Agena Bioscience

Herston, Australia

Agena Bioscience

Herston, Australia

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News Article | June 20, 2017
Site: www.prnewswire.com

Assurex Health initially selected the MassARRAY System for its laboratory-developed test because it provides a robust, simple, highly cost-effective workflow resulting in faster time-to-result and greater capacity for the laboratory. To date, Assurex Health has run over 150,000 GeneSight tests using the MassARRAY System.  Going forward under the new partnership, Assurex Health expects to significantly increase the number of GeneSight test samples run on the platform. "Agena Bioscience is passionate about providing affordable multiplex molecular systems to laboratories worldwide to help them significantly expand access to clinically relevant genomic data.  Pharmacogenomics testing is a foundational application in the sweet spot for targeted genetic analysis on our MassARRAY System. We are proud to be chosen by Assurex Health, and see the partnership as a significant accelerator into this clinical market segment," said Pete Dansky, Chief Executive Officer at Agena Bioscience. The MassARRAY System enables high-throughput, accurate detection of SNPs, INDELs, and copy number variations across a variety of genetic applications. The flexibility and scalability of the platform facilitates easy development of custom panels and validation across large numbers of samples. Assurex Health Vice President, Laboratory Operations, Sandra Gunselman, Ph.D. commented, "The GeneSight test has seen tremendous adoption and growth, with hundreds of thousands of patients tested. We are committed to providing our customers with rapid turnaround time and scalability that enables us to meet the ever-growing demand for the test. With fewer touch points and less variability in workflow, our team can continue to accelerate service to psychiatrists and their patients." The GeneSight Psychotropic test is supported by five published clinical studies demonstrating its efficacy and cost effectiveness.  For more information visit www.genesight.com. Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY® System. The system is a highly sensitive, cost-effective, mass spectrometry-based platform for high-throughput genetic analysis, and is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research.  For more information about Agena, visit www.agenabio.com. Assurex Health, a wholly-owned subsidiary of Myriad Genetics, Inc., is an informatics-based, personalized medicine company providing treatment decision support to healthcare providers for behavioral health and chronic pain conditions. Assurex helps people achieve mental wellness with advanced CPGx®, a proprietary combinatorial pharmacogenomics technology that provides individualized treatment support for neuropsychiatric conditions.   Assurex Health is the only company in the category with multiple peer-reviewed, published studies that demonstrate the clinical validity and clinical utility of the GeneSight® test, including its substantial healthcare cost savings benefit. The Company has grown every quarter and has expanded internationally through a partnership with Canada's Centre for Addiction and Mental Health (CAMH). For more on how Assurex Health is helping people gain mental wellness, visit www.AssurexHealth.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/agena-bioscience-announces-expanded-partnership-with-assurex-health-300475523.html


The MassARRAY Dx product offers clinical laboratories a unique combination of reliability, sensitivity, ease of use, and cost-effectiveness for targeted genetic testing.  The multiplexing feature of MassARRAY supports assays that interrogate multiple biomarkers in a single reaction, which reduces the cost and turnaround time compared with other diagnostic methods.  The system enables high-throughput, accurate detection of SNPs, INDELs, and copy number variations across a variety of genetic applications, including mutation profiling for solid tumors and highly sensitive liquid biopsy analysis, and comprehensive pharmacogenomics profiling. The flexibility and scalability of the platform facilitate easy development of custom panels and validation across large numbers of samples. "This is good news and a new step for this high performing in vitro diagnostic (IVD) device. It will facilitate implementation in clinical labs and accreditation," said Dr.Pierre-Jean Lamy, Directeur Général, Biologiste Médical at Labosud Oc Biologie. "This is another great milestone in Agena's global strategy to grow the clinical business by offering laboratories a highly effective diagnostic platform that can support the rapidly evolving needs of this market," said Peter Dansky, Chief Executive Officer of Agena Bioscience. "In addition to the well-established performance of the MassARRAY System, the Chip Prep Module now adds increased ease-of-use to the overall workflow." The new CE-IVD marked MassARRAY System with Chip Prep Module joins the company's growing line of in vitro diagnostic devices for certain European countries, including the MassARRAY Dx Analyzer 4, MassARRAY Dx Nanodispenser, MassARRAY Dx Colon Panel and MassARRAY Dx Lung Panel. These are sold exclusively in Europe for diagnostic use, and are not available for sale in the United States. Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY® System. The system is a highly sensitive, cost-effective, mass spectrometry-based platform for high-throughput genetic analysis, and is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research.  For more information about Agena, visit www.agenabio.com.


