer Institute (NCI) announced on August 2, 2010 that it has awarded a $13.5 million contract to a Dutch diagnostic laboratory to perform reliable human papillomavirus (HPV) genotyping using a polymerase chain reaction (PCR) system with short target sequences for the cervical biopsy samples collected at the NCI.
Such reliable HPV genotyping technology was not used by the drug manufacturers in validating the efficacy of the genotype-specific HPV vaccines during the clinical trials required for Food and Drug Administration (FDA) approval, and has been rejected by the FDA for commercial distribution to clinical laboratories in the U.S. for general patient care.
This NCI contract confirms that the current FDA-approved HPV test kits for patient care in the U.S. are not reliable.
According to the pre-solicitation notice, HPV infections are very common in sexually active women and only a small subset progress to cervical cancer. When precancerous lesions appear, they may contain multiple types of HPV. It is difficult with the currently available FDA-approved HPV tests to determine whether the HPV strains present are responsible for causing the lesions, or simply there as a passenger.