Luminex Corporation (Luminex) develops, manufactures, and sells proprietary biological testing technologies and products with applications throughout the life sciences industries, including diagnostics, pharmaceutical and research.
The company has established a position in several segments of the life sciences industries by developing and delivering products that satisfy a variety of customer needs in specific market segments, including multiplexing, accuracy, precision, sensitivity, specificit...
Luminex Corporation (Luminex) develops, manufactures, and sells proprietary biological testing technologies and products with applications throughout the life sciences industries, including diagnostics, pharmaceutical and research.
The company has established a position in several segments of the life sciences industries by developing and delivering products that satisfy a variety of customer needs in specific market segments, including multiplexing, accuracy, precision, sensitivity, specificity, reduction of labor and ability to test for proteins and nucleic acids. These needs are addressed by the company’s proprietary technologies.
Products
xMAP Products
The company’s xMAP products are based on an open architecture, multiplexing technology that combines existing biological testing techniques with illumination, advanced digital signal processing, detection and proprietary software. This technology is multi-analyte and multi-format, flexible and scalable and able to analyze both proteins and nucleic acids on a single platform. These products can simultaneously perform up to 500 tests in a single well, permitting up to 96,000 tests to be detected in approximately one hour. The company has a range of instruments built on this technology, leveraging proprietary optics, digital signal processors and software to automate data acquisition and analysis in real-time. Its products based on this technology are used within various segments of the life sciences industries, including the fields of drug discovery and development, and for clinical diagnostics, the novel coronavirus 2019 virus (COVID-19) virus testing, bio-defense, food safety and biomedical research.
xMAP Instruments
Luminex 100/200: Luminex 100/200 Systems are compact analyzers that integrate fluidics, optics and digital signal processing to measure up to 100 analytes simultaneously in a single tube or well of a microtiter plate using a small amount of sample. By combining lasers with digital signal processors and microcontrollers, these systems perform rapid, multi-analyte profiles under the control of a Windows-based personal computer and its proprietary software.
MAGPIX: The MAGPIX System is a multiplexing analyzer capable of performing qualitative and quantitative analyses of proteins and nucleic acids in a variety of sample matrices. This system can measure up to 50 analytes in a single reaction volume. The MAGPIX System is based on a detection mechanism that uses LEDs and a charge-coupled device imaging system, rather than the lasers and detection mechanisms used in the company’s FLEXMAP 3D and Luminex 100/200 instruments.
FLEXMAP 3D: The FLEXMAP 3D System is intended for use as a general laboratory instrument in the life sciences, diagnostics, and associated markets. This device can simultaneously measure up to 500 analytes from a single sample. Like the company’s Luminex 100/200 Systems, the FLEXMAP 3D System combines lasers with digital signal processors and microcontrollers, and these systems perform multi-analyte profiles under the control of a Windows-based personal computer and its proprietary software.
xMAP Consumables
MicroPlex Microspheres: The company’s Luminex 100/200, FLEXMAP 3D and MAGPIX Systems use polystyrene microspheres that are approximately 5.6 microns in diameter. It dyes the microspheres in sets with varying intensities of a red and a near infrared dye to achieve up to 100 distinct color sets. Each microsphere can be coupled with proteins, nucleic acids or other molecules to enable biological assays.
MagPlex Microspheres: The company’s MagPlex microspheres feature super-paramagnetic properties that make them ideal for running automated xMAP-based assays. It dyes the microspheres in sets with varying intensities of a red and a near infrared dye to achieve up to 500 distinct color sets. These microspheres can be moved or held in place by a magnetic field. Many automated systems utilize magnetic properties to automate the performance of the assay.
xTAG Microspheres: The company’s xTAG microspheres are dyed microspheres that are linked to a set of 100 proprietary nucleic acid capture sequences providing a ‘universal array’ for DNA and RNA work. They are designed for conducting genotyping and other nucleic acid-based experiments in the life sciences, pharmaceutical and clinical diagnostic markets. When used in conjunction with its Luminex systems, xTAG microspheres are designed to simplify the molecular assay development process and increase assay flexibility. xTAG microspheres may be used by customers to develop LDT assays and are used in the company’s xTAG assay kits.
SeroMAP Microspheres: The company’s SeroMAP microspheres represent 100 distinct sets of microspheres that are designed for specific protein-based serological applications. Certain partners use this product for enhanced sensitivity in serum-based assays.
