The Beta version of Xagenic’s fully automated X1TM molecular diagnostic system has undergone successful testing at an external clinical site.
A combined chlamydia and gonorrhoea (CT/NG) test was the first assay developed for the system.
According to Xagenic, the test was designed to support screening, diagnosis and rapid treatment of sexually-transmitted diseases.
Intended to be used by physicians, the X1 system has minimal hands on time of less than one minute to carry out a test besides generating a definitive result in quick time.
Xagenic COO Randall Wilhoite said: “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.”
The clinical and commercial quality X1 testing system is slated to be ready by early 2017 before it is applied for an FDA approval by mid-year.
In its external clinical study, the point-of-care testing using the X1 system has been confirmed to be feasible. Additionally the CT/NG test could generate testing results on par with gold-standard molecular tests in centralized labs.
Through the X1 testing system, sample processing and analysis aspects are completely automated as per its manufacturer.
Based on a direct detection approach, the X1TM uses electrochemical signal amplification and thereby rules out any need for enzymatic amplification.
Xagenic CEO Shana Kelley said that a simple, user-friendly and cost-effective decentralized molecular testing consumable can be produced through enzymes elimination.
The X1 testing system has the potential to analyze protein analytes and small molecules besides being effective for the analysis of cell-free circulating nucleic acids that are used for liquid biopsy applications.