Versatile rapid diagnostic platform receives CE mark

AnteoTech has announced that its EuGeni Reader and accompanying COVID-19 Antigen Rapid Test (ART) have received CE mark registration as the company looks to progress with European distribution.

The digital multi-test EuGeni Reader aims to eliminate the human error associated with current lateral flow test interpretation and can support high-sensitivity quantitative readouts for time-critical disease and clinical intervention tracking. The COVID-19 ART boasts strong sensitivity and specificity, and delivers test results in less than 15 minutes. As such, it will be a key tool to support efficient front-line screening as economies look to reopen across the continent. A first-of-its-kind, ultra-high-sensitivity COVID-19 saliva test is the next of a suite of tests being developed for the EuGeni Reader.

AnteoTech’s EuGeni Platform is a highly interactive, user-friendly reader system underpinned by patented AnteoBind nanoparticle technology, offering exceptional test sensitivity and specificity. The first test to leverage the platform – AnteoTech’s COVID-19 ART – has demonstrated 97.3% sensitivity and 99.6% specificity in clinical studies, enables on-the-spot identification of persons with suspected COVID-19 infection, and can be processed at 60 tests per hour using the EuGeni Reader. Such capabilities make it an unmatched solution for swift mass screening in critical industries, including healthcare, public events, and travel.

Derek Thomson, chief executive officer of AnteoTech, said: "Receiving CE certification for EuGeni is a momentous step towards meeting an urgent global need for high-sensitivity, high-specificity rapid testing technology. As we are rapidly finalising deals with distribution partners to facilitate large-scale rollout of our COVID-19 ART across Europe in the coming weeks, we’re continuing to refine and mature a promising selection of rapid tests in other disease areas that provide immense value – the next being an exceptionally sensitive COVID-19 saliva test."

AnteoTech’s rapid COVID-19 saliva test is undergoing clinical studies and aims to offer significantly higher sensitivity than seen in currently available COVID-19 saliva tests. Validating the COVID-19 ART for saliva use will further increase the test’s ease of use and implementation speed, as well as reducing invasiveness for improved patient comfort. These features will broaden the applicability of the test to a range of new screening contexts.

Among a selection of tests also in development for EuGeni are a multiplex COVID-19/Flu A & B test, and a quantitative multiplex rapid sepsis test. With early detection and close-to-real-time biomarker tracking capabilities, the sepsis test and EuGeni Reader will offer significant value, as sepsis is often fatal in later stages, but highly treatable when detected early and carefully monitored.

By leveraging quantitative detection algorithms, the EuGeni Reader aims to eliminate the ambiguity of results interpretation encountered with lateral flow tests, especially when dealing with very small amounts of target antigen. The system can also be smoothly integrated into electronic patient record systems and Laboratory Information Management Systems (LIMS) for optimised workflows free of manual data entry errors.