Luminex Corporation issued the following announcement on June 29.
- Assay uses multiplexing for highly specific and sensitive detection of IgG antibodies against SARS-CoV-2
- Assay runs on all xMAP® platforms, the gold standard for multiplex serological testing, and detects previous infection and potential immunity to SARS-CoV-2
- Company plans to launch Research Use Only (RUO) version of assay later this month
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.
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