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DIASORIN MOLECULAR

DIASORIN MOLECULAR

DiaSorin Molecular LLC manufactures and distributes innovative molecular diagnostic products on the versatile LIAISON® MDX platform. We are a vendor partner to Hospital and Reference Laboratories that provides value through sales, service and support solutions.
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Covid-19 DIASORIN MOLECULAR

Clinical Laboratory

Respiratory Infections Test
LIAISON PLEX® Respiratory Flex Assay

LIAISON PLEX® Respiratory Flex Assay is a sample-to-answer, multiplexed in vitro diagnostic test for the detection and identification of respiratory disease-causing viruses and bacteria from patient samples, all in one self-contained cartridge. To be used on the LIAISON PLEX® System, this multiplexed qualitative molecular test enables the simultaneous detection and identification of up to 19 bacterial and viral targets, including SARS-CoV-2.
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COVID-19 Test Kit
Simplexa COVID-19 Direct Kit

The Simplexa COVID-19 Direct kit allows for fast results directly from BAL, nasal swab, nasal wash/aspirate, nasopharyngeal swab and saliva specimens, eliminating traditional RNA extraction steps. The assay has demonstrated excellent clinical agreement and turnaround time, allowing for optimal allocation of critical resources and effective patient management decision making.
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About DIASORIN MOLECULAR

Number of Employees: 100-499
Year of Establishment: 1978
DiaSorin Molecular LLC manufactures and distributes innovative molecular diagnostic products on the versatile LIAISON® MDX platform. We are a vendor partner to Hospital and Reference Laboratories that provides value through sales, service and support solutions.

Recently updated

Multiplexing System
MAGPIX® System

The MAGPIX® System is a cost-effective, streamlined imaging-based analyzer that simultaneously measures up to 50 analytes in a single microplate well. This compact, imaging-based instrument is designed to analyze multiplex assays performed using Luminex proprietary xMAP® Technology.
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Respiratory Infections Test
NxTAG® Respiratory Pathogen Panel

The NxTAG® Respiratory Pathogen Panel is a multiplexed in vitro diagnostic test for the detection and identification of respiratory disease-causing viruses and bacteria. It detects 20 respiratory pathogens in a single well, enabling thorough respiratory health analysis, and produces results for 24 extracted DNA samples in less than three hours with only a single pipetting step.
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Gastrointestinal Pathogen Test
xTAG® Gastrointestinal Pathogen Panel (GPP)

The xTAG® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis. This highly scalable gastrointestinal test offers customizable detection of bacterial, viral, and parasitic pathogens to rule out the causes of infectious diarrhea.
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Clinical Laboratory

Multiplexing System
MAGPIX® System

The MAGPIX® System is a cost-effective, streamlined imaging-based analyzer that simultaneously measures up to 50 analytes in a single microplate well. This compact, imaging-based instrument is designed to analyze multiplex assays performed using Luminex proprietary xMAP® Technology.
More details

Respiratory Infections Test
NxTAG® Respiratory Pathogen Panel

The NxTAG® Respiratory Pathogen Panel is a multiplexed in vitro diagnostic test for the detection and identification of respiratory disease-causing viruses and bacteria. It detects 20 respiratory pathogens in a single well, enabling thorough respiratory health analysis, and produces results for 24 extracted DNA samples in less than three hours with only a single pipetting step.
More details

Gastrointestinal Pathogen Test
xTAG® Gastrointestinal Pathogen Panel (GPP)

The xTAG® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis. This highly scalable gastrointestinal test offers customizable detection of bacterial, viral, and parasitic pathogens to rule out the causes of infectious diarrhea.
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C. difficile Test
VERIGENE® Clostridium difficile Test

The VERIGENE® Clostridium difficile Test is a multiplexed, qualitative test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic C. difficile and for the presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens. The test provides a rapid, easy-to-use, and cost-effective solution for the identification of toxin-producing C. difficile, empowering clinicians to rapidly and accurately diagnose C. difficile to ensure appropriate treatment.
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Gram-Negative Blood Culture Test
VERIGENE® BC-GN

The VERIGENE® BC-GN is a Gram-Negative Blood Culture Test for the detection and identification of pathogenic gram-negative bacteria. This multiplexed in vitro diagnostic test with a non-amplified molecular chemistry assay design helps minimize false results while allowing for universal collection media.
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Molecular Diagnostic Platform
LIAISON PLEX® System

The LIAISON PLEX® System is a next-generation, multiplex, sample-to-answer molecular diagnostic platform. Its proprietary Flex® Software enables users to pay only for required targets, with the option to customize targets as needed. The LIAISON PLEX® System runs panels that are fully integrated to perform amplification, hybridization, and detection of nucleic acids in just one cartridge.
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Blood Culture Test
LIAISON PLEX® Yeast Blood Culture (BCY)