Calibration and Control Microspheres: Calibration microspheres are microspheres of known fluorescent light intensities used to calibrate the settings for the classification and reporter channel for the Luminex systems. Control microspheres are microspheres that are used to verify the calibration and optical integrity for both the classification and reporter channels for the various systems.
xMAP Software
xPONENT: The company’s xPONENT Software is included in all of its xMAP instruments and is designed to enhance both ease-of-use and automation capabilities, expanding xMAP functionality in its core markets. The software suite incorporates important features, all designed to simplify laboratory workflow and increase productivity, including enhanced security (21 CFR (Code of Federal Regulations) Part 11 compliance and electronic signatures), integration capabilities that allow customers to transmit and receive data from Laboratory Information Systems (LIS/LIMS), integration with the automated sample preparation systems, the ability to run magnetic bead applications and touchscreen capability. xPONENT is sold on new Luminex 100/200, FLEXMAP 3D, and MAGPIX Systems; and is available as an upgrade to existing Luminex systems in the marketplace.
TDAS: The company’s TDAS Software is an analysis program designed to complement its xTAG Technology, which uses a proprietary universal tag system that allows for the development and optimization of nucleic acid assays. TDAS Software simplifies workflow and increases productivity by helping to identify pathogens associated with infectious diseases and genetic mutations. TDAS Software produces non-subjective results, which can be viewed in the software, integrated with LIS, and exported or printed into reports.
xTAG Assays and Product Family
The company’s xTAG family of products includes infectious disease panels and genetic testing panels that utilize Luminex xMAP bead-based detection platforms in combination with proprietary molecular chemistries. xTAG infectious disease in vitro diagnostic (IVD) products enable its laboratory end users to identify the causative agent for respiratory and gastrointestinal infections, which are major causes of illness and mortality globally. xTAG Assays for genetic testing include several IVD kits for cystic fibrosis genotyping and a number of pharmacogenetic assays that may be used to profile genetic mutations related to drug metabolism. NxTAG chemistry, a streamlined version of the xTAG chemistry, which includes assays for both respiratory and gastrointestinal infections. This product family includes the company’s the U.S. Food and Drug Administration (FDA)-cleared and CE-marked NxTAG CoV Extended Panel, NxTAG Respiratory Pathogen Panel, xMAP SARS-CoV-2 Multi-Antigen IgG Assay, xTAG CYP2C19 Kit v3, xTAG CYP2D6 Kit v3, xTAG Cystic Fibrosis (CFTR) 39 Kit v2, xTAG Cystic Fibrosis (CFTR) 60 Kit v2, xTAG Cystic Fibrosis (CFTR) 71 Kit v2, xTAG Gastrointestinal Pathogen Panel, xTAG Respiratory Viral Panel (RVP), and xTAG RVP FAST v2.
ARIES Products
The ARIES System, available in single-module or double-module configurations, is the company’s sample-to-answer real-time polymerase chain reaction platform for its MultiCode-RTx technology, including IVD assays. The ARIES System is used with specific assays to measure multiple analytes indicative of infectious disease. The ARIES System uses internal barcode scanning and other advanced features to minimize operator errors. Each independent module supports from one to six cassettes, allowing both short turn around testing and batch testing. The ARIES System can run IVD, MultiCode Analyte Specific Reagents, and LDTs using the ARIES Exo+ Ready Mix and extraction cassettes with a common Universal Assay Protocol.
SYNCT: The company’s SYNCT data management software solution can compile data from multiple ARIES Systems or multiple MAGPIX Systems (NxTAG-enabled), assisting laboratories to leverage their data to decrease laboratory costs and improve patient care. In addition, SYNCT Standard Curve Analysis Software enables labs to create quantitative LDTs.
ARIES Assays and Product Family
ARIES Cassettes: ARIES Cassettes are self-contained assay consumables designed to run an automated, sample-to-answer molecular assay on the ARIES System. The cassettes make use of proprietary injection-molded parts, as well as MultiCode and other reagents, to perform automated extraction, purification, elution, amplification and analysis of nucleic acid testing from a variety of different sample types.
The company’s ARIES product family includes its FDA-cleared and CE-marked ARIES HSV 1&2 Assay, ARIES Flu A/B & RSV Assay, ARIES Group B Streptococcus Assay, ARIES Group A Strep Assay, ARIES Bordetella Assay, ARIES Norovirus Assay, ARIES C. difficile Assay, and ARIES MRSA Assay in 2019. In addition, the company launched an Emergency Use Authorization-cleared the novel coronavirus (SARS-CoV-2) Assay in 2020.
