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Frost & Sullivan Lauds IncellDx for Developing a Novel, Non-invasive Method for Cervical Cancer Testing

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Frost & Sullivan Lauds IncellDx for Developing a Novel, Non-invasive Method for Cervical Cancer Testing PR Newswire MOUNTAIN VIEW, California, Sept. 11, 2012 - 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.
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Frost & Sullivan Lauds IncellDx for Developing a Novel, Non-invasive Method for Cervical Cancer Testing
PR Newswire MOUNTAIN VIEW, California, Sept. 11, 2012
- 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