February 25, 2017 1:56 AM ET

Life Sciences Tools and Services

Company Overview of SeraCare Life Sciences, Inc.

Company Overview

SeraCare Life Sciences, Inc. provides products and services to facilitate the discovery, development, and production of human and animal diagnostics, and therapeutics. The company’s Diagnostic and Biopharmaceutical Products segment offers controls and panels for the evaluation and quality control of infectious disease tests in clinical laboratories, blood banks, and in vitro diagnostic (IVD) manufacturing; and reagents and bioprocessing products for use in the discovery, development and manufacturing processes for drugs, vaccines, and diagnostic tests. It also provides diagnostic intermediates for use in manufacturing diagnostic test kits; cell culture additives and media that maintain viabi...

37 Birch Street

Milford, MA 01757

United States

Founded in 1984

193 Employees

Phone:

508-244-6400

Fax:

508-634-3394

Key Executives for SeraCare Life Sciences, Inc.

Chief Executive Officer and President
Chief Financial Officer and Secretary
Age: 68
Vice President of Human Resources
Age: 59
Controller
Vice President of Manufacturing Operations
Age: 61
Compensation as of Fiscal Year 2016.

SeraCare Life Sciences, Inc. Key Developments

SeraCare Introduces Two New Seraseq Reference Materials for Clinical Oncology Assays

SeraCare Life Sciences has introduced two new reference materials for genomic analysis of solid tumours at the Association for Molecular Pathology 2016 annual meeting in Charlotte, North Carolina. The Seraseq Tumor Mutation DNA Mix v2 (RUO-GMP) and Seraseq FFPE Tumor KRAS Reference Material Kit are claimed to be accurate, precise and consistent materials and can help laboratories in determining the performance of their clinical oncology assays. SeraCare says that detecting cancer-relevant mutations with the help of technologies such as NGS or qPCR can be challenging for various reasons. The presence of variant at allele frequencies approaching lower limit of detection (LoD), variation that affects results can be difficult to trace and often arises across complex workflows. Assays can have different levels of sensitivities across different types of mutations. Along with this, using residual patient samples or cell lines that are positive for single mutation as reference materials may not be cost effective for highly multiplexed assays which can detect many biomarkers in a single run. According to SeraCare, the Seraseq Tumor Mutation DNA Mix v2 has 40 clinically actionable and analytically challenging mutations at 10%, 7% and 4% Minor Allele Frequency (MAF). The company says that it has been produced with good manufacturing practices (GMP) to ensure consistency between lots. The multiplexed material contains challenging and relevant variant types in a reference material on the market, which includes structural variants with defined intronic breakpoints, insertion/deletion mutations and variants present in repetitive sequence contexts. It is available in a Tri-Level format, where the 40 mutations are distributed across three MAFs, in a single vial. On the other hand, the Seraseq FFPE Tumor KRAS Reference Material Kit v1 has 7 mutations affecting codons 12 and 13 of the KRAS gene, which account for about 97% of all characterized KRAS mutation subtypes. All the variants are present at about 5% MAF in order to rigorously challenge the LoD for common and commercially available KRAS tests.

SeraCare Life Sciences Signs an Agreement with Laboratoire Cerba to Provide Custom Seraseq Aneuploidy Reference Materials

SeraCare Life Sciences has signed an agreement with Laboratoire CERBA to provide custom Seraseq (TM) Aneuploidy Reference Materials for use with Laboratoire CERBA's non-invasive prenatal testing (NIPT) assay. NIPT is the analysis of cell-free DNA (cfDNA) from maternal blood to screen for common trisomies, primarily by next-generation sequencing (NGS). With higher detection rates than traditional first trimester screening, it is rapidly becoming the preferred screening method and continues to expand globally, especially in average-risk populations. There is, however, a critical and urgent need for high quality and widely distributed reference materials that mimic authentic cfDNA characteristics and offer patient-like commutability to ensure assay accuracy, consistency, and reliability. Under the terms of the agreement, SeraCare will provide Laboratoire CERBA with Seraseq Aneuploidy reference material at specified fetal fraction levels to support validation and daily run performance monitoring of NGS-based trisomy 13, 18, and 21 screening assays across the entire workflow from extraction through sequencing and data analysis.

SeraCare Life Sciences and National Institute of Standards and Technology Partner on Development of Circulating Tumor DNA Reference Standards for Diagnostics

SeraCare Life Sciences and the U.S. Department of Commerce's National Institute of Standards and Technology (NIST) have signed a three-year Cooperative Research And Development Agreement (CRADA) to advance the development of circulating tumor DNA (ctDNA) diagnostic assay reference standard materials. Detection of cell-free circulating tumor DNA is a promising method with the potential to diagnose, profile, and monitor cancer, and there is an acute need for standards to compare the detection limits of diagnostic assay development. Under the terms of the agreement, SeraCare will provide their Seraseq ctDNA Reference Material technology to NIST for development of digital PCR measurement methodologies, and NIST will facilitate a wider distribution of these materials to anonymized laboratories for inter-laboratory comparisons. The joint efforts are meant to hasten the development of calibrated reference standards for circulating tumor DNA critical for expanding the use of these technologies into the translational research and diagnostic labs.

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