AccuRef Diagnostics and SeraCare Announce Exclusive Partnership | ASC

AccuRef’s cancer reference materials offered through SeraCare – AccuRef to expand into companion diagnostics

MILPITAS, Calif. OCT 29, 2018 -- AccuRef Diagnostics. AccuRef Diagnostics, A Division of Applied StemCell, Inc., an ISO-certified global provider of molecular reference material for use in clinical diagnostic applications and a provider of molecular diagnostic assay development service and products, announced today an exclusive partnership with Milford, MA-based SeraCare to offer AccuRef’s broad portfolio of CRISPR-engineered cell line reference materials. AccuRef Diagnostics will continue to develop in vitro diagnostic assays for companion diagnostics applications.

Applied StemCell created the AccuRef Diagnostics division in 2017 by leveraging its CRISPR/Cas9 genome-editing technology platform to develop and commercialize the most clinically-relevant and broadest portfolio of precision engineered cell-line-based cancer reference materials targeted towards clinical genomics customers. AccuRef’s DNA and RNA reference standards help diagnostic assay developers and clinical laboratories validate and implement quality system management in a clinical workflow allowing faster assay validation and improved testing confidence.

SeraCare is a leading provider of reference materials for clinical genomics applications through their Seraseq® brand of highly-multiplexed DNA and RNA reference standards for whole genome and targeted whole exon NGS sequencing applications.

The AccuRef-brand compliments the Seraseq® brand by enabling low-to-mid plex clinical genomic applications such as qPCR, digital PCR (dPCR), Sanger, mass spec, and small targeted NGS sequencing gene panels. AccuRef Diagnostics will also provide SeraCare access to custom CRISPR-engineered cell-lines services and custom blended derivative cell line products. Starting in January 2019, customers will be able to purchase AccuRef cancer reference materials directly from SeraCare globally with the exception of China (including HK and Taiwan). As a result of the SeraCare partnership, AccuRef Diagnostics will reemphasize its commercial efforts towards in vitro diagnostic assay development with focus on biopharma customers and also by developing a completely integrated diagnostic system solutions to enable novel biomarker testing. “AccuRef has worked very hard to develop a robust quality system and obtain our ISO 13485 certification. Combined with our broad portfolio of highly sensitive, specific, and robust internally-developed in vitro diagnostic digital PCR and NGS assays used for internal quality control testing of our reference products, has allows us to leveraging our assay development expertise to nurture companion diagnostic assay development partnerships with key pharma customers which will hope to take through FDA approval as diagnostic partners.”, said Dr. Ruhong Jiang, CEO of Applied StemCell, Inc.

About AccuRef Diagnostics, A Division of Applied StemCell, Inc. AccuRef Diagnostics is the companion diagnostics assay development and reference material division of Applied StemCell, Inc. Applied StemCell, Inc. is a leading genome editing company focused on providing enabling toils for drug discovery and developing a portfolio of curative gene therapy products. Our custom genome editing services supports basic research, drug discovery, bio-processing, bio-spanning, and preclinical applications, which are enabled by our proprietary and licensed genome editing platforms, TARGATT™ and CRISPR/Cas9, respectively.

About SeraCare Life Sciences, Inc. SeraCare enables the promise of precision medicine by advancing the understanding of disease and providing assurance of the diagnostic result. Our innovative tools and technologies not only provide assurance of the safe, effective, and accurate performance of diagnostic assays but also establish a framework for regulating, compiling, and interpreting data from precision diagnostics. Our portfolio includes a broad range of products such as quality control technologies, disease-state specimens, and tissues for research and development, processed biological materials, and immunoassay reagents.

Contact: Gianluca Roma

Director of Marketing and Business Development AccuRef Diagnostics 408-753-5716

gianluca.roma@accuref.com