TORONTO, ON-Xagenic Inc. reports that the Beta version of its fully automated X1™ 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.
According to the company, the system automates all aspects of sample processing and analysis. The way it works is 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. The company says that 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 AuRA™ technology is a unique direct detection approach that leverages electrochemical signal amplification to eliminate the need for enzymatic amplification.
“Eliminating enzymes gives us the ability to produce a simple, user-friendly, and cost-effective consumable for decentralized molecular testing,” says Shana Kelley, CEO of Xagenic.
She adds that 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,” says Randall Wilhoite, Xagenic’s chief operating officer. “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.”
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.