VERIGENE Products
The VERIGENE System is a semi-automated, multiplex, molecular analysis system for the clinical diagnostics market that detects infectious pathogens and drug resistance markers. The VERIGENE System consists of VERIGENE Test Cartridges, which are single-use, self-contained test units; and VERIGENE instruments, including the VERIGENE Processor SP, which is a modular benchtop analyzer that combines automated nucleic acid extraction, purification, amplification (if needed), and hybridization in each module, as well as the VERIGENE Reader, which manages sample information and reads results from processed cartridges. Tests that run on the VERIGENE System are primarily designed to identify infections in the bloodstream, respiratory tract, and gastrointestinal tract.
VERIGENE Assays and Product Family
VERIGENE Cartridges: VERIGENE test cartridges are single-use, self-contained test units consist of a reagent pack, which is a microfluidic cassette that contains all of the hybridization reagents needed for a single test that also captures the waste materials generated during test processing; and a substrate holder, which contains a glass slide that serves as a solid support for the microarray used to capture targeted nucleic acids. Each test cartridge is designed for multiplex analyses of one patient sample.
The company’s VERIGENE product family includes its FDA-cleared and CE-marked VERIGENE Bloodstream Infection tests, VERIGENE Gastrointestinal Infection tests, including the VERIGENE C. difficile Test and the VERIGENE Enteric Pathogens Test, and the VERIGENE Respiratory Pathogens Flex Test, as well as other VERIGENE next generation assays in development.
Amnis/Guava Products
The company’s Amnis and Guava products provide technology that powers flow-based detection systems. Amnis Systems are a family of imaging flow cytometry products for cell-based analysis. FlowSight and ImageStream imaging flow cytometers combine the speed and sensitivity of flow cytometry with the functional detail and spatial information of microscopy. The Guava portfolio of products, which are versatile, easy-to-use cytometry systems based on microcapillary fluidics technology, which include the Muse Cell Analyzer, a compact and affordable system for absolute cell counting, viability, and basic cell health analyses; and the Guava easyCyte System, a versatile benchtop platform for additional, multi-dimensional cell health and biological assessments.
Amnis FlowSight Imaging Flow Cytometer: The FlowSight imaging flow cytometer provides high-sensitivity flow cytometry and imagery with up to twelve 20X multi-color images of every cell, including side scatter and brightfield, at up to 5,000 events per second. It is upgradeable to 4 lasers, offers automated sample loading for walk-away operations and is supported with image analysis software with fluorescence compensation and analysis wizards.
Amnis ImageStream Mark II Imaging Flow Cytometer: The ImageStream System is a multispectral imaging flow cytometer designed for the acquisition of up to 12 channels of cellular imagery at up to 60X magnification. By collecting large numbers of digital images per sample and providing a numerical representation of image-based features, the ImageStream System combines the per cell information content provided by standard microscopy with the statistical significance afforded by large sample sizes common to standard flow cytometry.
Amnis CellStream: The CellStream Flow Cytometer delivers high sensitivity and flexibility for cell and particle analysis. This compact system may be configured with up to seven lasers to adapt to a range of analytical requirements. With highly sensitive and configurable optics, researchers benefit from multiparameter detection capabilities, while maintaining the flexibility to tailor and expand the system according to their research needs and budget.
Guava easyCyte Benchtop Flow Cytometer: The Guava easyCyte line includes compact benchtop flow cytometer models that offer up to 3 lasers and 14 parameters with sensitivity and optional high throughput auto-sampling capabilities. Guava easyCyte Systems use patented, microcapillary, laser-based technology capable of detecting mammalian and microbial cells, particles and beads. The instruments are supported by a line of 13 reagent FlowCellect Kits and elegant InCyte acquisition and analysis software.
Muse Cell Analyzer: The Muse Cell Analyzer is a device that uses patented miniaturized fluorescent detection and microcapillary technology to deliver cell analysis. It is versatile enough to analyze both suspension and adherent cells 2–60 µm in diameter and includes a touchscreen interface, intuitive software and optimized ‘Mix-and-Read’ assays.
IDEAS: The company’s IDEAS image analysis software for its Amnis Flow Cytometers provides detailed analysis of intensity, location and co-location of probes. IDEAS offers tools for statistically robust analysis of images, as well as standard flow cytometry graphing tools and statistics for hundreds of morphological features in addition to intensity.
Customers
In 2020, top five customers accounted for 22% of the company’s total revenues. The company’s customers include clinical diagnostic, pharmaceutical, biotechnological, and research institutions, as well as chemical and industrial companies.
International Operations
The company ships products to a number of customers outside the United States (U.S.), primarily including customers in Canada, Europe and the Asia-Pacific region. The company has foreign subsidiaries in Canada, the Netherlands, the United Kingdom, Germany, France, the People’s Republic of China (P.R. China), Japan, and Hong Kong.
Customer Operations
The company’s Customer Operations Group provides technical support, field service and assistance to its customers, its distributors, its strategic partners and their customers.
