NeoSITE Cervical FISH Assay by NeoGenomics Enhances Cervical Cancer Diagnostics for Abnormal Pap Tests

NeoSITE Cervical FISH Assay by NeoGenomics Enhances Cervical Cancer Diagnostics for Abnormal Pap Tests

NeoGenomics recently announced it has begun to expand its extensive FISH (Fluorescence In Situ Hybridization) range of services by also offering a novel NeoSITE Cervical assay to improve diagnostic patient data obtained from abnormal Pap smears.

Using FISH, this new cervical assay can detect pap smear abnormalities in 5 loci on chromosomes, making it the most all-inclusive genetic test compatible with pap smears, capable of providing improved diagnostic information along with predictive prognosis, and lesion monitoring. The NeoSITE Cervical assay was designed to be bundled with traditional cytology exams and tests for HPV.

Today, almost 29.4 million Pap smear tests are performed every year in the United States. Estimates show that of this number, 3 to 5% are diagnosed as ASCUS (Atypical Squamous Cells of Undetermined Significance), while another 3 to 5 percent are classified as low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) or cervical intraepithelial neoplasia (CIN). All of these classifications can either regress or progress.

These abnormal classifications tend to cause anxiety for both patient and health provider, despite the fact that most of these test results reveal low risk of Cervical Intraepithelial Neoplasia Stage III, a precancerous condition that only indicates an elevated risk of cervical cancer. What physicians should be on the alert for, however, is the number of abnormal cytology results that have HPV-positivity, which warrant careful monitoring and management. By using biomarkers, diagnosing cervical cancer can help in accuracy and ultimately relieve unnecessary patient-provider tension over more manageable test results.

NeoGenomics Chairman and Chief Executive Officer, Douglas VanOort, said, “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, added, “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.”

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