Federal funding and FDA Emergency Use Authorization streamlined development and commercialization of these new assays.
As the COVID-19 pandemic swept across the globe, people everywhere have raced to respond. The Luminex team has been working around the clock on much-needed molecular diagnostic assays for the SARS-CoV-2 virus, two of which recently received Emergency Use Authorization from the FDA.
Why not focus on one assay instead? As we see it, labs around the world need as many types of diagnostic tests as possible to address this pandemic, and it is crucial to get these new tests up and running quickly. Many can’t spare the time it would take to evaluate and install an entirely new diagnostic platform.
That’s why we developed assays for two of our most popular platforms, which are already in use in labs all around the world. The ARIES® SARS-CoV-2 Assay runs on our FDA-cleared, automated sample-to-answer ARIES® System, which is designed for moderate-complexity labs and generates results in about two hours. The ARIES® System can run up to 144 tests per day, requiring no specialty training and minimal human interaction. We also launched the NxTAG® CoV Extended Panel, which is a high-throughput, scalable, cost-effective option for detecting SARS-CoV-2 in up to 96 samples in approximately four hours. The NxTAG CoV Extended Panel, which can be run on our compact MAGPIX® System, can also be used in parallel with the NxTAG® Respiratory Pathogen Panel to provide a more complete picture of a patient’s respiratory health. The MAGPIX System can run more than 500 tests per day.
It’s important to note that we didn’t do this alone. Luminex is very grateful to have received support from the Biomedical Advanced Research and Development Authority—part of the US Department of Health and Human Services. Each of our new SARS-CoV-2 tests was supported with a BARDA contract for $642,450.
In a statement announcing this news, Luminex CEO and President Nachum “Homi” Shamir said: “We are partnering with our customers at clinical laboratories to address the global pandemic, providing fast, reliable, scalable, multiplex tests that can help stem the spread of COVID-19 disease, while also ensuring that our tests are cost-effective.”
Sherry Dunbar, PhD, MBA, is the Senior Director of Global Scientific Affairs at Luminex.
The NxTAG CoV Extended Panel and the ARIES® SARS-CoV-2 Assay have each been funded with $642,450 of Federal funds, approximately 36% each of the expected overall cost of development, from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract Nos. 75A50120C00037 (NxTAG CoV Extended Panel) and 75A50120C00043 (ARIES® SARS-CoV-2 Assay). Luminex financed the remaining $1,118,663 of each program, constituting 64% each of the total program costs.
- Luminex Diagnostic COVID-19 Offerings [Webpage]
- xMAP® Technology for Multiplex COVID-19 Serology Assays [Webpage]
- Considerations Regarding RNA Extraction Kits for SARS-CoV-2 Detection [Blog]
- How Luminex Is Supporting Research Partners’ Pandemic Response [Blog]
- Questions to Ask When Choosing a Multiplex Assay Kit[Blog]