The LIAISON PLEX® Yeast Blood Culture Assay represents the first of three multiplex blood culture panels for the microbiological diagnosis of bloodstream infections on the new multiplexing platform of the Group. It is the second molecular multiplexing panel on the LIAISON PLEX® system and detects 16 pathogens commonly associated with fungemia (fungal bloodstream infections).
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Respiratory Infections Test
LIAISON PLEX® Respiratory Flex Assay

LIAISON PLEX® Respiratory Flex Assay is a sample-to-answer, multiplexed in vitro diagnostic test for the detection and identification of respiratory disease-causing viruses and bacteria from patient samples, all in one self-contained cartridge. To be used on the LIAISON PLEX® System, this multiplexed qualitative molecular test enables the simultaneous detection and identification of up to 19 bacterial and viral targets, including SARS-CoV-2.
More details

Enteric Pathogens Test
VERIGENE Enteric Pathogens Test

The VERIGENE Enteric Pathogens Test is a multiplexed, qualitative test for the simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium. This rapid, easy-to-use, and cost-effective alternative to traditional stool diagnostics delivers clinical, economic, and workflow benefits while empowering clinicians to rapidly optimize treatment for enteric pathogens.
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Pharmacogenetic Rapid Test
xTAG CYP2C19 Kit v3

xTAG CYP2C19 Kit v3 is a multiplexed nucleic acid test intended for the detection of 2C19 from EDTA and citrate blood. This highly scalable genetic test with clinically relevant mutations can help clinicians identify mutations indicative of adverse effects with certain drugs.
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Blood Culture Test
VERIGENE Gram-Positive Blood Culture Test

The VERIGENE Gram-Positive Blood Culture Test is a multiplexed in vitro diagnostic test for the detection and identification of pathogenic gram-positive bacteria. It allows for proven clinical impact, and outstanding, economic value coupled with the right assay design.
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GI Pathogen Panel
NxTAG Gastrointestinal Pathogen Panel

The NxTAG Gastrointestinal Pathogen Panel (GPP) is a highly scalable gastrointestinal test with customizable detection of bacterial, viral, and parasitic pathogens to rule out the causes of infectious diarrhea. This multiplexed nucleic acid test is intended for the simultaneous qualitative detection and identification of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis.
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Cystic Fibrosis Test
xTAG Cystic Fibrosis (CFTR)

xTAG Cystic Fibrosis (CFTR) is a multiplexed nucleic acid test intended for the detection of clinically relevant mutations by ACMG/ACOG. It empowers clinicians with the ability to test for the 23 CFTR mutations recommended by ACMG/ACOG and can simplify workflow with faster assay turnaround times.
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Group B Strep Test
Simplexa GBS Direct Kit

The Simplexa GBS Direct Kit is an in-vitro qualitative real-time PCR assay intended for detecting Group B Strep directly in Lim Broth enriched vaginal/rectal swab cultures. It has a simple workflow, enabling unextracted Lim broth enriched vaginal/rectal swabs and ready-to-use PCR reagent to be loaded on a re-usable Direct Amplification Disc on the LIAISON MDX system.
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C. difficile Test
Simplexa C. difficile Universal Direct Kit

The Simplexa C. difficile Universal Direct Kit is intended for simple and high-throughput C. difficile testing and allows users to perform up to 94 patient samples per run with results in about 1 hour. It offers a high-throughput and simplified workflow without DNA isolation while delivering diagnostic confidence with greater than 99% positive agreement.
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VZV Molecular Test
Simplexa VZV Swab Direct Kit

The Simplexa VZV Swab Direct Kit is a CLIA moderate complexity assay for the direct detection of the VZV DNA Polymerase gene from only 50 µl of cutaneous and mucocutaneous swab specimens. Designed for fast and accurate VZV molecular testing, the assay improves efficiency with a true sample-to-answer workflow without DNA extraction.
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Group A Strep Test
Simplexa Group A Strep Direct Kit

The Simplexa Group A Strep Direct Kit is a CLIA moderate complexity assay for fast, flexible, and accurate Group A Strep testing using throat swabs. It improves efficiency with a true sample-to-answer workflow without DNA extraction and provides results in about an hour.
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Cytomegalovirus (CMV) Test
Simplexa Congenital CMV Direct Kit

The Simplexa Congenital CMV Direct Kit is a real-time PCR assay for the in vitro qualitative detection of cytomegalovirus (CMV) from saliva swabs and urine specimens from infants less than 21 days of age. The assay provides broad coverage and has demonstrated high performance with excellent clinical agreement against a composite reference method consisting of PCR/bi-directional sequencing.
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Clostridium Difficile Test
Simplexa C. difficile Direct Kit

The Simplexa C. difficile Direct Kit is an essential component of Clostridium difficile infection testing and allows labs to improve efficiency with a true sample-to-answer workflow without DNA extraction. It reduces result delays and costly repeat testing with ease of use and a low invalid rate, and provides results in about an hour.
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Epstein-Barr Virus Real-Time PCR Assay
Simplexa EBV Kit