The MassARRAY Dx product offers clinical laboratories a unique combination of reliability, sensitivity, ease of use, and cost-effectiveness for targeted genetic testing.  The multiplexing feature of MassARRAY supports assays that interrogate multiple biomarkers in a single reaction, which reduces the cost and turnaround time compared with other diagnostic methods.  The system enables high-throughput, accurate detection of SNPs, INDELs, and copy number variations across a variety of genetic applications, including mutation profiling for solid tumors and highly sensitive liquid biopsy analysis, and comprehensive pharmacogenomics profiling. The flexibility and scalability of the platform facilitate easy development of custom panels and validation across large numbers of samples. "This is good news and a new step for this high performing in vitro diagnostic (IVD) device. It will facilitate implementation in clinical labs and accreditation," said Dr.Pierre-Jean Lamy, Directeur Général, Biologiste Médical at Labosud Oc Biologie. "This is another great milestone in Agena's global strategy to grow the clinical business by offering laboratories a highly effective diagnostic platform that can support the rapidly evolving needs of this market," said Peter Dansky, Chief Executive Officer of Agena Bioscience. "In addition to the well-established performance of the MassARRAY System, the Chip Prep Module now adds increased ease-of-use to the overall workflow." The new CE-IVD marked MassARRAY System with Chip Prep Module joins the company's growing line of in vitro diagnostic devices for certain European countries, including the MassARRAY Dx Analyzer 4, MassARRAY Dx Nanodispenser, MassARRAY Dx Colon Panel and MassARRAY Dx Lung Panel. These are sold exclusively in Europe for diagnostic use, and are not available for sale in the United States. Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY® System. The system is a highly sensitive, cost-effective, mass spectrometry-based platform for high-throughput genetic analysis, and is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research.  For more information about Agena, visit www.agenabio.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/agena-bioscience-launches-ce-ivd-system-for-hospitals-and-diagnostic-laboratories-in-europe-300481532.html


News Article | July 18, 2017
Site: www.prnewswire.com

HEARTDECODE® Software und speziell zur Verwendung mit dem MassARRAY® DX-System entwickelte Assays SAN DIEGO, 18. Juli 2017 /PRNewswire/ -- Agena Bioscience gab heute eine Co-Marketing-Vereinbarung zur Nutzung seiner klinischen Diagnosetechnik MassARRAY® DX zusammen mit den Produkten...


News Article | July 18, 2017
Site: www.prnewswire.com

The MassARRAY DX, a CE-IVD marked system, provides a streamlined and cost-effective workflow for labs enabling parallel analysis of mutations (SNPs, InDels, rearrangements and copy number variants). Tens to hundreds of medically-actionable or known predictive genetic variants can be screened across 100s of patient samples in a single day. The flexibility and scalability of the platform permit mid- to large-scale sample throughput which provides the means for highly efficient lab production. As a leader in genetic tests and computational tools designed to support clinical diagnosis and the prevention of cardiovascular disease, HeartGenetics will provide HEARTDECODE® software and assays designed for use with the MassARRAY System. HEARTDECODE® software provides highly accurate and reproducible analysis with the integration of both genetic and pharmacogenetics data and medical guidelines. "Computational biology companies with clinical expertise are crucial for realizing the full potential of personalized medicine. We are proud that HeartGenetics, one of the key entrepreneurs in digital health care, has chosen to partner with Agena," said David Coorey, Vice President and General Manager, EMEA at Agena Bioscience. HeartGenetics, a spin-off from Tecnico Lisboa, has developed new certified CE-IVD medical devices, which include genetic tests and AI software tools for data interpretation, to assess the individual risk for conditions such as Hereditary Thrombophilia (TRB), Arterial Hypertension (AHTN), Hypertrophic Cardiomyopathy (HCM), and Familial Hypercholesterolemia (FH). Additionally, the clinically relevant genetics tests of Warfarin, Clopidogrel and Simvastatin pharmacogenetics are included. Ana Teresa Freitas, Chief Executive Officer of HeartGenetics, commented, "We are excited to have the opportunity to partner with Agena Bioscience, whose MassARRAY technology provides an ideal platform for robust, cost-effective clinical diagnostics. Together we will be able to promote cardiovascular health to many patients with accurate, actionable and affordable testing." Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY® System. The system is a highly sensitive, cost-effective, mass spectrometry-based platform for high-throughput genetic analysis, and is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research. In the United States, the MassARRAY System is intended for research use only, and not intended for use in diagnostic procedures. In Europe, the MassARRAY Dx by Agena Bioscience is a CE-IVD marked genetic analysis system that enables reliable multiplexed analysis of up to hundreds of clinically relevant mutations in a single workflow. Powered by sensitive and accurate mass-based detection, the MassARRAY Dx maximizes laboratory resources with rapid turnaround time and clinically actionable mutation reports. www.agenabio.com HeartGenetics, Genetics and Biotechnology SA is a Portuguese biotech and bioinformatics company developing new medical devices (genetic testing kits and AI software tools) that makes genetic testing simple, actionable and cost-effective and that can be used on cardiovascular diagnosis, pharmacogenetics and nutrigenetics. www.heartgenetics.com


