On-Q-ity Presents Performance Validation and Clinical Utility Data on Its Dual Capture OnQChip(TM)

Researchers Present Results at the American Association of Cancer Research (AACR) Annual Meeting


WALTHAM, Mass., April 2, 2012 (GLOBE NEWSWIRE) -- On-Q-ity, a life sciences company dedicated to providing the most accurate and actionable information possible across multiple cancers to enhance drug development and patient outcomes, today presented data validating its novel, dual-capture circulating tumor cell (CTC) platform technology. The OnQChip™, a size- and affinity-based CTC capture device, provides a highly sensitive, robust and efficient way to capture and detect CTCs from the blood of cancer patients. In addition, validation of the analytical performance of the On-Q-ity CTC platform enables assessment of clinical utility based on information obtained from captured CTCs and CTC fragments not found through standard measurement.  These laboratory results were presented at the AACR 103rd Annual Meeting, held in Chicago, IL, March 31-April 4.

The company is currently analyzing and characterizing CTCs in blood to identify cancer cells and gene mutations to provide drug developers and physicians with clear guidance for improved cancer diagnosis, treatment monitoring and earlier recurrence detection for their patients.

"The On-Q-ity CTC platform is redefining sensitivity," states Michael Stocum, President and Chief Executive Officer of On-Q-ity. "Not only can we improve the capture and detection of CTCs with OnQChip, but, by including our customized algorithms used with standard imaging systems, we are able to further enhance its sensitivity. The combination allows us to develop clinical utility by uncovering the critical cells and fragments that tell the unique characteristics of the patient's cancer.  This information is not captured by existing FDA cleared/approved products."

In a double blind study, using samples from cancer patients and healthy blood donors, researchers found that On-Q-ity's enhanced enumeration platform, combining size and affinity capture technology to detect a number of CTC classifications, was more sensitive than Veridex's CellSearch® in distinguishing cancer patients from normal donors. In this study, researchers found that the On-Q-ity enhanced enumeration platform was able to detect various CTC subtypes, including intact, irregular and fragmental CTCs, with greater sensitivity. These findings were based on the AUC (Area Under the Curve), which represents the ability of the test to correctly classify those samples with and those without the disease, and provided an AUC of 0.79 versus the CellSearch enumeration platform, which achieved an AUC of 0.65 in detecting intact CTCs.

In addition to validating the platform, scientists also demonstrated that the OnQChip has the unique ability to not only capture and detect EpCAM (epithelial cell adhesion molecule) positive CTCs, proteins most often associated with carcinomas, but EpCAM negative cells. Standard methods using affinity capture alone typically incorporate EpCAM antibodies to attract CTCs and hence, EpCAM negative cells often go undetected by standard enumeration techniques.

In a study using the size capture feature of the OnQChip along with novel EMT (epithelial to mesenchymal transition) detection markers, enumeration of EpCAM negative Hs578T cells spiked into blood was performed. Researchers found that the capture efficiency of the EpCAM negative cells with OnQChip was more than 70% when using the EMT detection markers. In contrast, using the standard CTC detection marker cytokeratin resulted in less than five percent capture of these EpCAM negative cells. 

"These data represent proof of concept for the On-Q-ity CTC platform and its potential to provide valuable information in the clinic," says Stocum. "Our next steps include ongoing studies that will further determine the versatility, utility and reproducibility of our system and its ability to characterize CTCs in order to provide important information to researchers and physicians to improve drug development and patient outcomes." 

AACR Poster Session: Finding and Understanding Circulating Tumor Cells  
Monday, April 2, 2012; 1:00 - 5:00 pm Central   
Poster #2389/22   
"A Microfluidic System for the Selection of Circulating Tumor Cells that Utilizes both Affinity and Size Capture Technologies"

About On-Q-ity

On-Q-ity is a life sciences company focused on novel circulating tumor cell (CTC) capture and characterization. We are developing products and services for clinical researchers and physicians that will enhance decision-making across multiple cancer types.  On-Q-ity envisions a time when cancer is transformed from a fatal to chronic disease via CTC technology, further enabling the promise of personalized medicine. Our goals are to increase the success of oncology drug development, improve patient treatment outcomes and increase survival rates. Headquartered in Waltham, MA, On-Q-ity is currently funded by Atlas Venture, Mohr Davidow and Physic Ventures. For more information visit our website: www.On-Q-ity.com.



            

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