Cancer Genetics granted patent for genomic probe set used in test for cervical and other HPV-associated cancers

Cancer Genetics, Inc., provider of DNA-based cancer diagnostics, has received a formal Notice of Allowance from the United States Patent and Trademark Office for its genomic probe set used to detect biomarkers indicative of HPV-associated precancer and cancer of the cervix, anus, vulva, vagina, penis, oropharynx, and pharynx. US Patent 8,865,882 covers the four-probe set used in CGI’s proprietary FISH-based HPV-Associated Cancer Test (FHACT), which identifies genomic aberrations associated with progression to cancer. The FHACT test is currently available for clinical use in cervical cancer screening.

While traditional Pap smears and high-risk HPV testing have significantly reduced the number of cervical cancer deaths in the U.S., there remains a critical need for better, more precise genomic testing to identify those women truly at risk of cervical cancer. Pap smears have a high false-negative rate, and high-risk HPV testing cannot distinguish between higher-risk persistent infections and those that will clear on their own without medical intervention. As a result, under the current screening protocols, women who have abnormal Pap smear results and/or who test positive for high-risk HPV are routinely sent for further testing via colposcopy or cervical biopsy procedures, during which an additional cervical specimen may be collected for analysis.

Of the more than 55 million Pap smears performed in the U.S. annually, nearly 3.5 million report abnormal results. Of these, more than two million women are referred for colposcopy or cervical biopsy. Despite potential complications associated with these procedures, only about 20 percent yield medically actionable results—indicating that the majority of these more invasive procedures may have been unnecessary. Cancer Genetics believes that their non-invasive FHACT test, which is performed on the same specimen collected during routine women’s health exams (Pap smear tests), will aid in reducing unnecessary colposcopies and cervical biopsies and help reduce complications and costs associated with overtreatment. Learn more about FHACT.