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Illumina

Illumina develops, manufactures and markets integrated systems for the analysis of genetic variations and biological functions. The company also provides sequencing and array-based solutions for genetic analysis, as well as genotyping, NIPT and whole-genome sequencing services for government laboratories, hospitals, an ...
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Covid-19 Illumina

Clinical Laboratory

SARS-CoV-2 NGS Test
Illumina COVIDSeq Test

The Illumina COVIDSeq Test is a high-throughput, next-generation sequencing test is intended for the detection of SARS-CoV-2 virus RNA in authorized countries and virus genome analysis for research use. This amplicon-based NGS test includes 2019-nCoV primers designed to detect RNA from the SARS-CoV-2 virus in nasopharyngeal, oropharyngeal, and mid-turbinate nasal swabs from patients with signs and symptoms of infection who are suspected of COVID-19.
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SARS-CoV-2 (COVID-19) Test
Illumina COVIDSeq Test

The Illumina COVIDSeq Test is the first NGS test approved for use under the US Food and Drug Administration’s Emergency Use Authorization (EUA). This amplicon-based NGS test includes 2019-nCoV primers designed to detect RNA from the SARS-CoV-2 virus in nasopharyngeal, oropharyngeal, and mid-turbinate nasal swabs from patients with signs and symptoms of infection who are suspected of COVID-19. The test can be run on the Illumina NovaSeq 6000 Sequencing System, NextSeq 500 Sequencing System, NextSeq 550 Sequencing System, or NextSeq 550Dx Instrument.
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News of Illumina

Illumina and Boehringer Ingelheim Partner to Develop Companion Diagnostics (CDx) for Cancer Treatment

20 Jan 2022
Illumina and Boehringer Ingelheim Partner to Develop Companion Diagnostics (CDx) for Cancer Treatment
Illumina Inc. (San Diego, CA, USA) has entered into a partnership with Boehringer Ingelheim (Ingelheim am Rhein, Germany; www.boehringer-ingelheim.com) to develop companion diagnostics (CDx) for several programs in the latter’s oncology pipeline. The partnership aims to accelerate the development of therapy selection and precision medicines for patients with advanced cancer.
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Illumina Acquires GRAIL to Accelerate Patient Access to Life-Saving Multi-Cancer Early-Detection Test

20 Aug 2021
Illumina Acquires GRAIL to Accelerate Patient Access to Life-Saving Multi-Cancer Early-Detection Test
Illumina, Inc. (San Diego, CA, USA) has acquired GRAIL (Menlo Park, CA, USA), a healthcare company focused on life-saving early detection of multiple cancers.
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About Illumina

Illumina develops, manufactures and markets integrated systems for the analysis of genetic variations and biological functions. The company also provides sequencing and array-based solutions for genetic analysis, as well as genotyping, NIPT and whole-genome sequencing services for government laboratories, hospitals, and reference laboratories, among others.

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NGS Oncology Test
TruSight Oncology Comprehensive

TruSight Oncology Comprehensive is an in vitro diagnostic test that uses targeted next-generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina NextSeq 550Dx instrument. The test can be used to detect single nucleotide variants, multi-nucleotide variants, insertions, deletions, and gene amplifications from DNA, and gene fusions and splice variants from RNA. The test also reports a Tumor Mutational Burden (TMB) score and Microsatellite Instability (MSI) status.
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NIPT Test
VeriSeq NIPT Solution v2

The VeriSeq NIPT Solution v2 is an in vitro diagnostic test intended for use as a screening test for the detection of genome-wide fetal genetic anomalies from maternal peripheral whole blood specimens in pregnant women of at least 10 weeks gestation. It uses whole-genome sequencing to detect partial duplications and deletions for all autosomes and aneuploidy status for all chromosomes.
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Sequencing System
NovaSeq X/NovaSeq X Plus

The NovaSeq X and NovaSeq X Plus sequencing systems deliver extraordinary throughput and accuracy to perform data-intensive applications at a production scale. DRAGEN analysis, available onboard or in the cloud, provides award-winning accuracy for rapid, easy-to-use, and efficient genomic data analysis.
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Clinical Laboratory

NGS Oncology Test
TruSight Oncology Comprehensive

TruSight Oncology Comprehensive is an in vitro diagnostic test that uses targeted next-generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina NextSeq 550Dx instrument. The test can be used to detect single nucleotide variants, multi-nucleotide variants, insertions, deletions, and gene amplifications from DNA, and gene fusions and splice variants from RNA. The test also reports a Tumor Mutational Burden (TMB) score and Microsatellite Instability (MSI) status.
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NIPT Test
VeriSeq NIPT Solution v2

