Austin, Texas – Date: November 11, 2014 – Asuragen, Inc. announced today the launch of the QuantideX^® qPCR DNA QC 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.

A key problem for NGS assays of challenging clinical samples is that the two methods that are most commonly used by laboratories to quantify DNA, spectrophotometry and fluorescence-dye binding assays, may not reliably report the DNA that is actionable in target enrichment assays. This limitation is particularly problematic for FFPE and FNA cancer specimens that suffer from chemical modifications, fragmentation, or low DNA yields that impact DNA quality and quantity. Spectrophotometry is insensitive to DNA quality, and dye-binding assays fail to discriminate among the low-quality samples that are commonly observed with FFPE biopsies. The disconnect between DNA quantification and DNA actionability can lead to failed NGS runs and delayed turnaround-times, or, worse, false-positive and -negative calls. The QuantideX^® DNA Assay reports amplifiable DNA, rather than bulk DNA, and predicts performance in targeted NGS assays that rely on similar enzymatic methods to generate target-enriched, sequenceable libraries.

The Quantidex^® qPCR DNA QC 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^® qPCR DNA QC Assay has been evaluated with >2000 FFPE and FNA tumor biopsy samples and utilized in four peer-reviewed publications to date. “Even well-designed, targeted NGS assays are vulnerable to library failures and inaccuracies in variant calling when used with low-quality and low-quantity DNA specimens. The QuantideX^® qPCR DNA QC Assay can help prevent these NGS dilemmas before they begin, and offers a simple-to-implement, cost-effective, and quantitative tool that should be a part of any truly integrated NGS workflow solution. Asuragen looks forward to providing additional NGS products that can support this goal,” said Gary Latham, VP of Research and Technology Development at Asuragen.

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Media Contact
Lynne Hohlfeld
SVP, Corporate Development and Chief Financial Officer
Asuragen, Inc.
512.681.5200
lhohlfeld@asuragen.com