September 26, 2017 4:36 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: 69
Vice President of Human Resources
Age: 60
Vice President of Manufacturing Operations
Age: 62
Vice President of Bioservices Operations
Age: 49
Compensation as of Fiscal Year 2017.

SeraCare Life Sciences, Inc. Key Developments

SeraCare Life Sciences Announces the Launch of Suite of Zika Virus Reference Materials for Improved Diagnostic Testing

SeraCare Life Sciences, Inc. announced the launch of a set of unique Zika virus products as critical components of a robust QC program for validating and monitoring Zika virus test methods. These new innovative products provide highly characterized Zika IgM materials as well as safe to handle recombinant virus that can be used as positive reference materials for Zika diagnostic assays. A major challenge in developing and validating a Zika assay is high cross-reactivity to other flaviviruses such as dengue and chikungunya, which are present in the same geographic regions as on-going Zika infections. To overcome this challenge, SeraCare has developed the AccuSet Zika Performance Panel, which is a comprehensive 10-member panel consisting of patient samples demonstrating a range of reactivity for Zika IgM antibodies, and assessed for cross-reactivity to dengue and chikungunya. This panel is intended for use by researchers, diagnostic manufacturers, and clinical laboratories to develop, evaluate, and validate Zika serological test methods. The panel members have been comprehensively tested following the recommended CDC algorithm and using several commercially available methods. This unprecedented panel of Zika IgM materials will ensure test method validation specific to Zika IgM reactivity and rule out cross-reactivity to related flaviviruses. Molecular assays for Zika virus detection are based on PCR methodologies. However, the options available for use as positive reference materials are limited to bacteriophage, RT-DNA (plasmids), and chemically treated, cultured virus. These alternatives either do not represent the full viral genome or are potentially infectious to handle. This is a concern when working within fertility laboratories where samples are of utmost value for use in fertilization techniques.

SeraCare Life Sciences Announces cfDNA QC Technology

SeraCare Life Sciences is launching the Seraseq 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. SeraCare developed a 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 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.

SeraCare Life Sciences, Inc. Launches iQ NGS QC Management v2 Software

SeraCare Life Sciences, Inc. has announced the launch of iQ NGS QC Management v2, a software that supports whole-workflow data capture from sample preparation to variant calling, along with the associated reagent and operator data, which are all critical to building a holistic depiction of the assay's performance. To ensure the accuracy of patient testing results, clinical NGS labs must track metrics across their assay's workflow to determine whether runs were within established limits. Without software to help manage this data, labs must manually compile and trend data to determine if a run passed or failed, introducing the possibility of transcription errors and adding to the turnaround time for patient results. Additionally, during audits or inspections, labs must search and retrieve reports to demonstrate the routine assessment of run QC metrics in alignment with their quality management system.iQ NGS QC Management makes it easy for laboratories to re-create their QC workflows, set up their critical quality control metrics in the software, and have the data imported automatically using the new iQ Connector API: all to provide real time insights into performance.With the data recorded, lab managers can easily review and assess run performance, determine run pass or fail status, and identify potential sources of assay drift that may cause problems in future runs. The software then generates a Run QC Report that can be used for audits or inspections to demonstrate the run's performance in comparison to previous runs.

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