October 30, 2014 2:13 PM 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
Age: 54
Senior Vice President and General Counsel
Senior Vice President of Commercial Operations
Compensation as of Fiscal Year 2014.

Asuragen, Inc. Key Developments

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.

Asuragen Receives New York State License for Molecular Genetic and Oncology Clinical Laboratory Testing

Asuragen, Inc. announced that it had received a clinical laboratory permit from the state of New York to offer Xpansion Interpreter, its reflex test for fragile X carriers and miRInform Thyroid for use in the management of patients with thyroid nodules. With this approval, Asuragen can now offer its CAP-certified CLIA laboratory Xpansion Interpreter and miRInform Thyroid Tests in all 50 states. Fragile X syndrome is the most common inherited cause of intellectual disability and autism. The likelihood of having a child with fragile X syndrome is linked to the number of CGG repeats and the number of AGG interruptions in the Fragile X Mental Retardation (FMR1) gene. Xpansion Interpreter is the first clinically available laboratory-developed FMR1 test that determines the total number of CGG repeats and number of AGG interruptions. Xpansion Interpreter can aid in personalizing the risk for at-risk patients of having a child with fragile X syndrome. Features of fragile X syndrome vary widely but can include mild to severe cognitive delays, seizures, behavioral differences such as perseverative speech and hand flapping, and characteristic facial features such as large ears and a long face. About 1 in 4,000 males and 1 in 8,000 females has fragile X syndrome. The molecular basis for fragile X syndrome is an increased number of trinucleotide CGG repeats in the 5' promoter region of the FMR1 gene. FMR1 alleles can be further categorized based on the number of CGG repeats, and premutation alleles may expand from parent to child to a full mutation that can cause features of fragile X syndrome. In addition, people with premutations may develop fragile X-associated Tremor/Ataxia Syndrome and women may develop fragile X-associated Primary Ovarian Insufficiency.

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Recent Private Companies Transactions

August 13, 2014
Asuragen, Inc., MiRInform Thyroid and Pancreas Cancer Test Portfolio

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