Luminex Receives FDA Emergency Use Authorization for COVID-19 Antibody Test

Rhea-AI Summary

Luminex Corporation (NASDAQ: LMNX) announced an Emergency Use Authorization (EUA) from the FDA for its xMAP® SARS-CoV-2 Multi-Antigen IgG Assay, enabling clinical labs to detect COVID-19 antibodies. This assay can process up to 96 samples in under three hours, demonstrating 100% specificity and over 96% sensitivity. Luminex's xMAP platforms, with more than 17,000 units sold, enhance testing accuracy while reducing labor needs. The assay is part of Luminex's ongoing efforts to address the pandemic and expands its portfolio of COVID-19 testing solutions.

Positive

• FDA EUA received for xMAP SARS-CoV-2 Multi-Antigen IgG Assay.
• Assay shows 100% specificity and over 96% sensitivity.
• Can process up to 96 samples in under three hours.
• Enhances accuracy and reduces labor needs compared to traditional ELISA assays.
• Part of a broader strategy with multiple COVID-19 tests receiving EUA.

Negative

• None.

AUSTIN, Texas, July 20, 2020 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the company's xMAP^® SARS-CoV-2 Multi-Antigen IgG Assay. Clinical laboratories can now use this serology assay to identify the presence of antibodies in people who have been infected with the virus that causes COVID-19. The test can be run on any of Luminex's xMAP-based high-throughput, gold-standard multiplex platforms, providing a more comprehensive and reliable assessment of immune response compared to conventional serology testing methods.

Designed to simultaneously detect antibodies against three antigens, the xMAP SARS-CoV-2 Multi-Antigen IgG Assay delivers high-quality results for up to 96 patient samples in under three hours. The assay detects antibodies of the immunoglobulin class G (IgG), which are an important component of an adaptive immune response and typically reflect sustained immunity to a given pathogen. 

The xMAP SARS-CoV-2 Multi-Antigen IgG Assay demonstrated specificity of 100 percent in human serum and greater than 99 percent in human plasma, with sensitivity greater than 96 percent for both human serum and plasma (>14 days post-symptom onset) in clinical studies. The assay uses the advanced multiplexing capabilities of xMAP instrumentation to reduce the risk of false positives and false negatives, giving laboratories increased confidence in the reliability of their test results. 

"More than 17,000 xMAP systems have been sold to laboratories around the world, and this FDA authorization creates important new opportunities for these labs to rapidly expand their COVID-19 testing capabilities with a highly accurate serology-based assay," said Nachum "Homi" Shamir, President and CEO of Luminex. "In close collaboration with our extensive network of partners and customers, Luminex continues to be on the frontlines in the mission-critical effort to address the current pandemic with state-of-the-art testing and innovative technologies such as xMAP." 

The new multi-antigen IgG assay can be run on all xMAP platforms, including MAGPIX^®, the Luminex^® 200, and FLEXMAP 3D^®. The assay reduces time to results, minimizes the volume of sample needed, and accelerates the testing process without the need for excess labor, representing advancements over commonly used ELISA-based antibody assays.

The xMAP-based serology test is the third COVID-19 Luminex test to receive an EUA, joining the NxTAG^® CoV Extended Panel and the ARIES^® SARS-CoV-2 Assay, which are rapid, RNA-based SARS-CoV-2 diagnostic tests that received EUAs in March and April of this year, respectively.

The SARS-CoV-2 Multi-Antigen IgG Assay is the first of several serology tests that Luminex is developing and plans to take to market through an EUA to help during the COVID-19 crisis. Additionally, the company continues to support numerous customers and partners developing innovative xMAP-based serology assays to facilitate vaccine and therapeutic development, perform epidemiologic studies, and better understand the extent and duration of protective immunity. 

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.

About xMAP^® Technology
A well-established platform for multiplex analysis with more than 50,000 peer-reviewed publications, 65+ Luminex global partners offering 1,300+ kits and custom assay solutions, xMAP Technology uses a bead-based multiplexing assay approach that can rapidly detect and quantify multiple analytes in a single sample. More information about xMAP Technology is available at -1%26h%3D984762712%26u%3Dhttps%253A%252F%252Fwww.luminexcorp.com%252Fxmap-technology%252F%26a%3Dhttps%253A%252F%252Fwww.luminexcorp.com%252Fxmap-technology%252F&a=https%3A%2F%2Fwww.luminexcorp.com%2Fxmap-technology%2F" rel="nofollow">https://www.luminexcorp.com/xmap-technology/. Additional information about xMAP's applications in serology-based testing can be found at https://www.luminexcorp.com/serology-based-testing.

About Luminex Corporation
At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health. We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at https://www.luminexcorp.com/.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements relating to Luminex's business outlook for the third quarter, as well as other statements that refer to future plans and expectations, particularly around the development of products to address the novel coronavirus. Such statements involve a number of risks and uncertainties. Words such as "can," "plans," "accelerate," "creates," "providing," "delivers," "reduces," "minimizes," "continues," "develop" and variations of such words and similar expressions are intended to identify forward-looking statements. Statements that refer to or are based on estimates, forecasts, projections, uncertain events or assumptions, and anticipated trends in our businesses or the markets relevant to them, also identify forward-looking statements. Such statements are based on management's expectations as of the date they were first made and, except as required by law, Luminex disclaims any obligation to update these statements to reflect future events or circumstances. Forward-looking statements involve many risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from the company's expectations include changes in market conditions, supply constraints and other disruptions, changes in capital requirements, and other factors set forth in Luminex's most recent Annual Report on Form 10-K filed with the SEC and available at Luminex's website at www.luminexcorp.com and the SEC's website at sec.gov.

Investor Contacts:
Harriss Currie
Sr. Vice President of Finance and CFO
hcurrie@luminexcorp.com 
512-219-8020

Media Contact:
Michele Parisi
Bioscribe
mparisi@bioscribe.com
925-864-5028

 

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SOURCE Luminex Corporation

FAQ

What is the significance of the FDA EUA for LMNX's xMAP SARS-CoV-2 Multi-Antigen IgG Assay?

The FDA EUA allows clinical laboratories to use this assay for identifying COVID-19 antibodies, providing a reliable testing option.

How effective is the xMAP SARS-CoV-2 Multi-Antigen IgG Assay?

The assay has shown 100% specificity and greater than 96% sensitivity for detecting antibodies.

How many samples can the xMAP assay process at once?

The assay can process up to 96 patient samples in under three hours.

What platforms can the xMAP SARS-CoV-2 Multi-Antigen IgG Assay be run on?

It can be utilized on all xMAP platforms, including MAGPIX®, Luminex® 200, and FLEXMAP 3D®.

Is the xMAP assay part of a larger suite of COVID-19 testing solutions by LMNX?

Yes, it is the third COVID-19 test from Luminex to receive EUA, expanding their testing solutions portfolio.