The Simplexa EBV Kit is a real-time PCR assay intended for the in vitro quantitative detection of Epstein-Barr virus (EBV). It is a reliable and accurate assay for quantitation EBV nucleic acids in whole blood specimens and is meant to be used on the LIAISON MDX system which is capable of running 94 patient samples at the same time.
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Influenza A/B Test
Simplexa Flu A/B & RSV Kit

The Simplexa Flu A/B & RSV Kit is intended for the reliable detection and differentiation of influenza A virus, influenza B virus and RSV. It has 100% sensitivity and greater than 98% specificity and is meant to be used on the LIAISON MDX system which is capable of running 94 patient samples at the same time.
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Dengue Real-Time RT-PCR Test
Simplexa Dengue Kit

The Simplexa Dengue Kit is a real-time RT-PCR assay for the in vitro detection and typing of dengue virus serotypes 1, 2, 3 and 4 from human serum.
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Cytomegalovirus Detection Test
Simplexa CMV Kit

The Simplexa CMV Kit is a real-time PCR assay intended for the in vitro quantitative detection of cytomegalovirus (CMV) nucleic acids in whole blood and plasma specimens. It has a sensitivity of 713 IU/mL and has been aligned to the World Health Organization (WHO) standard for CMV testing.
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Bordetella Pertussis/Parapertussis Test
Simplexa Bordetella Direct Kit

The Simplexa Bordetella Direct Kit is a CLIA moderate complexity assay for the direct detection and differentiation of Bordetella pertussis and Bordetella parapertussis. The assay improves efficiency with a true sample-to-answer workflow without DNA extraction and provides results in about an hour direct from nasopharyngeal swabs.
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Flu A/B & RSV Test
Simplexa Flu A/B & RSV Direct Gen II Kit

The Simplexa Flu A/B & RSV Direct Gen II Kit offers the latest generation assay with enhanced strain coverage, performance and testing flexibility to differentiate influenza A, influenza B and RSV. Intended for use on the LIASON MDX, the CLIA moderate complexity assay with the most comprehensive strain coverage (over 100 strains) ensures high performance and provides improved efficiency with a true sample-to-answer workflow without RNA extraction.
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COVID-19 Test Kit
Simplexa COVID-19 Direct Kit

The Simplexa COVID-19 Direct kit allows for fast results directly from BAL, nasal swab, nasal wash/aspirate, nasopharyngeal swab and saliva specimens, eliminating traditional RNA extraction steps. The assay has demonstrated excellent clinical agreement and turnaround time, allowing for optimal allocation of critical resources and effective patient management decision making.
More details

Direct Molecular Assay
Simplexa Group B Strep Direct Kit

The Simplexa Group B Strep Direct assay enables the direct in vitro detection of Group B Streptococcus. The assay is more specific than traditional testing methods and features a fast workflow.
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Diagnostic Assay
Simplexa VZV Direct

The Simplexa VZV Direct assay enables the direct detection of varicella-zoster virus DNA from CSF. The assay was designed for use on the LIAISON MDX instrument and intended for use with patients with suspected infections of the CNS.
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Thermocycler
LIAISON MDX

The LIAISON MDX is an innovative and powerful thermocycler with two consumable disc options: the 8-well Direct Amplification Disc for sample-to-answer testing and the 96-well Universal Disc for higher volume testing. Supported by an expanding menu of molecular assays, it is flexible enough to run real-time PCR for qualitative, quantitative and multi-analyte detection, and can perform both IVD as well as laboratory developed tests.
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Real-time Thermal Cycler
LIAISON IAM

The LIAISON IAM is a small and exceptionally robust instrument developed specifically to support the isothermal Q-LAMP technology for amplification of nucleic acids. It delivers rapid, comprehensive and highly reliable results to aid the molecular diagnosis of leukemia at disease onset, and improve laboratory workflow and decision-making on patient care.
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Serology Test Kits
DxSelect

DxSelect serology products aids in the discovery and surveillance of emerging infectious diseases such as C. pneumoniae, C. trachomatis, and C. psittaci, among others. Used by researchers and health agencies worldwide for more than three decades, it enables users to conduct testing in their own laboratories.
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Serology Test Kits
HerpeSelect

The HerpeSelect type specific serology tests aid in the presumptive diagnosis of HSV-1 and HSV-2 in sexually active adults or expectant mothers. Used by leading reference laboratories worldwide, it provides physicians with the information they need to confidently diagnose and counsel their patients on treatment and life style decisions.
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PCR Test
Simplexa HSV 1 & 2 Direct

The Simplexa HSV 1 & 2 Direct assay is designed for the direct detection and differentiation of HSV-1 and HSV-2 in cerebral spinal fluid. The test can provide results in about an hour, and is intended to positively impact patient management and survival statistics.
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