MILFORD, Mass., Feb 13, 2018 /PRNewswire/ -- 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 Breast CNV and Seraseqâ„¢ Lung and Brain CNV
Mix. Reference materials that analyze for CNVs allow for a
complete and comprehensive variant assessment of DNA-based tumor
profiling and diagnostic molecular assays beyond SNVs and indels.
These expert-designed products are built with innovative
biosynthetic technology that is easily scalable to incorporate new
CNVs over time.
Copy number variations (CNVs) are DNA segments present at a
variable copy number in comparison to a normal genome. Cells that
are affected by aberrant copy number changes for certain
cancer-associated genes may experience disruption of normal
cellular function and, ultimately, tumorigenesis. Next-generation
sequencing (NGS) can be used to determine CNVs across multiple
genes in a sequencing run.
In order to help clinical labs performing NGS-based tumor
profiling for cancer diseases thoroughly understand and
characterize their assays, SeraCare has developed the first set of
dedicated CNV reference materials for NGS assays - Seraseq Breast
CNV Mix and Seraseq Lung and Brain CNV Mix. These unique products
were precisely quantified using highly sensitive digital PCR assays
to analyze amplifications of EGFR, MET, FGFR3, MYC, ERBB2, and MYCN
genes at +3, +6, and +12 copies against a single well-characterized
genomic background (GM24385).
"The lack of realistic reference materials representing a broad
range of cancer somatic aberrations has been a challenge for
test developers and clinical labs alike when it comes to measuring
accuracy of NGS tumor profiling tests " said Anna V.
Hartwig, PhD, VP of R&D, TOMA Biosciences.
"SeraCare reference materials have already enabled us to benchmark
the ability of our assay to identify SNVs, indels, and
rearrangements. Now with the new Seraseq CNV reference
materials for detecting and quantifying oncogenic amplifications
typical of breast, lung, and brain cancers, we have
a complete tool set for the analytical validation of labs using our
assay. This tool set is a great asset in advancing the
ultimate end-goal of driving accurate diagnosis and management of
treatment options available to cancer patients."
"With the release of the industry's first quantitative
CNV-focused reference materials for tumor profiling, we continue
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, heme
malignancies, 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 for the Clinical Genomics Business Unit at
SeraCare.
SeraCare will be on-hand in Booth #406 at the 2018 Tri-Con
Meeting in San Francisco, CA, from
February 12-16 to discuss the new
Seraseq Breast CNV and Seraseq Lung & Brain CNV reference
materials, their complete QC solution, and the VariantFlex platform
for rapid, easy, custom reference materials that fit almost any
lab's budget. There will also be an industry-sponsored symposium on
ctDNA reference materials in the development and validation of
liquid biopsy NGS assays, to be presented by Dr. Brian Haynes, Associate Director of
Bioinformatics, Asuragen, Inc., on February
15 at 10:00 am.
Learn more about the Seraseq CNV reference materials at
https://www.seracare.com/cnvs.
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).
Company Contact:
Heather
DelCarpini
SeraCare Life Sciences, Inc.
508.244.6429
hdelcarpini@seracare.com
www.seracare.com
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SOURCE SeraCare Life Sciences