Asuragen to Present at Upcoming 2015 Association for Molecular Pathology Annual Meeting in Austin, TX

New Data on Asuragen’s QuantideX® NGS Targeted Panels and Oncology Disease Monitoring

Austin, Texas – November 3, 2015 – Asuragen, Inc., a global molecular diagnostics company, will be presenting extensive new data at the upcoming Association for Molecular Pathology (AMP) 21st Annual Meeting, November 4-7, 2015 in Austin, TX. The presentations by Asuragen scientists and scientific collaborators will cover the latest technologies and advances in genetic disease testing, oncology disease monitoring, as well as NGS profiling of solid and liquid biopsies.

“Our company is focused on delivering innovative solutions in genetics and oncology through our AmplideX® and QuantideX® product lines, respectively. Earlier this year, we launched a pan cancer gene panel with the industry’s first complete end-to-end NGS workflow solution for oncology disease profiling. We are also extending our leadership positions in disease monitoring assays such as chronic myeloid leukemia (CML), and in complex genetic disease testing such as fragile X,” said Matthew McManus, MD, PhD, President and CEO of Asuragen. “These innovations are fundamental to our mission of delivering on the promise of personalized medicine and position us at the forefront of molecular diagnostics.”

At the 2015 AMP Meeting, Asuragen will host two corporate workshops on NGS-based assays for pan cancer and lung cancer diseases, as well as a new BCR-ABL monitoring assay for CML. These workshops will be held on Nov. 4th at the Austin Convention Center, and will feature presentations from Asuragen scientists and collaborators describing the latest data generated with QuantideX® assays and products.

In the first session on NGS, Ravindra Kolhe, MD, PhD, a clinical and anatomic Pathologist and Medical Director of the Cytogenetics Laboratory at Georgia Regents University, will present the results of a multi-laboratory NGS study using the new QuantideX® NGS Pan Cancer Kit (RUO)*. Additionally, Gary Latham, PhD, Vice President of Research at Asuragen, will present his team’s latest findings from a new targeted RNA-seq panel for lung cancer rearrangements that includes ALK, ROS1, and RET fusions. In the second workshop, Andrea Ferreira-Gonzalez, PhD, Chair of the Molecular Diagnostics Division, Virginia Commonwealth University, will present validation data for the QuantideX® qPCR BCR-ABL IS Kit (CE-IVD)** for monitoring therapeutic response of CML patients.

Asuragen’s products and technologies will also be featured in 11 scientific posters by Asuragen and its extensive network of collaborators, at sessions on genetics, informatics, solid tumors, and technical topics. The breadth of these scientific outputs from Asuragen reflects the company’s focus on delivering innovative solutions that address many current challenges in genetics and oncology. Highlights from these posters are provided below:

“An Integrated System for Targeted Next-Generation Sequencing that Enables Simultaneous Analysis of DNA Mutations, RNA Fusions and Gene Expression in Residual Clinical FFPE, FNA, and Liquid Biopsies” (Abstract No. ST64); describes an innovative method for combined DNA- and RNA-based NGS analysis in FFPE and FNA specimens from thyroid and lung cancers, and presents results from analyses with >200 clinical samples.

“A Quantitative PCR-based Assay Shows Superior Reproducibility Compared to Fluorescence- based DNA Quantification: An Inter-laboratory Study”(Abstract No. TT10); details the superior inter-laboratory reproducibility of a qPCR-based DNA quantification and QC assay compared to a common fluorescence-based assay using 120 blinded samples.

“A Competitive qPCR Assay Eliminates the Need for a Calibration Curve and Enables Streamlined Quantification and Normalization of Targeted Next-Generation Sequencing Libraries” (Abstract No. TT26); compares and contrasts 3 methods for NGS library quantification, including a relative competitive qPCR-based assay that does not require a calibration curve and offers a fast and simple workflow.