The VeriSeq NIPT Solution v2 is an in vitro diagnostic test intended for use as a screening test for the detection of genome-wide fetal genetic anomalies from maternal peripheral whole blood specimens in pregnant women of at least 10 weeks gestation. It uses whole-genome sequencing to detect partial duplications and deletions for all autosomes and aneuploidy status for all chromosomes.
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Sequencing System
NovaSeq X/NovaSeq X Plus

The NovaSeq X and NovaSeq X Plus sequencing systems deliver extraordinary throughput and accuracy to perform data-intensive applications at a production scale. DRAGEN analysis, available onboard or in the cloud, provides award-winning accuracy for rapid, easy-to-use, and efficient genomic data analysis.
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High-Throughput Sequencing Platform
NovaSeq 6000Dx

The NovaSeq 6000Dx is an IVD-compliant high-throughput sequencing instrument for the clinical lab that features dual modes for IVD and RUO applications, opening new possibilities across a range of sample types, sequencing methods, and clinical research applications. It includes a DRAGEN Server paired with the sequencer, enabling streamlined and accurate data analysis, while an intuitive software interface makes it easy to maximize analysis efficiency.
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NGS Reagents
NextSeq 550Dx Reagents

NextSeq 550Dx sequencing reagent kits offer a simplified workflow and high data quality for in vitro diagnostic testing, bringing the power of a high-throughput sequencing system to the benchtop. The kits offer simplified cartridge loading with all required reagents already in the cartridge, delivering powerful sequencing chemistries with as little as 10 minutes of hands-on time.
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Library Prep Kit
Illumina DNA PCR-Free Library Prep

Illumina DNA PCR-Free Library Prep is a high-performing, fast, and integrated workflow for sensitive applications such as human whole-genome sequencing. While accommodating various study requirements, the Illumina DNA PCR-Free workflow delivers consistent insert sizes, uniform coverage, and optimized performance, regardless of DNA input amount or genome size.
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Amplicon Sequencing Kit
TruSeq Custom Amplicon Kit Dx

The TruSeq Custom Amplicon Kit Dx is an FDA-regulated amplicon sequencing kit that enables clinical labs to develop their own next-generation sequencing (NGS) assays for use on the FDA-regulated MiSeqDx and NextSeq 550Dx instruments. The TruSeq Custom Amplicon Kit Dx is validated to ensure consistent performance between lots, enabling long-term assay use, and facilitating change management.
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Colorectal Cancer Assay Kit
Praxis Extended RAS Panel

Praxis Extended RAS Panel is the first FDA-approved NGS in vitro diagnostic for evaluating RAS mutations in colorectal cancer to determine patient eligibility for treatment with Vectibix. The kit assesses 12 codons in KRAS/NRAS to simultaneously determine the presence of 56 activating mutations.
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Cystic Fibrosis Testing Assays
TruSight Cystic Fibrosis

TruSight Cystic Fibrosis is an FDA-regulated, CE-IVD-marked next-generation sequencing test that conveniently provides two cystic fibrosis testing assays in one product. Labs can choose between running the TruSight Cystic Fibrosis 139-Variant Assay or the TruSight Cystic Fibrosis Clinical Sequencing Assay, all from one library preparation.
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SARS-CoV-2 NGS Test
Illumina COVIDSeq Test

The Illumina COVIDSeq Test is a high-throughput, next-generation sequencing test is intended for the detection of SARS-CoV-2 virus RNA in authorized countries and virus genome analysis for research use. This amplicon-based NGS test includes 2019-nCoV primers designed to detect RNA from the SARS-CoV-2 virus in nasopharyngeal, oropharyngeal, and mid-turbinate nasal swabs from patients with signs and symptoms of infection who are suspected of COVID-19.
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Sequencing System
NovaSeq 6000 Sequencing System

The NovaSeq 6000 Sequencing System performs whole-genome sequencing more efficiently and cost-effectively than ever. Its scalable output generates up to 6 Tb and 20 billion reads in dual flow cell mode with simple streamlined automated workflows. The system can be configured to sequence a trio in one day or up to 48 genomes in ~2 days for the most comprehensive coverage.
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Reagent Kits
MiniSeq Reagent Kits