Remote Support: The company’s Technical Support department assists users primarily through a toll-free hotline, internet interface and e-mail communications.
Training: The company offers comprehensive programs in basic system training, advanced assay development, instrument field service and technical support functions. A portion of its training material is web-based and available online.
Field Support: The company has field service and field application personnel based across North America, Europe, China and Japan. In addition, several of its distributors and strategic partners provide their own field service and field application support.
Research and Development
The company’s research and development expense was $53.7 million for the year ended December 31, 2020.
The company’s research and development projects include:
New Platform and Technology Development: The company is working on the development of the next generation, sample-to-answer, molecular diagnostic, automated VERIGENE II platform. This involves the final design and development of the instrument, consumables and software, as well as the development of a menu of assays for this system. The company expects to commercially launch the VERIGENE II System in 2021.
New Sample-to-Answer Menu Development: The company has a pipeline of new syndromic assays for use on the next generation VERIGENE II platform. These automated assays are primarily in the area of infectious disease testing.
xMAP INTELLIFLEX System: The company’s xMAP system is nearing testing with partners and it will be ready for commercial launch in the first half of 2021.
Strategy
The key elements of the company’s strategy include expanding usage of its automated molecular infectious disease testing solutions; enabling and expanding end markets for its xMAP technologies through its partnership arrangements; developing and expanding the image-based flow cytometry market; developing and delivering market-leading molecular diagnostic platforms and assays; actively pursuing acquisitions to accelerate its business strategies; and continuing to develop the partnership channel focused on select key markets.
Intellectual Property
The company owns 821 issued patents worldwide directed to various aspects and applications of its products and technology, including 237 issued patents in the United States. Other countries in which the company has issued patents directed to various aspects and applications of its products and technology include France, Germany, the United Kingdom, Australia, Japan, the Netherlands, Canada, Hong Kong, China and South Korea. The company’s patent portfolio also includes 110 pending patent applications in the United States and other foreign jurisdictions. It also holds patents covering the fluorescently dyed, magnetically responsive microspheres. In addition, multiple granted patents and pending applications describe aspects of MultiCode technology, xTAG technology, nanoparticle technology, the ARIES and VERIGENE Systems, NxTAG technology, imaging flow cytometry technology and capillary flow cytometry technology.
Trademarks: Amnis, ARIES, CellStream, easyCheck, easyCyte, Flex, FLEXMAP 3D, FlowCellect, FlowSight, Guava, GuavaSoft, Guava Express, Guava Nexin, IDEAS, ImageStream, InCyte, INSPIRE, LumAvidin, Luminex, Luminex 100, Luminex 200, SD, MAGPIX, MagPlex, MagPlex-TAG, MicroPlex, MultiCode, Muse, NxTAG, SeroMAP, SpeedBead, SYNCT, VERIGENE, ViaCount, xMAP, xMAP INTELLIFLEX, xPONENT, xTAG, and XYP are trademarks of the company or one of its subsidiaries.
Regulation
The company’s products are generally considered medical devices and are subject to regulation by numerous government agencies, including the FDA and similar agencies outside the United States.
Laboratories that purchase certain of the company’s products are subject to regulation under the Clinical Laboratory Improvement Amendments of 1988, which applies to all clinical laboratory testing performed on humans in the United States (with the exception of clinical trials and basic research).
The company produces CE marked products, which are subject to a number of different European Union Directives, including but not limited to, the In Vitro Diagnostic Medical Devices Directive 98/79/EC.
The State Food and Drug Administration, P.R. China issues certificates that are required for registration and approval to import the company’s products into China.
The company’s operations in the United States are subject to various federal and state fraud and abuse laws, including without limitation, the federal Anti-Kickback Statute, the Eliminating Kickbacks in Recovery Act of 2018, and state and federal marketing compliance laws.
Competition
The company’s diagnostic market competitors include Abbott Laboratories; Life Technologies Corporation (a Thermo Fisher Scientific Inc. brand); BioFire Diagnostics, LLC (a bioMerieux S.A. company); Cepheid (a Danaher Corporation company); GenMark Dx; Roche Diagnostics; Siemens Medical Solutions; Hologic, Inc.; Alere (part of Abbott Laboratories); Quidel Corporation; Focus Diagnostics (DiaSorin S.p.A); T2 Biosystems, Inc.; Accelerate Diagnostics, Inc.; Meridian Bioscience, Inc.; and Illumina, Inc.
History
Luminex Corporation was founded in 1995. The company was incorporated under the laws of the state of Texas in 1995. It was reincorporated in the state of Delaware in 2000.
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