The global COVID-19 pandemic crisis has reinforced the critical role of rapid, accurate diagnostics. From helping to minimise community transmission, to reducing pressure on already-burdened healthcare systems, public health authorities have realised that reliable, accessible, and fast diagnostics are an important factor in managing pandemics.
At Ellume, we are committed to developing high-quality digital diagnostics that can be relied on in a health crisis.
Leveraging our infectious disease expertise, we are developing the following categories of COVID-19 products:
COVID Home Test for the consumer market
A COVID home test that allows patients to take a test without leaving their homes offers substantial benefits to countries with significant COVID-19 burden:
- enable broader testing
- minimise community transmissions
- relieve existing, overwhelmed testing infrastructure
- limit close contact of front-line health care professionals with infected patients
- preserve critical personal protective equipment
Keeping the new COVID-19 Home Test as close to our Home Flu Test as possible, we are hoping to accelerate development and regulatory timelines and are looking to launch in the USA in the first half of 2021.*
*Not available in Australia.
Access COVID antibody serology test for the laboratory market
In conjunction with global diagnostics company QIAGEN, Ellume has developed a COVID antibody test on the QIAGEN Access platform, initially developed for latent Tuberculosis (TB) detection.
Access Anti-SARS-CoV-2 Total is a high-performance antibody test for recent or past COVID-19. This test has been submitted for US FDA Emergency Use Authorisation.
The test is run on the Access eHub, an easy-to-use and portable digital device that provides results in 10minutes.
ellume·lab COVID serology tests and COVID antigen tests for the healthcare professional market
ellume·lab is a hand-held, versatile digital device designed for healthcare professionals and practitioners. ellume·lab will launch in the USA as the only point-of-care, rapid, immunoassay-based testing platform offering both a COVID serology test (for recent or past infections) and a COVID antigen test (for active infections) on the same device.
Two tests can be performed simultaneously, allowing clinics to increase testing efficiency. Both tests are easy to use due to simple, interactive, on-screen instructions and feature rapid time to result of less than 15 minutes. Both COVID tests are undergoing clinical validation in a CLIA-waived setting.
Swap+Drop COVID-19 Self-Swab Kit
We have previously developed a self-swab which has been validated as part of our Home Flu Test program. This swab kit is now being prepared for launch as a stand-alone product to enable users to collect their own sample which will then undergo testing at a laboratory.
This product is called ‘swab+drop’ and will support rapid screening at collection centres.
The Ellume swap+drop Self-Swab Kit has been listed on the Australian Register of Therapeutic Goods. We endeavour to work with pathology laboratories to make this product available to Australian patients in the coming months.