By Ron Shinkman, Editor, Laboratory Industry Report
Florida-based molecular laboratory NeoGenomics has introduced a new test focused on providing more diagnostic information for women who have abnormal pap smears.
The test, known as the NeoSITE Cervical Assay, is an expansion of NeoGenomics’ FISH testing menu. It will focus on abnormalities in five chromosomal locations. The test can be used for monitoring cancerous and precancerous lesions, as well as diagnosis and prognostic predictions.
"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,” said Maher Albitar, M.D., NeoGenomics’ chief medical officer and director of research and development. “Our testing of five chromosomal loci is a comprehensive and practical approach to directly evaluate core abnormalities in the cancer cells."
The market for the new test could be considerable. There are about 29.4 million Pap smears performed in the U.S. annually, and up to 10 percent have abnormal readings, including indications for atypical squamous cells, low-grade and high-grade squamous intraepithelial lesions, and cervical intraepithelial neoplasia (CIN).
“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,” NeoGenomics Chief Executive Officer Douglas VanOort said in a statement.
A retail price for the new test was not released.