- IncellDx's OncoTect 3Dx™ screening test has the potential to become the gold standard for gynecological care
MOUNTAIN VIEW, California, Sept. 11, 2012 /PRNewswire/ -- Based on its recent analysis of the molecular diagnostics market, Frost & Sullivan recognizes IncellDx with the 2012 North American Frost & Sullivan Award for Product Leadership for its pioneering cervical cancer testing technology, a methodology which holds the promise of decreasing the number of unnecessary, painful, and expensive invasive testing procedures. Numerous clinical studies evaluating the company's HPV OncoTect® technology have demonstrated similar sensitivity but much greater specificity for cervical disease than traditional screening processes. Additionally, the core technology holds great promise as a diagnostic test for breast cancer, doing away with the need for more invasive surgical biopsies.
IncellDx's innovative technology aids in the analysis of intact cells using flow or image cytometry after the target protein, DNA, or RNA biomarkers within the cell are bound by labels.
"The cornerstone of IncellDx's revolutionary approach is its proprietary incellFP reagent, which allows for a one-step fixation/permeabilization," says Frost & Sullivan Global Program Manager Jennifer Brice. "The incellFP reagent fixes and permeabilizes the outer cell and nuclear membranes, permitting in situ probe hybridization without destroying prior antibody labeling of cell surface markers."
In 2011, the U.S. Preventive Services Task Force issued new cervical cancer screening recommendations that discouraged the use of human papillomavirus (HPV) screens in young women, since they are more likely to have HPV infections that clear on their own. These recommendations aimed to reduce the number of false positives thrown up by Pap and HPV tests—an issue well-addressed by IncellDx's HPV OncoTect® methodology. The technology is designed to have similar sensitivity to, but much higher specificity than, current high-risk HPV genotyping technologies.
When HPV infections progress towards cervical cancer they integrate into the patient's host genome which causes HPV E6, E7 mRNA to be over-expressed. Frost & Sullivan's competitive benchmarking reveals that IncellDx's HPV OncoTect® methodology has a unique and powerful approach to the detection and quantification of E6 and E7 mRNA inside each collected cervical cell.
"Unlike other molecular diagnostic technologies that are limited to detecting high-risk HPV infections off of genomic material extracted from lysed cervical cells, IncellDx's patented technology is able to keep the target cervical cells intact and thereby quantify the actual E6, E7 mRNA overexpression in each and every cell," observes Brice. "Studies have shown that the HPV OncoTect® technology is much more predictive of actionable cervical disease than screening for high-risk HPV."
In the near future Frost & Sullivan expects OncoTect 3DxTM to transform the traditional Pap based cytopathology laboratory. With the addition of image cytometry, 3DxTM adds the morphological analysis routinely done in a Pap test to the molecular analysis from the OncoTect® method. Once commercially available this technology will enable laboratories to retire their microscopes for cervical cancer screening and completely digitize their cytopathology testing.
"With as many as 60 million Pap tests analyzed in the U.S. annually, IncellDx's technology could supplant an entire $2 billion Pap screening industry," observes Brice. "And in countries such as China, where the required infrastructure for widespread Pap screening does not even exist, OncoTect 3DxTM could easily become the primary approach to cervical cancer screening."
Looking forward, IncellDx can leverage its burgeoning relationships with many of the world's largest reference laboratories to ensure continued excellence in strategy and operations.
Each year, Frost & Sullivan presents this award to the company that has demonstrated innovation in product features and functionality, and that provides enhanced quality and higher value to customers. The award recognizes the rapid acceptance such innovation finds in the marketplace.
Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.
IncellDx, Inc. is a molecular diagnostics company dedicated to the detection and monitoring of life threatening diseases such as cervical cancer, breast cancer, HIV/AIDs, hepatitis, and organ transplant rejection.
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