News Article | July 18, 2017
Site: www.prnewswire.co.uk

The MassARRAY DX, a CE-IVD marked system, provides a streamlined and cost-effective workflow for labs enabling parallel analysis of mutations (SNPs, InDels, rearrangements and copy number variants). Tens to hundreds of medically-actionable or known predictive genetic variants can be screened across 100s of patient samples in a single day. The flexibility and scalability of the platform permit mid- to large-scale sample throughput which provides the means for highly efficient lab production. As a leader in genetic tests and computational tools designed to support clinical diagnosis and the prevention of cardiovascular disease, HeartGenetics will provide HEARTDECODE® software and assays designed for use with the MassARRAY System. HEARTDECODE® software provides highly accurate and reproducible analysis with the integration of both genetic and pharmacogenetics data and medical guidelines. "Computational biology companies with clinical expertise are crucial for realizing the full potential of personalized medicine. We are proud that HeartGenetics, one of the key entrepreneurs in digital health care, has chosen to partner with Agena," said David Coorey, Vice President and General Manager, EMEA at Agena Bioscience. HeartGenetics, a spin-off from Tecnico Lisboa, has developed new certified CE-IVD medical devices, which include genetic tests and AI software tools for data interpretation, to assess the individual risk for conditions such as Hereditary Thrombophilia (TRB), Arterial Hypertension (AHTN), Hypertrophic Cardiomyopathy (HCM), and Familial Hypercholesterolemia (FH). Additionally, the clinically relevant genetics tests of Warfarin, Clopidogrel and Simvastatin pharmacogenetics are included. Ana Teresa Freitas, Chief Executive Officer of HeartGenetics, commented, "We are excited to have the opportunity to partner with Agena Bioscience, whose MassARRAY technology provides an ideal platform for robust, cost-effective clinical diagnostics. Together we will be able to promote cardiovascular health to many patients with accurate, actionable and affordable testing." Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY® System. The system is a highly sensitive, cost-effective, mass spectrometry-based platform for high-throughput genetic analysis, and is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research. In the United States, the MassARRAY System is intended for research use only, and not intended for use in diagnostic procedures. In Europe, the MassARRAY Dx by Agena Bioscience is a CE-IVD marked genetic analysis system that enables reliable multiplexed analysis of up to hundreds of clinically relevant mutations in a single workflow. Powered by sensitive and accurate mass-based detection, the MassARRAY Dx maximizes laboratory resources with rapid turnaround time and clinically actionable mutation reports. www.agenabio.com HeartGenetics, Genetics and Biotechnology SA is a Portuguese biotech and bioinformatics company developing new medical devices (genetic testing kits and AI software tools) that makes genetic testing simple, actionable and cost-effective and that can be used on cardiovascular diagnosis, pharmacogenetics and nutrigenetics. www.heartgenetics.com


News Article | July 18, 2017
Site: www.prnewswire.com

HEARTDECODE® Software y ensayos diseñados para utilizarse con el Sistema MassARRAY® DX SAN DIEGO, 18 de julio de 2017 /PRNewswire/ -- Agena Bioscience hoy ha anunciado un acuerdo de promoción conjunta que aprovecha su tecnología de diagnóstico clínico MassARRAY® DX con productos...


