Chicago-based CytoCore Inc. announced on Thursday “plans to begin trials for a quick, accurate, inexpensive screening test for endometrial and uterine cancers using a specialized computer-guided image recognition microscope system and the new P2X7 genetic marker to identify pre-cancerous cell changes.” Company’s technology is based on recently discovered P2X7 biomarker that is involved in the apoptotic pathway of human epithelial cells, according to the company. Besides the biomarker, CytoCore’s diagnostic technology also utilizes a specialized computer-guided image recognition microscope system, and a special endo-cervical cell collector.
From the press release:
CytoCore’s new test, which Dr. Gorodeski said is about to begin clinical trials at UHCMC and other medical centers, is quick and minimally invasive. A newly designed “endometrial collector” gathers endometrial cells from the uterus with a flushing process that rinses and collects a saline solution through a thin catheter introduced into the uterus. The collected cells are then placed in a preservative solution and sent to a lab, where they are tested for the expression of two markers, including the definitive P2X7 biomarker.
CytoCore’s AIPS (Automated Image Proteomic System), a computer guided image recognition microscope system, uses fluorescence to tag and locate any positive cells out of the thousands screened in a typical lab sample. The company has applied for a patent request for its Endometrial Cancer Scan process, which includes the biomarker and the flushing method for cell collection.
Company explains purported power of its patented biomarker:
The initial lab results for P2X7 showed excellent sensitivity and specificity (measures of biomarker accuracy) in detecting both cervical and endometrial (uterine) cancers. This is a groundbreaking opportunity in the area of endometrial cancer detection because an effective screening test for endometrial cancer and its abnormal bleeding condition (8-15% of women report this condition) does not exist. Invasive biopsy followed by histological evaluation by a pathologist is currently the only option for women being tested for endometrial cancer. The Cocktail-GCITM assay could therefore be potentially used as a screening method for endometrial cancer in women.
Preliminary studies also suggest that the P2X7 biomarker accurately identifies apoptotic deficiencies in other types of epithelial cells. The use of th P2X7 biomarker in conjunction with EGFR opens up the possibility of creating new assays to detect other forms of cancer. CytoCore will be testing its existing cocktail formulations to see if they can also be used to identify skin, bladder, breast, prostate, and lung cancers.