Grant will support commercialization of SuraSeq, Asuragen’s FFPE and FNA NGS cancer mutation panels.

The Cancer Prevention and Research Institute of Texas (CPRIT) is awarding Asuragen a $6.8 million commercialization award to pursue next-generation sequencing (NGS) applications. Acceptance of the award is subject to the completion of due diligence and contract negotiations.

Asuragen points out that its NGS programs have targeted high-value and clinically actionable mutation profiling, the discovery of cancer-linked genomic variants, and confirmatory testing with orthogonal NGS platforms. Proceeds from the CPRIT award will help enable Asuragen to expand its SuraSeq™ NGS product line, uncover both known and novel clinically relevant variants, and develop reliable confirmatory methods with associated clinical utility.

“NGS has generated excitement in life sciences and healthcare by facilitating the rapid and cost-effective determination of large volumes of sequence information,” says Matt Winkler, Ph.D., the founder and CEO of Asuragen. “Our development work at Asuragen has demonstrated that it is possible to analyze and interpret cancer profiles from minimal tumor biopsies at a depth and sensitivity that may address gaps in clinical cancer research and, ultimately, cancer patient management. The CPRIT grant provides significant support to further develop and ultimately commercialize NGS-based tests in our CLIA laboratory.”

As part of the grant, Asuragen is collaborating with Heidi Erickson, Ph.D., Ignacio Wistuba, M.D., Vassiliki Papadimitrakopoulou, M.D., J. Jack Lee, Ph.D., and Gordon Mills, M.D., Ph.D. at MD Anderson Cancer Center to apply Asuragen’s targeted NGS strategy to patient tumors in the context of pathway-based systems biology analyses. They will then match the data to targeted therapies and subsequent outcomes. Asuragen will test specimens from the BATTLE-2 Program, which is an innovative biomarker-integrated targeted therapy study and one of the first biopsy-driven prospective personalized medicine clinical trials. The BATTLE-2 Program will provide the opportunity to test the integration of routine pathology processing of NSCLC FNA specimens with the proposed NGS analysis in a clinically actionable trial environment that pairs cancer drugs to individualized patient biomarker profiles.

“While the early application of NGS has focused on a variety of model organisms and basic research projects, it is widely anticipated that as the technologies become more robust and the time and cost for sequencing are reduced, NGS will enable the ultimate realization of personalized medicine,” says Gordon Mills, co-director of the Institute for Personalized Cancer Therapy at the University of Texas MD Anderson. “The NGS products Asuragen is developing have the potential to reduce overall healthcare costs and enhance the care of cancer patients.”

Asuragen’s product portfolio consists of the first-ever validated miRNA diagnostic test for pancreatic cancer, multiplex quantitative RNA-based assays, solutions for the detection of the fragile X mental retardation gene, Signature® Oncology products for the qualitative detection of gene translocations and mutations, an FDA-approved RNA tissue stabilization solution based upon RNAlater® technology, and industry-leading controls and standards engineered using its patented Armored RNA® technology. In addition, Asuragen offers a full range of contract manufacturing services for high-quality QSR compliant reagents from plasmid DNA to in vitro synthesized RNA and complex assays for IVD cleared platforms.

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