NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services, announced today an expansion of its comprehensive FISH (Fluorescence In Situ Hybridization) testing menu to include a new NeoSITE Cervical assay to provide additional diagnostic information on abnormal Pap smears.
Using FISH technology, the NeoSITE Cervical assay evaluates abnormalities in five chromosomal loci. This is the most comprehensive genomic test available to evaluate abnormal Pap smear samples. This testing can be used for diagnosis, for prediction of prognosis, and for monitoring precancerous and cancerous cervical lesions. NeoSITE Cervical is designed as a complementary test to the cytology examination and HPV testing.
It is estimated that 29.4 million Pap tests are ordered annually in the US. 3%-5% of all tested cases are classified as ASCUS (Atypical Squamous Cells of Undetermined Significance) and another 3%-5% are reported as low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) or cervical intraepithelial neoplasia (CIN).
Abnormal cytology causes significant concern and anxiety for patients and physicians. Most of these cases carry low risk of Cervical Intraepithelial Neoplasia Stage III (a premalignant condition that is indicative of higher risk of cervical cancer), especially when not associated with HPV-positivity. However, one-third of abnormal cytology samples are associated with HPV and need to be monitored and managed carefully. ASCUS, LSIL, HSIL and CIN may regress or progress. Using biomarkers to objectively determine the exact classification, prognosis and to monitor progression or regression can be very helpful in managing these patients.
Douglas VanOort, NeoGenomics' Chairman and Chief Executive Officer, stated "Expanding our genomic testing to cytology represents a major growth initiative in our business. More importantly, we believe that we can improve patient care and provide more precise diagnosis by introducing this comprehensive genomic testing to this segment of cancer testing."
Dr. Maher Albitar, the Company's Chief Medical Officer and Director of Research and Development, commented "HPV testing has improved the prediction of the presence of cervical cancer. However, large chromosomal gains and losses are the major biomarkers and perhaps underlying cause responsible for the malignant transformation in cervical cancer and in solid tumors as a whole. Our testing of 5 chromosomal loci is a comprehensive and practical approach to directly evaluate core abnormalities in the cancer cells."
The new NeoSITE Cervical FISH assay is currently available as a global (professional and technical component) and technical-component-only assay.