AUSTIN, Texas--(BUSINESS WIRE)--Asuragen, Inc., a global molecular diagnostics company, announced today the launch of the Quantidex™ Pan Cancer Kit.* This next-generation sequencing (NGS) oncology panel offers a comprehensive workflow solution that integrates reagents, controls, and a novel bioinformatics suite for the sequencing of 21 genes relevant to a diverse set of human cancers.
The technology builds upon Asuragen’s extensive experience in the NGS space and is optimized for the reliable interrogation of difficult sample types, such as formalin-fixed paraffin embedded (FFPE) and fine-needle aspiration (FNA) tissues. Incorporating a modular workflow design that can expedite content expansion, this approach includes the assimilation of both DNA and RNA targets, and provides a complete targeted NGS solution for laboratories wishing to adopt NGS.
Although NGS offers advantages for sample multiplexing, high analytical sensitivity, and the ability to profile a large number of potentially clinically-actionable* biomarkers in a single test, the complexities of incorporating an NGS workflow pose a barrier for many laboratories to overcome. The Quantidex™ Pan Cancer Kit provides a streamlined wet-bench protocol and companion “push-button” analysis software that facilitates rapid training and implementation, even for laboratories with little to no NGS experience or informatics infrastructure. In addition, the product unifies pre-analytical DNA QC, sample quantification, multiplex PCR enrichment, dual-index barcoding, and library purification and quantification using reagents provided in a single kit.
On the ease of use and performance of the Pan Cancer Kit, Dr. Ximin Li, Director of the Clinical Microarray Core & Professor of Genomics at UCLA, commented, “Our evaluation demonstrated first-hand the streamlined design and workflow economy that Asuragen’s Kit offers and that is direly needed for the routine use of targeted NGS methods. We were able to generate excellent results in our first run, and process samples faster than ever before. The performance with residual clinical FFPE biopsies and multiple other controls demonstrated perfect agreement with independent analyses, and the sensitivity, specificity, accuracy, and repeatability were consistently outstanding.”
The product includes Asuragen’s Quantidex™ DNA Assay for sample quantification and qualification, which not only mitigates costly library failures and delays in the time-to-result, but also improves variant calling in tumor samples by relaying sample DNA copy number information to the bioinformatics software for analysis using a patent-pending method. Consequently, DNA inputs from FFPE and FNA tumor samples can be reduced by more than an order of magnitude compared to alternative technologies. The kit also incorporates both a synthetic multi-variant process control and an authentic FFPE control that further bolsters the confidence of mutation calling in each run.
In providing an integrated and comprehensive workflow solution, Asuragen reduces the barrier-to-entry for laboratories considering the adoption of targeted NGS oncology assays, while also providing welcomed new options for laboratories already familiar with NGS.
The development of this product was funded in part by a Cancer Prevention and Research Institute of Texas (CPRIT) Product Development Research grant.
* For Research Purposes Only. Not for use in diagnostic procedures.
About Asuragen
Asuragen is a molecular diagnostics company driving better patient management in oncology and genetic disorders through best-in-class clinical testing solutions. The company uses a breadth of technologies and scientific talent to discover, develop and commercialize diagnostic products for clinical laboratories and for our Bio/Pharma partners. Asuragen’s development of innovative diagnostic products will help transform medicine by improving clinical outcomes and health economics. For more information, visit www.asuragen.com.
