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August 27, 2015 8:34 PM ET

Healthcare Equipment and Supplies

Company Overview of Asuragen, Inc.

Company Overview

Asuragen, Inc., a molecular diagnostics company, provides patient management solutions in oncology and genetic disorders. The company discovers, develops, and commercializes diagnostic products for use in clinical laboratories and bio/pharma partners’ diagnostic needs. It offers diagnostic products and services, which include AmplideX FMR1 PCR reagents operates as a research tools for the detection of CGG repeats in the fragile X mental retardation (FMR1) gene; AmplideX FMR1 mPCR reagents that employ an PCR-only approach for the detection of methylation status in the FMR1 gene; AmplideX FMR1 Controls, which are mixtures of genomic DNA containing multiple alleles; Analyte specific reagents; a...

2150 Woodward Street

Suite 100

Austin, TX 78744

United States

Founded in 2005

Phone:

512-681-5200

Fax:

512-681-5201

Key Executives for Asuragen, Inc.

Chief Executive Officer and President
Founder and Chairman
Age: 63
Chief Financial Officer and Senior Vice President of Corporate Development
Age: 55
Senior Vice President of Operations
Senior Director of Clinical Affairs, Regulatory and Quality
Compensation as of Fiscal Year 2015.

Asuragen, Inc. Key Developments

Asuragen, Inc. Announces the Launch of the Quantidex™ Pan Cancer Kit

Asuragen, Inc. announced the launch of the Quantidex™ Pan Cancer Kit. This next-generation sequencing (NGS) oncology panel offers a comprehensive workflow solution that integrates reagents, controls, and a novel bioinformatics suite for the sequencing of 21 genes relevant to a diverse set of human cancers. The technology builds upon Asuragen’s extensive experience in the NGS space and is optimized for the reliable interrogation of difficult sample types, such as formalin-fixed paraffin embedded (FFPE) and fine-needle aspiration (FNA) tissues. Incorporating a modular workflow design that can expedite content expansion, this approach includes the assimilation of both DNA and RNA targets, and provides a complete targeted NGS solution for laboratories wishing to adopt NGS. Although NGS offers advantages for sample multiplexing, high analytical sensitivity, and the ability to profile a large number of potentially clinically-actionable biomarkers in a single test, the complexities of incorporating an NGS workflow pose a barrier for many laboratories to overcome. The Quantidex™ Pan Cancer Kit provides a streamlined wet-bench protocol and companion “push-button” analysis software that facilitates rapid training and implementation, even for laboratories with little to no NGS experience or informatics infrastructure. In addition, the product unifies pre-analytical DNA QC, sample quantification, multiplex PCR enrichment, dual-index barcoding, and library purification and quantification using reagents provided in a single kit.

Asuragen, Inc. Launches the Quantidex DNA to Improve the Accuracy of Next-Generation Sequencing

Asuragen, Inc. announced the launch of the Quantidex DNA Assay at the Association for Molecular Pathology (AMP) Annual Meeting in National Harbor, MD. This product quantifies absolute copy numbers of genomic DNA, flags PCR inhibitors from the sample, and reports functional DNA quality from challenging specimens such as FFPE tumor biopsies using the QFI Score to increase the reliability and accuracy of next-generation sequencing (NGS) assays. The Quantidex DNA assay provides the QFI Score, which is the percentage of amplifiable DNA in a sample, and the number of amplifiable DNA copies to help guide inputs into NGS target enrichment to optimally balance DNA consumption with data quality. This information can guard against failed NGS runs, reduce the number of erroneous variant calls, and minimize the burden of confirmation testing. The assay also flags PCR inhibitors in the sample and creates opportunities to salvage such samples through a subsequent clean-up step prior to further processing. Finally, the assay procedure offers a simple and convenient workflow with pre-diluted and ready to use standards for ease of use and high reproducibility from laboratory-to-laboratory. The Quantidex DNA Assay has been evaluated with >2000 FFPE and FNA tumor biopsy samples and utilized in four peer-reviewed publications to date.

Asuragen and Labceutics Report Results from Pan European Quality Assurance-Modeled Study on Standardization of BCR-ABL1 Monitoring for CML Patients

Asuragen and Labceutics announced the publication of the results from the first international, multi-center quality assurance study on the standardization of BCR-ABL1 quantitative measurements on the International Scale (IS). The double-blinded study assessed the variability of BCR-ABL1 testing by quantitative reverse transcription PCR (RT-qPCR) across 15 clinical laboratories performing routine monitoring of chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs) in five European countries. The data demonstrate that the use of secondary IS reference materials anchored to the primary IS reference standards of the World Health Organization, the ARQ IS(TM) Calibrator Panels, can improve the precision and accuracy of BCR-ABL1 testing. The study results were initially reported at the 15(th) International Conference on CML organized by the European School of Haematology and the International Chronic Myeloid Leukemia Foundation in Estoril, Portugal, and were published by the College of American Pathologists in Archives of Pathology & Laboratory Medicine. The ARQ IS Calibrator Panels consist of precisely quantified and nuclease resistant RNA molecules based on Asuragen's proprietary Armored RNA Quant(R) technology. The commutability of these panels and their utility as secondary IS reference materials have previously been validated in an independent international collaborative study published in 2013 by the American Association of Clinical Chemistry.

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