SeraCare Announces Industry's First Comprehensive NGS Reference Material for Hematologic Malignancies

MILFORD, MA, UNITED STATES - Nov 8, 2017 -  SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, is expanding what is already the most comprehensive suite of clinical genomics development, validation, and QC tools with the launch of the SeraseqTM Myeloid DNA and Myeloid RNA fusion reference materials: the industry's first comprehensive reference standards to help ensure the sensitivity and robustness of next-generation sequencing (NGS) based assays focused on myeloid cancers. These expert-designed products are built with the same innovative biosynthetic technology that powers SeraCare's patient-like NGS reference materials for tumor profiling and inherited disease testing.

Blood cancers, such as acute myeloid leukemia (AML) and chronic myeloid leukemia (CML), are estimated to affect millions of people around the world, but current diagnosis methods are time-consuming and expensive. Molecular analysis of myeloid cancers is rapidly shifting from traditional singleplex methods such as FISH and qPCR, to highly multiplexed NGS assays. To ensure confidence in assay performance across the diverse types of mutations prevalent for myeloid cancers, clinical labs need to overcome the challenge of sourcing relevant mutations and the high expense associated with singleplex samples such as residual patient specimens and cell lines.

To help clinical labs performing NGS-based myeloid testing thoroughly understand and characterize their assays, SeraCare has developed the Seraseq Myeloid Mutation DNA Mix and Seraseq Myeloid Fusion RNA Mix, the first set of comprehensive myeloid cancer NGS reference materials. These unique products include a wide range of mutation types, from simple but clinically important SNVs, to gene fusions. To maximize compatibility with existing and emerging myeloid assays, the new products contain 23 DNA mutations (including FLT3 ITDs and NPM1) along with nine fusion RNAs (including BCR-ABL and PML-RARA). Variants are present against a single well-characterized genomic background (GM24385) at clinically relevant allele frequencies which are precisely quantified using highly sensitive digital PCR assays.

"As laboratorians develop and validate assays for hematologic malignancies, it is critical that they establish and demonstrate the true analytical performance characteristics of these assays.  However, the lack of readily available materials that cover a wide range of meaningful variants at relevant allele frequencies, for both DNA and RNA, make this challenging," said Bob Daber, PhD and founder of Gnosity Consults, LLC, who contributed to the design of the product. "The Seraseq myeloid NGS reference materials will greatly expedite the validation of these assays to ensure they are up and running quickly while also being confident in their ability to detect the challenging mutations, with the ultimate end-goal of driving accurate diagnosis and effective patient management."

"With the release of the industry's first comprehensive NGS reference materials for myeloid cancers, we expand our commitment and leadership in the clinical genomics market.  SeraCare now offers the industry's widest portfolio of clinical genomics QC reference materials and software for applications that include tumor profiling, liquid biopsy, inherited disease testing, and NIPT. Our innovative products developed with ground-breaking technology and partnerships with key industry experts are now significantly accelerating new assay development and validation, along with providing confidence in the accuracy of routine assay results, in a wide range of laboratories worldwide," said Trevor Brown, VP of the Clinical Genomics Business Unit at SeraCare.

SeraCare will be on-hand in booth 811 at the AMP Annual Meeting in Salt Lake City, Utah from November 16-18 to discuss the new Seraseq myeloid reference materials, their complete QC solution, and the VariantFlex platform for rapid, easy, custom reference materials that fit almost any lab's budget. They will be presenting a practical guide of best practices for quick but affordable NGS validations in their corporate workshop on November 15th at 8:00 am entitled "Validate Your Clinical Genomics Assay Without Crushing Your Budget or Sanity." Learn more at digital.seracare.com/amp-2017.

Learn more about the Seraseq Myeloid reference materials at www.seracare.com/myeloid.

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. For more information, please visit www.seracare.com and follow SeraCare on Twitter (@SeraCare).