Ellume announces high-performance test for active COVID-19 infection

Digital diagnostics firm Ellume Ltd (Ellume or “the Company**”**) has extended its strategic partnership with leading global life sciences and diagnostics company, Qiagen NV (NYSE: QGEN), announcing the development of a rapid, high-performance SARS-CoV-2 antigen test, for active COVID-19 infection, on the QIAGEN QIAreach™ platform. The antigen test complements the previously announced Anti-SARS-CoV-2 Total antibody test for past exposure to SARS-CoV-2. The products serve to address the unprecedented global demand for rapid, accurate diagnostic tests for infection with the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the virus which causes COVID-19.

QIAreach™ Anti-SARS-CoV-2 Antigen Test, is a rapid, portable test that can detect SARS-CoV-2 antigens in people with active infections using nasal samples. Like the Anti-SARS-CoV-2 antibody test, the antigen test is run on the QIAreach™ eHub, an easy-to-use and portable digital device that provides reliable results in less than 15 minutes – and in as little as 3 minutes in the case of a strong positive. The accuracy and speed of the test is made possible by Ellume’s patented Quantum Dot and reader technology.

Ellume CEO, Dr Sean Parsons said, “The QIAreach™ eHub platform offers a new combination of speed and scale that marks an important step towards decentralised mass testing that health authorities all over the world have been urgently seeking.”

Each eHub handles up to 8 patient samples, can process over 30 samples per hour and both antigen and antibody tests can be run simultaneously. Multiple eHubs can be located at high demand sites with minimal cost. This will enable laboratories to run tests to detect both previous and active infections on one device at the same time – with each testing slot operating independently of the others.  Knowledge of past and present infections is essential to understanding and inhibiting the spread of the disease.

“The QIAreach™ Antigen Test is fast, easy to use and cost-effective and will be a valuable tool to address the so far unmet high-volume testing needs for SARS-CoV-2 antigens in situations where time is of the essence,” said Thierry Bernard, Chief Executive Officer of QIAGEN.

Feasibility tests have shown the QIAreach™ Antigen Test to have a sensitivity of at least 90% in symptomatic patients and a specificity of 100%. QIAGEN will apply for FDA Emergency Use Authorization and seek CE-IVD registration in Europe. A CLIA Waiver in the U.S. would allow the point-of-care (POC) version to be used in settings like airports, schools or stadiums.

The relationship further strengthens Ellume’s existing global partnership with QIAGEN on the detection of latent tuberculosis infections. The QIAreach™ QuantiFERON®-TB (QIAreach™ QFT), pairs Ellume’s ultrasensitive digital detection of latent TB infection with a complete testing workflow designed for cost-efficiency and ease of use.

ENDS