“We have been working on multiple solutions to augment our NxTAG and ARIES offerings in order to facilitate and automate the detection of SARS-CoV-2,” said Nachum “Homi” Shamir, President and CEO of Luminex. “These additional alternatives leverage our globally available instrument platforms and assay technologies. They should be especially helpful to laboratories throughout the United States, given the recently released guidance from the Food and Drug Administration concerning high-complexity testing under CLIA prior to Emergency Use Authorization (EUA) for SARS-CoV-2.”
Luminex anticipates making two different solutions available for SARS-CoV-2 testing:
- NxTAG® CoV Expanded Panel. Luminex has developed a unique multiplex panel that addresses the current coronavirus outbreak using its existing bead-based NxTAG Technology. This expanded panel has undergone initial testing using samples at Chinese Center for Disease Control and Prevention (China CDC) locations. Early results seem very promising and the company expects to conclude this testing in the next several days. In addition, Luminex has begun validation in the United States at a number of existing customer facilities. This panel should be available to ship to customers in a few weeks, under the terms of the EUA listed above.
This expanded panel includes three gene targets for SARS-CoV-2 (ORF, E-gene, and N-gene), as well as SARS-CoV and MERS-CoV, and will be the first assay panel globally that will be able to simultaneously test for each of these coronavirus strains. Luminex’s NxTAG® Respiratory Pathogen Panel (RPP), which was cleared by the FDA and other worldwide agencies more than four years ago, can be run in parallel with the expanded outbreak panel to identify and/or rule out both existing and novel respiratory infections. The existing RPP test and this new expanded panel are both plate-based, high-throughput, low-cost solutions that run on the MAGPIX® instrument. This combination of assays offers labs an ideal solution for their anticipated high-volume testing of respiratory infections, including both flu and other coronaviruses.
- SARS-CoV-2 Target on ARIES®. In addition, Luminex has evaluated a single-target test on the ARIES® System for SARS-CoV-2. The company has had two European reference labs successfully validate a multi-targeted test using the ARIES® System and are also currently validating the test with customers in the United States. ARIES® uses real-time PCR technology that, when combined with its ability to run laboratory developed tests (LDTs), is ideally suited for situations such as the current pandemic. This SARS-CoV-2 target incorporates the latest U.S. Centers for Disease Control and Prevention (CDC) primer sequences and is currently available to customers who use the ARIES® System. This testing can be validated by qualifying laboratories under the aforementioned EUA path. The ARIES® System currently has seven FDA cleared assays, including Flu A/B & RSV.
“Offering multiple solutions is a key part of Luminex’s focus on providing value and flexibility to our current and future customers,” said Shamir. “The assays we are working on will assist both laboratories and clinicians that need to detect SARS-CoV-2 on its own, as well as those that may need a more complete picture of potential causes of respiratory infections—including targets that are both common and novel in nature. In addition, Luminex’s VERIGENE® RP Flex Test, NxTAG RPP, and ARIES® Flu A/B & RSV assays are all able to provide exclusion testing as laboratories grapple with the emerging COVID-19 situation during the flu/respiratory season. Given the expanding scope of this outbreak, it seems likely that we could be battling COVID-19 for the foreseeable future.
“We are unable to quantify at this time what, if any, material financial impact these efforts will have, and are not making any adjustments to our current expectations. We look forward to providing additional updates as they become available,” said Shamir.