“High-Resolution Amplification and Genotyping Technologies for Pre-Implantation Genetic Diagnosis of Fragile X Syndrome from Single Cells” (Abstract No. G09); presents novel workflows for FMR1 genotyping from single cells for PGD applications using both pre- amplification and direct PCR methods.

“Automated Fragment Size Analysis of AmplideX® PCR/CE FMR1 PCR Products Improves Interpretive Accuracy and Reduces Turn-Around Time” (Abstract No. I17); describes a software solution for automated fragile X repeat genotype analysis, including built-in QC checks, and reliable minor allele detection, that was trained and tested using >1000 CGG profiles.

“QuantideX® NGS Reporter: Push-Button, Specimen-Aware Bioinformatics that Integrates Pre-Analytical QC Data to Optimize Variant Detection in Residual Clinical FFPE, FNA, and Liquid Tumor Biopsies” (Abstract No. I19); discusses a standalone bioinformatics suite for targeted NGS that integrates wet-lab and dry-bench processes to enhance sensitivity and specificity for DNA and RNA analyses using challenging oncology specimens.

“Comparisons of Three Targeted Next-Generation Sequencing Commercial Kits Using FFPE Tumor DNA Exposes Differences in Specimen Compatibility, Sample QC, Workflow, and Turn- Around Time” (Abstract No. ST29); compares and contrasts workflows, sample QC, and analytical performance among three sets of pan- cancer, targeted NGS commercial reagents across a set of 60 residual clinical FFPE tumor biopsies.

“Digital PCR Complements and Confirms Low-Abundance Resistance Mutations Identified by Targeted Next-Generation Sequencing in a Pre-Clinical Model of Acquired Resistance Using a Novel Mutant EGFR Inhibitor” (Abstract No. ST51); characterizes emergent low-level EGFR mutations, and EGFR and MET copy number variants, by both ddPCR and targeted NGS, and discusses precision medicine implications for variants associated with drug resistance.

“A Comprehensive Multi-site Evaluation of the QuantideX® NGS Pan Cancer Kit Yields Repeatable and Reproducible NGS Analysis of Low-Quantity FFPE Tumor Biopsies” (Abstract No. ST89); presents a 3-site evaluation of the training, workflow, and performance of a new, commercially- available, targeted NGS panel kit with included reagents, controls, and bioinformatics.

“CTC-Seq: Accurate Mutation Detection from Single Cancer Cells Using the CellSearch® System and QuantideX® Targeted NGS Panels” (Abstract No. TT07); describes proof-of-concept for a CellSearch®-compatible protocol that enables accurate NGS-based mutation detection from 1-20 cancer cells.

“Choice of FFPE DNA Isolation Method Affects Both Yield and Functional Quality and Impacts Variant Calling by Targeted NGS” (Abstract No. TT27); highlights differences in function yield among different FFPE DNA isolation methods, including a novel extraction based on isotachophoresis, and discusses the implications of each on accurate NGS profiling.

For more information on Asuragen’s activities at the AMP Annual Meeting, visit or stop by booth #1123.

* Research Use Only. Not for use in diagnostic procedures
** CE-IVD. Export Only. Not available for diagnostic procedures in the USA.

About Asuragen
Asuragen is a global diagnostic products company delivering solutions that build knowledge and understanding of complex clinical questions. Asuragen’s application of its deep scientific heritage and molecular expertise delivers diagnostic products in oncology and genetics that provide the best answers with optimal workflows – so time can be spent delivering actionable insights, rather than searching for them. With innovative approaches to kit development and a broad range of molecular chemistries, Asuragen produces assays that ensure reproducible results. From discovery to development to regulatory support to global commercialization, we provide a tailored approach that efficiently delivers custom and companion diagnostic products for our partners. We believe people deserve better answers. For more information, visit

Lynne Hohlfeld
SVP, Corporate Development and CFO
Asuragen, Inc.
T: 512.681.5200


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