Diagnostics & Imaging Week

CytoCore (Chicago) reported that it is launching a Phase I trial to begin this month for a "quick, accurate, inexpensive" screening test for endometrial and uterine cancers that it believes could change the lives of women with those cancers, or at risk for them, much the way Pap smears did for cervical cancer beginning in the 1960s.

The test, the InPath system, will rely on a specialized computer-guided image recognition microscope system and the new P2X7 genetic marker to identify precancerous cell changes.

"Some 40% of American women between the ages of 35 and 70 exhibit risk factors for endometrial or uterine cancer such as obesity, hypertension, diabetes or family history," said Steven Waggoner, MD, a gynecological oncologist and member of CytoCore's medical advisory board. "CytoCore's new screening test has a potential target population of between 25 and 28 million women in the United States alone."

The P2X7 genetic marker was discovered by George Gorodeski, MD, of University Hospital Case Medical Center (Cleveland; formerly University Hospitals of Cleveland), who is leading CytoCore's effort to bring the early detection test to fruition.

Gorodeski explains the accuracy of the biomarker in an article appearing this month in the American Association for Cancer Research's journal, Cancer Epidemiology Biomarkers & Prevention.

"Dr. Gorodeski has been involved with this company as a vehicle for commercializing his discoveries for six years," Gene Martineau, communications and business development consultant for CytoCore, told Diagnostics & Imaging Week. "There was an interim period when that relationship was non-functional for three to four years. But it has come back together since the investor group took over the company and basically brought in new management and money and turned it around."

Gorodeski's study demonstrates that the P2X7 biomarker has an "unusually high degree of accuracy" for the detection of uterine epithelial cancers. Studies to date have shown sensitivity of 92% to 100% and specificity between 90% and 100%.

CytoCore said that the P2X7 protein is a down-regulated biomarker, meaning that when it is diminished, the presence of cancer or dysplasia is likely. Preliminary laboratory testing on the marker "suggests that it may be a genetic mechanism that controls the apoptosis, or cell death process, in epithelial cells."

The InPath system for uterine cancer consists of three components: a "newly designed endometrial [cell] collector," slide-based biochemical assays and the Automated Imaging Proteomic System (AIPS).

The endometrial collector, using a long, thin catheter, injects saline solution into the uterus, flushing out the cells in the uterus into the collector. Those cells are then deposited into a preservative, which is later put into a centrifuge to draw out the cells and add those to a slide. That slide is exposed to two markers, including the P2X7 biomarker. CytoCore's biomarker will show "which of those epithelial cells are downgraded" due to the presence of P2X7. The AIPS device allows the biomarkers to "fluorescently tag these cells."

Martineau told D&IW that after the conclusion of the Phase I trial of the endometrial cancer scan — expected in about six months — the company hopes to go to market with the test under the FDA's analyte specific reagent (ASR) guidance in "one or more" CLIA labs. Phase II tests will not be completed until about two years from now, at which point CytoCore hopes to go before the FDA for the system.

Gorodeski and his team, whose research was funded by grants from the National Institutes of Health and the American Heart Association (Dallas), performed comparative experiments on common epithelial uterine cancers that comprise more than 95% of all uterine cancers and found their results were "consistent," the company said.

Uterine cancer will be diagnosed in some 41,200 women in the U.S. this year, making it the fourth leading cancer among women, compared with about 9,700 cases of cervical cancer, according to the American Cancer Society (Atlanta), CytoCore said.

Unpublished preliminary studies "suggest similar levels of accuracy" in skin, breast and prostate tissue analyses, CytoCore said.

CytoCore, formerly known as Molecular Diagnostics, has spent the last year "cleaning up [its] financials," Martineau said, noting that it is "definitely a new chapter for the company," which reported in August that its restructuring was complete.

"We literally closed the book on the process of the turnaround, and we're moving forward as aggressively as we can," he said. "We're just picking up steam."

Gorodeski rejoined the company's efforts in October 2005, and he brought to the company two new products, the P2X7 biomarker and "a variation on the e2 Collector device which is a drug delivery device."

Gorodeski also arranged for CytoCore to co-locate its research lab at University Hospitals along with his own lab, Martineau said.

CytoCore has sufficient capital to take it through Q107, and it is going to be raising additional funding, he said.

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