Keratin 17: A Specific Marker for the Classification of High-grade Cervical Intraepithelial Neoplasia and Carcinoma

Identification of a molecular marker that can be used to diagnose cervical pre-maliganat lesions that precede cervical cancer and predicts the survival of patients with cervical cancer. Background: Although HPV status and p 16/Ki67 are powerful diagnostic adjuncts for the histologic classification of cervical neoplasia; they provide limited information regarding disease regression, persistence, or progression. It was recently discovered that Keratin 17 is a specific molecular marker for cervical high-grade intraepithelial lesion and cervical carcinomas in histologic sections. Technology Overview: Dr. Kenneth Shroyer, Doctor of Medicine at Stony Brook University identified and validated a molecular marker that may improve the accuracy in the diagnosis of cervical pre-malignant lesions that precede cervical cancer. This marker was validated in tissue samples of patients, and currently the research group is validating Kl7 in cytology samples (Pap smears). In addition, the investigators determined that high levels of Kl7 expression in cervical cancer correlates with poor survival, independent of tumor grade. Thus, K17 may have a role in improving the diagnostic accuracy of pre-malignant cervical lesions and to predict survival of patients? with cervical cancer. Advantages: Highly specific and sensitive molecular biomarker. Distinguishes HSIL and SCC from LSIL and normal cervical mucosa. Predicts survival of SCC patients. Applications: diagnostic of cervical pre-maliganat lesions that precede cervical cancer. Predict the survival of patients with cervical cancer. Intellectual Property Summary: PCT Publication No. WO 2015-021346 Stage of Development: Clinical development Licensing Potential: Available for licensing Licensing Status: Available for License Additional Information: Keratin, High-grade cervical intraepithelial neoplasia, HSIL, Cervical squamous cell carcinoma, SCC
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