- Ellume builds on existing partnership with global diagnostics company QIAGEN, to bring a rapid, reliable COVID antibody test to market
- QIAreach™ Anti-SARS-CoV-2 Total serology test has been submitted for US FDA Emergency Use Authorization
- 900,000 tests pre-ordered
Brisbane, Australia – 25 August 2020
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) with a high-performance COVID antibody test on the QIAGEN QIAreach™ platform. The product serves to address the unprecedented global demand for rapid, accurate diagnostic tests for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the virus which causes COVID-19.
QIAreach™ Anti-SARS-CoV-2 Total, is a high-performance serological test which detects antibodies in people who have been exposed to SARS-CoV-2. The test is run on the QIAreach™ eHub, an easy-to-use and portable digital device that provides reliable results in 10 minutes. Each eHub handles up to 8 patient samples simultaneously and performs up to 32 total tests per hour. The nanoparticle fluorescent detection technology uses serum or plasma from patient samples. In testing submitted to the FDA for Emergency Use Authorisation (EUA), the test had a sensitivity of 100% (CI 88.43–100.00%) and specificity of 100% (CI 95.20–100.00%) for all samples tested. Positive cases were sampled 14 days after first symptoms.
The test has been submitted for US FDA EUA, with CE-IVD marking anticipated in the coming weeks. With burgeoning demand for COVID tests, QIAGEN has placed a pre-order for 900,000 tests and the first batch of product has been shipped to QIAGEN in the USA.
“We are pleased to be extending our relationship with our longstanding partners, QIAGEN, in the fight against COVID-19. The QIAreach™ Anti-SARS-CoV-2 Total test offers a cost-effective COVID-19 testing solution to detect previous exposure to the virus,” said Dr Parsons.
Serological testing for antibodies is central to identifying people who have been recently infected by the virus or have been infected in the recent past, especially those who did not show any symptoms and therefore might not know of an infection. Understanding more about COVID-19 immunity in a population could help societies return faster to normal daily routines by informing and guiding public health measures such as contact tracing and individual measures under clinical guidance. Antibody testing could also become fundamental in supporting vaccine development as well as guiding, planning, and assessing future SARS-CoV-2 immunisation programs.
“Increased testing is the only way to gain visibility on the magnitude of the pandemic, which will ultimately lead to helping control it,” said Dr Davide Manissero, Chief Medical Officer at QIAGEN. “As a trusted partner in the fight against COVID-19, QIAGEN has now added the QIAreach™ Anti-SARS-CoV-2 to our portfolio as a smart solution for antibody testing that provides results with confidence. This is a rugged and portable platform that requires no hardware, can process a wide range of tests and provides fast results. We look forward to working with Ellume to discover and develop additional tests for this platform.”
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.