Luminex Submits Emergency Use Authorization Request to U.S. FDA for COVID-19 Antibody Test

Rhea-AI Summary

Luminex Corporation (NASDAQ: LMNX) has submitted an Emergency Use Authorization request to the FDA for its xMAP® SARS-CoV-2 Multi-Antigen IgG assay, aimed at enhancing antibody detection in COVID-19 patients. This assay processes up to 96 samples in under three hours and is compatible with all xMAP® platforms. The test detects IgG antibodies, indicating prior infection and potential immunity. Luminex plans to launch this test for Research Use Only later this month, expanding its COVID-19 testing portfolio that already includes two diagnostic tests.

Positive

• Received FDA Emergency Use Authorization request for the xMAP® SARS-CoV-2 Multi-Antigen IgG assay.
• Assay processes up to 96 samples in under three hours, enhancing testing capacity.
• Compatible with over 17,000 sold xMAP® platforms globally.
• Expands COVID-19 testing portfolio, positioning Luminex favorably in the healthcare market.

Negative

• None.

AUSTIN, Texas, June 29, 2020 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that the company has submitted an Emergency Use Authorization request to the U.S. Food and Drug Administration (FDA) for its xMAP^® SARS-CoV-2 Multi-Antigen IgG assay. The assay was developed to provide additional capacity to detect antibodies in patients who may have been exposed to or infected by SARS-CoV-2. It delivers excellent results for up to 96 samples in under three hours and is designed to be run on all xMAP^® platforms, with more than 17,000 systems sold globally, and 65+ Luminex global partners offering 1,300+ kits and custom assay solutions.

SARS-CoV-2 antibodies can be detected in both plasma and serum, usually within one to three weeks after infection. These antibodies help determine whether a person has previously been infected by SARS-CoV-2 and may have developed some level of immunity to the disease. The new serology test detects antibodies of the immunoglobulin class G (IgG), which are an important component of an adaptive immune response and typically reflect sustained immunity. The xMAP SARS-CoV-2 Multi-Antigen IgG assay uses multiplexing to simultaneously detect antibodies to three SARS-CoV-2 antigens and includes multiple internal controls to provide a more comprehensive and reliable assessment of the immune response compared to other serology assays.

"By expanding our COVID-19 testing offerings into serology testing with our first multi-antigen IgG assay, Luminex is taking another important step to support laboratories and research institutions that are working to meet the continued high demand for a range of testing solutions," said Nachum "Homi" Shamir, President and CEO of Luminex. "Serology testing is essential because it uniquely detects prior exposure to a pathogen, as well as possible immunity. Our xMAP technology is ideally suited for serology testing because of its proven ability to deliver extremely high specificity and sensitivity on a high-throughput, gold-standard multiplex platform."

The Luminex IgG serology test is the first in a series of such tests that Luminex plans to develop internally to address the breadth of testing and surveillance needs related to the COVID-19 pandemic. The company plans to launch the test for Research Use Only (RUO) later this month. Luminex previously launched two SARS-CoV-2 diagnostic tests for use by both high-complexity, high-throughput reference labs and moderate complexity, sample-to-answer testing locations, on the company's MAGPIX^® System and ARIES^® System, respectively.

"In addition to commercializing our own serology tests, Luminex will continue to support a number of highly reputable academic medical centers and research labs, as well as a growing number of partners, that are conducting research into innovative serological applications on the open xMAP^® platform. This research is facilitating vaccine and therapy development, enhancing pandemic surveillance by quantifying exposure rates in communities, and studying the dynamics of the immune response to better understand the extent and longevity of protective immunity," said Shamir.

More information about xMAP's applications in serology-based testing can be found at https://www.luminexcorp.com/?wpdmdl=42265.

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. Multiplex serological testing can simultaneously analyze large numbers of antigens for large-scale screening and has the potential to replace ELISA assays. Serological assays on the xMAP platform reduce time to results, minimize the volume of sample needed, and accelerate the testing process without the need for excess labor, demonstrating advancements over ELISA assays for antibody testing. More information about xMAP Technology is available at https://www.luminexcorp.com/xmap-technology/.

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 luminexcorp.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements relating to Luminex's business outlook, 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," "deliver", "plans," "will," "accelerate," "design" 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 latest news about Luminex Corporation's COVID-19 testing efforts?

Luminex has submitted an Emergency Use Authorization request to the FDA for its xMAP® SARS-CoV-2 Multi-Antigen IgG assay.

How does Luminex's new COVID-19 antibody test work?

The xMAP® assay detects IgG antibodies in plasma and serum, indicating prior infection and potential immunity.

What are the capabilities of Luminex's xMAP® SARS-CoV-2 Multi-Antigen IgG assay?

It can process up to 96 samples in under three hours and includes multiple internal controls for reliability.

When will Luminex launch its new antibody test?

Luminex plans to launch the xMAP® test for Research Use Only later this month.

How does Luminex's testing technology compare to traditional methods?

Luminex's xMAP® technology provides higher specificity and sensitivity and allows multiplex analysis in a single sample.