September 21, 2017 11:44 PM ET

Healthcare Equipment and Supplies

Company Overview of Asuragen, Inc.

Company Overview

Asuragen, Inc., a molecular diagnostics company, offers patient management solutions in oncology and genetic disorders. It discovers, develops, and commercializes diagnostic products for use in clinical laboratories and bio/pharma partners’ diagnostic needs. It offers diagnostic products and services that include AmplideX FMR1 PCR reagents for the detection of CGG repeats in fragile X mental retardation (FMR1) gene; AmplideX FMR1 mPCR reagents for the detection of methylation status in the FMR1 gene; AmplideX FMR1 Controls that are mixtures of genomic DNA containing multiple alleles; Analyte specific reagents; AmplideX PCR/CE FMR1 Reporter, a software system that reports the sizing of the FM...

2150 Woodward Street

Suite 100

Austin, TX 78744

United States

Founded in 2005





Key Executives for Asuragen, Inc.

Chief Executive Officer, President and Director
Founder and Chairman
Age: 65
Chief Financial Officer and Senior Vice President of Corporate Development
Age: 57
Senior Vice President of Operations
Senior Vice President of Research and Development
Compensation as of Fiscal Year 2017.

Asuragen, Inc. Key Developments

Asuragen, Inc. Announces Availability of QuantideX® qPCR BCR-ABL Minor Kit

Asuragen, Inc. announced the availability of their CE-marked QuantideX® qPCR BCR-ABL minor Kit. Building on its FDA-cleared and CE-marked QuantideX® qPCR BCR-ABL IS Kit for quantifying Major (e13a2, e14a2) BCR-ABL1 fusion transcripts in patients with chronic myeloid leukemia (“CML”), the addition of the QuantideX® qPCR BCR-ABL minor Kit allows laboratories to also quantify minor (e1a2) BCR-ABL1 fusion transcripts. Asuragen’s products are diagnostic systems composed of proprietary chemistry and software to deliver powerful answers using broadly installed instrument platforms. The simplicity, reliability and performance of its tests make it easy for laboratories to adopt. The QuantideX® BCR-ABL Portfolio provides laboratories with robust, reliable and comprehensive solutions for monitoring leukemia patients, allowing them to keep pace with advances in tyrosine-kinase inhibitor (“TKI”) therapy. Key benefits of the kits include unsurpassed sensitivity, simplified workflow, multiplexed assay design using a single reaction to amplify and detect both fusion transcripts and controls, and Armored RNA®-based standards that provide an accurate RNA quantification. The QuantideX® qPCR BCR-ABL IS Kit and QuantideX® qPCR BCR-ABL minor Kitoffer validated clinical sensitivities that detect residual amounts of disease down to 0.002% IS (MR4.7 LOD) and 0.0025% ratio (LR4.61), respectively, both determined using human RNA. The simple, streamlined and common workflow of both kits permits laboratories of all sizes to offer high quality, routine BCR-ABL1 testing. As part of the diagnostic system, Asuragen will also be expanding the capabilities of QuantideX® Reporter, the analysis software that accompanies the CE-marked QuantideX® qPCR BCR-ABL IS Kit, to allow laboratories access to exceptional clinical sensitivity for reporting CML patient disease burden on the International Scale (“IS”) after reviewing ABL1 copy number, compliant with European LeukemiaNet (“ELN”) guidelines.

Asuragen, Inc. Launches the AmplideX® PCR/CE TOMM40 Kit

Asuragen, Inc. announced the availability of the AmplideX® PCR/CE TOMM40 Kit for research use only to advance studies of neurodegeneration, dementia progression, and Alzheimer’s disease (AD). The launch of the AmplideX® PCR/CE TOMM40 Kit1 provides researchers with the first ever, easy to use, reproducible, and accurate tool that can help unlock the potential value of the TOMM40 gene in AD. The kit builds on the success of Asuragen’s AmplideX® PCR/CE FMR1 and C9orf72 Kits, enabling researchers to overcome the challenges of high homology sequences and reveal definitive genotypes from repetitive DNA.

Asuragen and Thermo Fisher Scientific to Collaborate on Diagnostic Kits for 3500 Dx Series Genetic Analyzer

Asuragen, Inc. announced that it has entered into a collaboration agreement with Thermo Fisher Scientific for the development and commercialization of capillary electrophoresis-based in vitro diagnostics (IVDs). Asuragen will leverage its AmplideX PCR/CE product technologies to develop diagnostic kits for the 3500 Dx Series Genetic Analyzer CS2 instrument. Asuragen's kits for PCR/CE provide unparalleled performance for analyzing repetitive sequences. In addition, they integrate Asuragen's analytics and reporting suite, the AmplideX Reporter, providing a straightforward sample-to-answer solution.

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