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MILFORD, MA - Jul 18, 2017 - SeraCare Life Sciences , a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, is launching the SeraseqTM Circulating Tumor DNA v2 reference materials : a breakthrough in circulating cell-free DNA QC technology that will help ensure sensitivity and robustness of liquid biopsy assays. The Seraseq circulating tumor (ctDNA) reference materials were produced using innovative technology developed at SeraCare to fulfill the critical need for reference materials that closely mimic the performance attributes of ctDNA derived from clinical specimens. 

Liquid biopsy, the non-invasive analysis of ctDNA, is poised to revolutionize cancer diagnostics and treatment. However, a major challenge for those developing and validating these assays is ensuring detection of rare pathogenic variants at very low allele frequencies. The advances in liquid biopsy technology have outpaced improvements in accompanying circulating cell-free DNA (cfDNA) QC materials and methods. Until now, the only options available have been remnant patient specimens or ultrasonicated cell lines. Unfortunately, remnant samples are notoriously difficult to source and are relatively poorly characterized. Ultrasonicated cell lines do not match native cfDNA in terms of size distribution and condition of the DNA, which leads to poor target enrichment, low library yield and complexity, and reduction in sensitivity for many assays.

In order to overcome these challenges, SeraCare developed a unique patent-pending technology that produces a DNA fragment size-distribution which closely mimics native cfDNA, while decreasing DNA damage relative to ultrasonicated material. The result is a renewable source of highly characterized material that exhibits similar performance when treated identically to a patient sample. Unlike ultrasonicated materials, for which increased DNA input amount or sequencing depth must be used to obtain similar performance, the Seraseq ctDNA v2 requires no special workflow considerations to generate informative data. This is especially important for validation studies that require strict adherence to standard operating procedures.

This unique product contains 40 somatic mutations , including the most important alterations for ctDNA analysis such as BRAF V600E, KRAS G12D, and EGFR T790M and an EGFR exon 19 deletion. Variants are present against a single well-characterized genomic background across a range of allele frequencies down to 0.125%, which ensures utility for assays with different limits of detection.

“One of the biggest challenges in developing highly sensitive ctDNA assays is the lack of reference materials that perform like real-world samples and contain all of the relevant variants. Seraseq ctDNA reference materials resemble native cfDNA, from pre-analytic assessment of DNA quality through sequencing. We expect these new references will greatly facilitate our assay development, and they also potentially will help our customers execute an effective QC strategy,” said Dr. Jason Myers, CEO at ArcherDX. “Our longstanding relationship with SeraCare continues to result in products that fit previously unmet needs for next-generation liquid biopsy analysis.”

“As an industry leader for clinical genomics reference materials, we have spent significant time with subject experts to thoroughly understand the challenges ctDNA technologies face, and what is needed to effectively accelerate assay development and adoption in the clinic,” said Russell Garlick, Ph.D., Chief Scientific Officer at SeraCare. “In response, we have developed a ground-breaking technology to produce highly functional, ctDNA-like materials, or truth sets, that will enable the industry to develop, optimize, and implement more accurate and robust assays. Our innovative Seraseq ctDNA reference materials can finally provide the assurances in variant composition and performance that labs are looking for, which have so far been elusive using existing methodologies and materials.”

Learn more about the patient-like characteristics of Seraseq ctDNA v2 reference materials at https://www.seracare.com/ctDNA .

For data and in-depth technical information read this technical report: digital.seracare.com/ctDNA .

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 ).