Xagenic Inc. reports that the Beta version of its fully automated X1TM molecular diagnostic testing system has undergone successful testing at an external clinical site. The first assay developed for the system is a combined chlamydia and gonorrhoea (CT/NG) test that is designed to facilitate screening, diagnosis and rapid treatment of these sexually-transmitted diseases.
The X1 system is intended for physician office use, with minimal hands on time (< 1 minute) needed to run a test, and a definitive test result is generated within a typical office consult. The external study confirmed the feasibility of point-of-care testing using the X1 system, and that the X1 CT/NG test was able to generate testing results comparable to gold-standard molecular tests run at centralized labs.
The X1 testing system automates all aspects of sample processing and analysis. A user introduces a sample into the disposable cartridge, inserts the cartridge into the testing system and starts a test. No incubation or sample extraction steps are required. Use of the system by clinical personnel was shown to be straightforward during the recent study, and very low rates of user errors were observed.
The Xagenic AuRATM technology is a unique direct detection approach that leverages electrochemical signal amplification to eliminate the need for enzymatic amplification. “Eliminating enzymes” says Shana Kelley, the Chief Executive Officer of Xagenic, “gives us the ability to produce a simple, user-friendly, and cost-effective consumable for decentralized molecular testing.” The detection technology used for infectious disease testing by Xagenic, in addition to possessing sensitivity on par with enzymatic amplification strategies, is highly versatile. It can be adapted to the analysis of protein analytes and small molecules, and has also been shown to be effective for the analysis of cell-free circulating nucleic acids for liquid biopsy applications.
“We are very excited about the progress of the X1 testing system and demonstrating its clinical utility during Beta testing. The information we have collected will inform the completion of the final design for the X1 and the development of menu for this first-in-class POC molecular testing system,” says Xagenic’s Chief Operating Officer Randall Wilhoite.
CT/NG was selected by Xagenic as the lead assay for the X1 platform because of the clinical utility of POC screening for these indications. Sexually-transmitted infections (STIs) like CT and NG can be asymptomatic, but cause significant complications including infertility. Last month, the US Centers for Disease Control and Prevention reported that rates of these infections continued to rise for the second year in a row, and commented that progress in the fight against STIs has “unraveled”. Having the Xagenic X1 testing system in place to diagnose CT and NG infections rapidly will provide physicians with a new tool to combat this public health threat.
Xagenic plans to complete work on the clinical- and commercial-grade X1 testing system in early 2017 and initiate a clinical trial for FDA approval by mid-year.
Xagenic is a privately-held molecular diagnostics company developing the X1™ platform, a revolutionary diagnostic system designed from its inception for point-of-care use. The Xagenic X1 platform will allow users to perform lab-quality molecular diagnostic tests in the physician office. With a time-to-result of 20 minutes, the system is poised to transform the way healthcare is delivered. The Company is backed by Domain Associates, CTI Life Sciences Fund, the Ontario Capital Growth Corporation, and BDC Capital. Xagenic was the 2014 Frost & Sullivan Point-of-Care Diagnostics New Product Innovation Leadership Award winner and the recipient of the 2015 Life Science Company of the Year award from Life Sciences Ontario. The Company is headquartered in Toronto. For more information, please visit www.xagenic.com.
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Last updated on: 10/11/2016
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