Method to identify and predict disease progression of human papilloma virus-infected lesions

Description: Human papillomavirus (HPV) infection is the major risk factor for the development of cervical cancer. The CDC estimates that 80% of women will acquire HPV at some point in their life.

The majority of women that develop cervical HPV improve. HPV becomes undetectable within a year of acquiring the infection. About 10% of women that get HPV cannot contain the infection and develop a precancerous cervical lesion within 2-years.  While only a small percent of women will actually develop precancerous lesions or cervical cancer, a major problem is the inability to predict which women of the millions of new HPV cases diagnosed each year will progress. This limitation causes HPV infected women to be followed in yearly surveillance programs. This affects women, as physicians can’t definitively tell them their infection will regress. In addition, billions of dollars are spent managing HPV infected patients.

Dr. Castellanos’ new method to process cervical biopsies identifies HPV lesions that are undergoing malignant transformation. The staining method is based on the fact that viral particles are only found in benign HPV infected lesion. Cells undergoing cancerous changes are not able to support the life-cycle of HPV and therefore do not produce mature viral particles. The staining method is able to identify these changes and mark lesions that are likely to progress.

With the patented VIRION-Associated HPV stain, Dr. Castellanos hopes to build a partnership to develop the concept and create a staining kit. The new method aims at reducing colposcopy evaluation by better predicting which women are truly at risk to develop a precancerous lesion, once HPV is identified.

Area of Application: Human papillomavirus infection and associated cancers, Diagnostic Pathology

Lead Investigator: Mario R. Castellanos, MD

Patent Info: US Patent No. 8,586,296, Issued November 19, 2013

References: Castellanos MR, et al. “Endonuclease Resistant DNA: A Novel Histochemical Marker for Cervical Intraepithelial Neoplasia and Cervical Carcinoma”. Int J Gynecol Pathol. 2012;31(1):1-7.

Licensing Contact:
Kirk R. Manogue, PhD
Director, Office of Technology Transfer

350 Community Drive
Manhasset, New York 11030
Phone: (516) 562-3404
Fax: (516) 562-2356