MiniSeq sequencing reagent kits bring the power and reliability of proven Illumina next-generation sequencing (NGS) to labs of all sizes. Users can access cost-efficient sequencing with high data quality, even for low numbers of samples. The kits offer a wide range of solutions for applications ranging from gene expression and small RNA profiling to targeted DNA amplicon sequencing and small genome sequencing. The kit enables faster run times for NGS workflows to improve lab efficiency and provide a quicker time to results.
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Benchtop Sequencer
MiniSeq System

The MiniSeq System is an affordable benchtop sequencer that delivers the power and confidence of proven Illumina next-generation sequencing (NGS) technology in an accessible sequencing solution. It features cost-efficient sequencing, even for low numbers of samples. Its streamlined workflow enables rapid sequencing of both DNA and RNA. The small footprint allows it to fit seamlessly into laboratories, with no need for specialized, ancillary equipment.
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NGS System
iSeq 100 System

The iSeq 100 System is a low cost, RUO only benchtop next generation sequencer that is one cubic feet and includes a mounted 10 inch screen. Leveraging the speed and affordability of complementary metal-oxide-semiconductor (CMOS) technology and the accuracy of sequencing by synthesis (SBS) chemistry, it enables virtually any lab to acquire powerful next-generation sequencing (NGS) technology. The iSeq 100 System is ideal for small whole-genome sequencing (eg, bacteria, viruses, plasmids), targeted sequencing of a set of genes or gene regions, gene expression analysis, or 16S metagenomics.
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NGS System
NextSeq 2000

The NextSeq 2000 next-generation sequencing (NGS) system offers innovative design features, advanced chemistry, simplified bioinformatics, and an intuitive workflow that enable the widest range of applications on a benchtop sequencing system. It uses Illumina’s patterned flow cells, resulting in a highly flexible and scalable benchtop system that offers the highest cluster density flow cell of any on-market NGS system to date, driving down the cost per gigabase (Gb) of the sequencing run.
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SARS-CoV-2 (COVID-19) Test
Illumina COVIDSeq Test

The Illumina COVIDSeq Test is the first NGS test approved for use under the US Food and Drug Administration’s Emergency Use Authorization (EUA). This amplicon-based NGS test includes 2019-nCoV primers designed to detect RNA from the SARS-CoV-2 virus in nasopharyngeal, oropharyngeal, and mid-turbinate nasal swabs from patients with signs and symptoms of infection who are suspected of COVID-19. The test can be run on the Illumina NovaSeq 6000 Sequencing System, NextSeq 500 Sequencing System, NextSeq 550 Sequencing System, or NextSeq 550Dx Instrument.
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NGS System
NextSeq 550Dx

The NextSeq 550Dx is a FDA-regulated and CE-IVD marked next-generation sequencing (NGS) system with dual boot functionality, and includes a diagnostic mode (Dx mode) and a research mode, providing the flexibility to perform both clinical research and develop a range of IVD assays on a single instrument. It offers a validated high-throughput platform for large clinical laboratories, and fully-integrated onboard analysis software with modular software architecture to support current and future assays.
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NGS Test
MiSeqDx Cystic Fibrosis 139-Variant Assay

The MiSeqDx Cystic Fibrosis 139-Variant Assay is an FDA-cleared in vitro diagnostic (IVD) next-generation sequencing test designed to detect 139 CFTR variants. It provides a fully integrated molecular CF testing solution on the MiSeqDx instrument and includes all index primers and reagents needed for library preparation, sample multiplexing, and sequencing in a single kit.
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Reagents
MiSeqDx Universal Kit

The MiSeqDx Universal Kit is a validated, FDA-cleared amplicon sequencing solution that enables clinical laboratories to develop their own next-generation sequencing (NGS) assays for use on the FDA-cleared MiSeqDx instrument. It allows molecular diagnostics labs to develop assays using oligonucleotide probes designed on their own and provides a quick and easy to perform automated workflow to potentially minimize human error.
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Clinical NGS System
MiSeqDx System

The MiSeqDx System is the first FDA-cleared next-generation sequencing (NGS) platform for in vitro diagnostic (IVD) testing that provides accurate, reliable data for screening and diagnostic testing, including assays for cystic fibrosis testing. Designed specifically for clinical laboratories, it delivers a broad range of sequencing applications and provides an easy-to-use, automated workflow for obtaining comprehensive and reliable DNA sequencing results.
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