SeraCare Announces Expansion of Industry's Most Complete and Patient-Like ctDNA Reference Materials

MILFORD, MA, UNITED STATES - Apr 16, 2018 - SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, announces two new upcoming additions to the Seraseq™ Circulating Tumor DNA (ctDNA) portfolio of reference materials, ctDNA Complete™ and ctDNA Panels. These new reference materials, built with the industry's most patient-like ctDNA QC technology, expand the Seraseq product line to also cover copy number variations (CNVs) and accelerate single gene and variant-focused testing.

The use of blood-based samples to interrogate cancer diseases, i.e., liquid biopsies, continues to gain rapid importance both as a complementary tool as well as a surrogate sample for solid tissue biopsies. The Seraseq portfolio of ctDNA reference materials was developed to support and accelerate the clinical application of liquid biopsy-based cfDNA targeted NGS assays. The Seraseq ctDNA reference materials have already been shown to deliver the most patient-like reference materials that closely mimic the performance attributes of ctDNA derived from cancer patient samples.

Seraseq ctDNA Complete is an expert-curated content that adds broader coverage of all genomic events, including SNVs, INDELs, CNVs, and structural rearrangements (SVs), in molecular profiling of cancer patient specimens for disease diagnosis or therapeutic intervention. This new product offers best-in-class focused content designed for clinical NGS laboratories looking to validate and implement liquid biopsy assays for solid tumor cancer diagnosis.

The new Seraseq ctDNA Panels are disease-focused, low-plex reference samples of clinically-relevant driver mutations in oncogenes implicated in lung cancer that are routinely tested in clinical laboratories for disease diagnosis and targeted therapy selection and stratification. These include driver mutations in EGFR (T790M, L858R, exon 19 deletions, G719S), KRAS (G12D) and BRAF (V600E). These important oncogenic mutations can be assayed at a limit of detection (LOD) of 0.1% allele frequency against a background of well characterized genomic background WT cell line.

"A major challenge faced during molecular assay development is the lack of reference materials that cover a broad range of disease relevant variation while faithfully reflecting the properties of clinical specimens, such as the profile of nucleic acids fragmentation," said Dr. Brian Haynes, Associate Director of Bioinformatics at Asuragen. "The availability of multiplexed and patient-like materials such as the Seraseq ctDNA v2 reference material provides an inexhaustible resource that allows us to ask more questions in order to help develop and validate robust assays."

"With the addition of these two new products, SeraCare has expanded its industry-leading portfolio of patient-like circulating tumor DNA reference materials and now offers the most complete coverage of focused, highly-multiplexed reference samples for liquid biopsy-based molecular assays," said Trevor Brown, VP, Clinical Genomics Business Unit. "Clinical laboratories now have a selection of ctDNA reference samples for managing daily run controls of clinical disease from diagnosis, to development, validation, and standardization of NGS assays."

SeraCare will be on hand in booth #3940 at the 2018 AACR Annual Meeting in Chicago, IL, from April 14-18 to discuss the new Seraseq ctDNA Complete and ctDNA Panels, their comprehensive QC solution, and the VariantFlex platform for rapid, easy, custom reference materials that fit almost any lab's budget. There will also be featured scientific poster presentations on ctDNA, CNV, and fusion RNA QC and validation tools, including the Multi-Laboratory Assessment of a New Reference Material for Quality Assurance of Circulating Tumor DNA Measurements, to be presented by Erika Stein on April 17 at 8:00 am.

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 ensure 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).