January 26, 2015 6:30 AM ET


Company Overview of Asuragen, Inc.

Company Overview

Asuragen, Inc., a molecular diagnostics company, discovers, develops, and commercializes molecular-based clinical diagnostic products and clinical testing services used for patient management decisions in oncology, genetic disease, and other molecular testing modalities. Its diagnostic products include KRAS Mutations, used for the multiplex detection and identification of mutations in a single reaction; BRAF Mutations, used for the detection of the mutation using genomic DNA isolated from cultured cells or fresh, frozen, or formalin-fixed paraffin-embedded tissues; LTx v2.0 assay, used for the detection and identification of the fusion transcripts from chromosome translocations/abnormalities...

2150 Woodward Street

Suite 100

Austin, TX 78744

United States

Founded in 2005





Key Executives for Asuragen, Inc.

Chief Executive Officer and President
Chief Financial Officer and Senior Vice President of Corporate Development
Age: 54
Senior Vice President of Operations
Senior Vice President and General Counsel
Compensation as of Fiscal Year 2014.

Asuragen, Inc. Key Developments

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.

Asuragen, Inc. Announces Management Appointments

Asuragen, Inc. announced that it has appointed Matthew McManus, M.D., Ph.D., President and CEO and expanded its senior commercial leadership. Dr. McManus joins Asuragen with more than 20 years of clinical diagnostic leadership experience and was most recently Chief Executive Officer and President of PrimeraDx, Inc. In addition to Dr. McManus, the Company has recently made key commercial additions to its senior leadership team. Darin Leigh has been named Senior Vice President of Commercial Operations, and Eric Lindquist has joined as Vice President of Business Development - Companion Diagnostics. Mr. Leigh has over 23 years of experience in commercial operations within the life science and medical device industry. Prior to Asuragen, Mr. Leigh was Vice President of Global Commercial Operations with Luminex Corporation. Mr. Lindquist has over 15 years of experience in the IVD, diagnostic instrumentation and clinical testing industries.

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