FDA-Approved Diagnostic Application Based on Luminex xMAP® System

Jan 15, 2025 FDA-Approved Diagnostic Application Based on Luminex xMAP® System

Innovative Luminex Technology

Luminex Corporation is a leading biotechnology company that develops, manufactures, and markets proprietary biological testing technologies used in life science research and clinical diagnostics. Widely known for its Multi-Analyte Profiling (xMAP®) Technology. Luminex provides fast and reliable results to support research in healthcare, life sciences, public health, and academic settings. Multiplexing is a high-throughput immunoassay approach that can test up to 500 targets in a single experiment, reducing sample, time, and reagent compared to traditional single plex assays. The “X” in xMAP® Technology represents the biomarkers being tested such as proteins, nucleic acids, or polysaccharides.

How does it work?

The xMAP® Technology uses analyzers based on the principles of fluorescent flow cytometry and labeled microspheres (beads) to capture multiple analytes in a single sample. The beads first pass through a red laser, which illuminates the internal dyes to distinguish the microsphere set. Following, a green laser activates the fluorescent reporter dye which determines the result of the assay.

Benefits of the xMAP® Technology

The xMAP® Technology is a high throughput testing and analysis platform able to detect up to 500 analytes in a single run. Each microsphere acts as an individual test, allowing researchers to conduct a wide range of protein- and nucleic acid-based multiple assays. The system is versatile, supporting several methods and chemistries, including nucleic acid hybridization, antigen-antibody binding, enzyme activity, receptor-ligand binding, and other protein interactions.

xTAG® Respiratory Viral Panel (RVP)

The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid test that uses multiplex PCR to detect multiple respiratory viruses from a nasopharyngeal swab sample, providing actionable results to guide treatment decisions. In January 2008, Luminex Corporation released xTAG® RVP as the first FDA-approved test for infectious respiratory disease viruses. This multiplex PCR-based test can identify up to 12 respiratory viruses from a single sample,

including Influenza A (H1, H3), Influenza B, human metapneumovirus, RSV (A, B), Parainfluenza (1,2,3), Rhinovirus, and Adenovirus.

NxTAG® Respiratory Pathogen Panel (RPP)

In 2015, the NxTAG® Respiratory Pathogen Panel (RPP) received FDA 510(k) clearance. The NxTAG® RPP is a molecular diagnostic test that can detect a wide range of viral and bacterial pathogens associated with respiratory infections. This panel screens 20 targets from nasopharyngeal specimens, including 17 viral pathogens and 3 bacterial pathogens. The viral pathogens detected are RSV A & B, Influenza A (including H1 & H3 variants), Influenza B, Parainfluenza (types 1–4), Human Metapneumovirus (hMPV), Adenovirus, Rhinovirus/Enterovirus, Coronavirus (HKU1, NL63, 229E, OC43), and Human Bocavirus. The bacterial pathogens include Chlamydophila pneumoniae and Mycoplasma pneumoniae. https://pmc.ncbi.nlm.nih.gov/articles/PMC7103694/

NxTAG® RPP v2 and SARS-CoV-2®

In March of 2021, Luminex Corporation received temporary Emergency Use Authorization (EUA) from the FDA for the expanded NxTAG® RPP + SARS-CoV-2® test. This high-throughput, multiplex test helps differentiate between common respiratory pathogens, including COVID-19 and Influenza, which have overlapping symptoms. It provides results to guide appropriate treatment by detecting up to 96 samples at once, identifying 19 viral and 2 bacterial pathogens in approximately 4 hours with minimal hands-on time. The assay runs on the MAGPIX® system. https://www.prnewswire.com/news-releases/luminex-receives-fda-emergency-use-authorization-and-ce-mark-for-expanded-nxtag-respiratory-panel-test-including-sars-cov-2-301240142.html

NxTAG® Respiratory Pathogen Panel v2

In May of 2024, Luminex's NxTAG® Respiratory Pathogen Panel (RPP) v2 received 510(k) clearance from the FDA for detecting respiratory infections. Designed for clinical and diagnostic laboratories, this test utilizes Luminex's molecular diagnostic technology to detect 19 viral pathogens, including SARS-CoV-2, from a single sample with just one pipetting step. The pathogen panel includes adenovirus, coronavirus, human metapneumovirus, Influenza A, Influenza B, Parainfluenza, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, and Rhinovirus/Enterovirus. Compatible with the MAGPIX® System, the NxTAG® RPP v2 provides high-quality, reliable result. https://us.diasorin.com/sites/default/files/press-releases/PR%20NxTAG%20RPP%20v2%20US-IVD_ENG.pdf

SBH Sciences and Multi-Analyte Profiling Capability

SBH Sciences has deep expertise in bioanalytical and drug discovery services, specializing in large molecules such as cytokines, enzymes, and antibodies. With over 500 customizable cell lines in-house, SBH offers custom in-vitro experimentation. Our wet lab features 11 advanced biomarker platforms, including the Luminex 200, which uses xMAP® Technology to enable high-throughput, multiplex assays for comprehensive analysis across a broad range of therapeutic areas. We are routinely testing 8 – 24 analytes panels covering the analysis of serum, plasma and cell culture supernates. Example of testing panels are: Human Immuno-Oncology, Cytokine, Chemokine, Growth Factor, Apoptosis Assays, and Inflammation Assays.

SBH is a dedicated Contract Research Organization focused on development and delivering accurate, reliable, and streamlined bioanalytical services to support confident research decisions. SBH already assisted over 350 biotechnology and diagnostics companies. Please contact us if you are interested in pre-clinical or clinical biomarker analysis. We would be pleased to collaborate with you.