News Article | July 18, 2017
Site: www.prnewswire.com

MassARRAY DX, système marqué CE-IVD, est l'assurance d'un processus rentable et simplifié pour les laboratoires effectuant des analyses parallèles de mutations (SNP, indels, réorganisations et variabilité du nombre de copies). Il est ainsi possible en un seul jour de passer en revue des dizaines voire des centaines de variants génétiques prédictifs ou pertinents sur le plan médical sur des centaines d'échantillons de patients. Flexible et évolutive, la plateforme offre un débit d'échantillons moyen à élevé, pour une production hautement efficace en laboratoire. En tant que leader dans les tests génétiques et les outils informatiques conçus pour appuyer les diagnostics cliniques et la prévention des maladies cardiovasculaires, HeartGenetics fournira le logiciel et les analyses HEARTDECODE®, qui ont été spécialement conçus pour le système MassARRAY. Le logiciel HEARTDECODE® offre une analyse extrêmement précise et reproductible avec l'intégration de données génétiques et pharmacogénétiques et de directives médicales. HeartGenetics, entreprise essaimée de Tecnico Lisboa, a développé de nouveaux dispositifs médicaux marqués CE-IVD, avec notamment des tests génétiques et des outils logiciels d'IA pour l'interprétation des données, et ce, afin d'évaluer les risques pour un individu de contracter des maladies telles que la thrombophilie héréditaire (TRB), l'hypertension artérielle (HTA), la cardiomyopathie hypertrophique (CMH), et l'hypercholestérolémie familiale (HF). Pertinents sur le plan clinique, les tests pharmacogénétiques de la warfarine, du clopidogrel et de la simvastatine sont également inclus. Agena Bioscience conçoit, fabrique et fournit des systèmes et réactifs d'analyse génétique, notamment le système MassARRAY®. Ce système est une plateforme ultrasensible et rentable basée sur la spectrométrie de masse, qui fournit des analyses génétiques à haut rendement. Il est utilisé dans le monde entier dans divers domaines de recherche comme le profilage des tumeurs solides et les biopsies liquides, le dépistage de maladies génétiques héréditaires, la pharmacogénétique, l'agrogénomique et la recherche clinique. En Europe, le MassARRAY Dx d'Agena Bioscience est un système d'analyse génétique marqué CE-IVD qui permet en un seul processus une analyse multiplexe fiable de jusqu'à des centaines de mutations pertinentes sur le plan clinique. Grâce à une détection sensible et précise basée sur la masse, le MassARRAY Dx optimise les ressources des laboratoires avec des temps de traitement réduits et des rapports de mutation pertinents sur le plan clinique. www.agenabio.com HeartGenetics, Genetics and Biotechnology SA est une entreprise portugaise de biotechnologie et de bio-informatique qui conçoit de nouveaux dispositifs médicaux (kits de dépistage génétique et outils logiciels d'IA), pour un dépistage génétique simplifié, pratique et rentable. Ces dispositifs peuvent être utilisés pour les diagnostics cardiovasculaires, en pharmacogénétique et en nutrigénétique. www.heartgenetics.com


News Article | August 2, 2017
Site: www.prnewswire.com

In 2008, the state of Illinois announced the expansion of their newborn screening program to include testing for CF. At the time, it was one of only eighteen states to test for the recommended ACMG/ACOG CF transmembrane conductance regulator (CFTR) variants.  Since then, the diverse population of the state drove the need to explore development of expanded CFTR mutation profiles for the newborn screening program.  IDPH will be expanding their panel to now include 70 CFTR variants. "We are proud to have the MassARRAY System chosen to be an integral part of one of the top newborn screening programs in the country," said Pete Dansky, Chief Executive Officer at Agena Bioscience.  "As we observed in this instance, genetic testing panels may need to evolve to account for a number of factors, including changes in the regional population.  The flexibility of the MassARRAY System will be able to support front-line laboratories such as IDPH to meet the public need for years to come." Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY® System. The system is a highly sensitive, cost-effective, mass spectrometry-based platform for high-throughput genetic analysis, and is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research.  For more information about Agena, visit www.agenabio.com. The mission of the Illinois Department of Public Health is to promote health through the prevention and control of disease and injury. IDPH, one of the state's oldest agencies founded in 1877, has an annual budget of about $325 million in state and federal funds, and has headquarters in Springfield and Chicago, seven regional offices located around the state, three laboratories and 1,100 employees. IDPH forms a frontline defense against disease through preventive measures and education.  To learn more about IDPH, visit http://www.dph.illinois.gov/


PubMed | University Hospital of Tuebingen, Karolinska Institutet, Translational Software, Stanford University and 29 more.
Type: Journal Article | Journal: Clinical pharmacology and therapeutics | Year: 2016

This article provides nomenclature recommendations developed by an international workgroup to increase transparency and standardization of pharmacogenetic (PGx) result reporting. Presently, sequence variants identified by PGx tests are described using different nomenclature systems. In addition, PGx analysis may detect different sets of variants for each gene, which can affect interpretation of results. This practice has caused confusion and may thereby impede the adoption of clinical PGx testing. Standardization is critical to move PGx forward.

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