SeraCare Life Sciences, Inc. of Milford, MA at MEDICA 2017 in Düsseldorf -- COMPAMED Trade Fair

SeraCare Life Sciences, Inc.

37 Birch Street, 01757 Milford, MA
United States of America

Telephone +1 508 244-6400
Fax +1 508 634-2224
info@seracare.com

Hall map

MEDICA 2017 hall map (Hall 3): stand E45

Fairground map

MEDICA 2017 fairground map: Hall 3

Our products

Product category: Tumor markers

Seraseq™ FFPE Tumor Fusion RNA Reference Material v2

As the diagnostic testing paradigm for chromosomal translocations and other complex structural variants continues to shift from single-site Fluorescent In Situ Hybridization (FISH) and targeted RT-PCR to highly multiplexed Next Generation Sequencing (NGS) assays, there is increasing need for highly multiplexed reference materials for these difficult mutations.  Seraseq FFPE Tumor Fusion RNA Reference Material v2 contains 16 clinically significant RNA fusions which are prevalent across different types of solid tumors, in an efficient single-sample format.

RNA transcripts carrying structural variants are engineered into well-characterized, “wild-type” cells.  Cells are formalin-fixed and embedded in paraffin, and the FFPE block is cut into 10-micron sections, each of which typically yields at least 400 nanograms of RNA.  The transcript level for each fusion is quantified using highly sensitive digital PCR to establish “ground-truth”, which helps ensure the material remains constant over time.

  • 16 clinically relevant fusions evaluate assay sensitivity and specificity for important diagnostic, prognostic, and therapeutic targets (see table below)
  • Multiplexing of mutations saves time and cost by generating the most information in a single run
  • Full-process FFPE format may be treated like a clinical specimen, which can reveal pre-analytic variability
  • Quantification of transcript levels by digital PCR establishes “ground-truth” and simplifies dilutions for Limit of Detection (LoD) experiments
  • Total RNA from well-characterized GM24385 cell line as background “wild-type” material
  • Manufactured in GMP-compliant and ISO 13485-certified facilities

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Product category: Tumor markers

Seraseq™ Tumor Mutation DNA Mix v2 AF10 LC

The Seraseq Tumor Mutation DNA Mix v2 (AF10) LC is a multiplexed mixture of actionable biosynthetic DNA targets precisely blended with a single, well-characterized genomic background to an allelic frequency of 10%, offered in a low concentration (LC) at 5 ng/μL for assays that have lower input DNA requirements. Designed to assess the overall performance of your somatic mutation assay by next-generation sequencing (NGS), this unique product includes a wide range of single nucleotide variants (SNVs), insertion-deletion mutations (indels), and structural variants (SVs).

  • Single-vial format for daily run use
  • 40 unique multiplexed variants across 28 genes (see table on right)
  1. 20 SNVs
  2. 5 SNVs that are part of homopolymers
  3. 13 indels
  4. 2 SVs 
  • Mutation targets quantitated with digital PCR
  • Well-characterized GM24385 human genomic DNA as background ‘wild-type’ material
  • Manufactured in cGMP compliant, ISO 9001 and ISO 13485 certified facilities
For for a detailed list of variants click here.

The Seraseq Tumor Mutation DNA Mix v2 (AF10) LC is formulated for use with targeted next-generation sequencing (NGS) assays that detect mutations in key oncogenes and tumor suppressor genes. The Seraseq Tumor Mutation DNA Mix v2 (AF10) LC is intended as a quality reference material for translational and disease research testing to monitor library preparation, sequencing, and variant allele detection under a given set of bioinformatics pipeline parameters.

For research use only. Not for use in diagnostic procedures.

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Product category: Tumor markers

Seraseq™ ctDNA Mutation Mix v2 AF2%

To overcome the lack of patient-like reference materials for liquid biopsy, including drawbacks of existing methodologies such as sonication, SeraCare has developed a breakthrough technology that produces the most patient-like materials compared to native ctDNA.  The Seraseq ctDNA Mutation Mix v2 is a highly multiplexed product for NGS-based ctDNA assays targeting cancer-relevant somatic mutations.

  • Size distribution, library yield and complexity consistent with native ctDNA
  • Single sample with 40 clinically-relevant mutations across 23 genes,  all at the same specified allele frequency
  • Offered as a purified DNA mixture for ease of use during assay development
  • Mutation targets precisely quantitated with digital PCR
  • Single well-characterized GM24385 human genomic DNA as background ‘wild-type’ material
  • Manufactured in GMP-compliant and ISO 13485-certified facilities 
# of variants:                       40 (To see the full list of variants, click here.)

Allele Frequency:                1%

Fragment size:                     170bp average

Concentration:                     10 ng/µL               

Amount:                               250 ng (single vial)

Buffer:                                  1 mM Tris / 0.1 mM EDTA pH 8.0

Find more data and in-depth technical information by reading this technical report.

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Product category: Tumor markers

Seraseq™ ctDNA Reference Material v2 AF0.25%

To overcome the lack of patient-like reference materials for liquid biopsy, including drawbacks of existing methodologies such as sonication, SeraCare has developed a breakthrough technology that produces the most patient-like materials compared to native ctDNA.  The Seraseq ctDNA Reference Material v2 is a highly multiplexed product for NGS-based ctDNA assays targeting cancer-relevant somatic mutations. 

  • Size distribution, library yield and complexity consistent with native ctDNA
  • Single sample with 40 clinically-relevant mutations across 23 genes,  all at the same specified allele frequency
  • Offered in a full-process plasma-like material capable of assessing the entire workflow from extraction through analysis
  • Mutation targets precisely quantitated with digital PCR
  • Single well-characterized GM24385 human genomic DNA as background ‘wild-type’ material
  • Manufactured in GMP-compliant and ISO 13485-certified facilities
# of variants:                       40 (To see the full list of variants, click here.)

Allele Frequency:                0.25%

Fragment size:                     170bp average (and encapsulated)

Concentration:                     25 ng/mL              

Amount:                               125 ng (single vial)

Matrix:                                  SeraCon™ Matribase (human plasma-like matrix)

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Product category: Tumor markers

Seraseq™ Tumor Mutation DNA Mix v2 AF4 HC

The Seraseq Tumor Mutation DNA Mix v2 (AF4) HC is a multiplexed mixture of actionable biosynthetic DNA targets precisely blended with a single, well-characterized genomic background. This product is produced under rigorous design control and manufacturing practices to an allelic frequency of 4%, and is offered in a high concentration (HC) format at 25 ng/μL. Designed to assess the overall performance of your somatic mutation assay by next-generation sequencing (NGS), this unique product includes a wide range of single nucleotide variants (SNVs), insertion-deletion mutations (indels), and structural variants (SVs).

  • Single-vial format for daily run use
  • 40 unique multiplexed variants across 28 genes (see table on right)
  1. 20 SNVs
  2. 5 SNVs that are part of homopolymers
  3. 13 indels
  4. 2 SVs 
  • Mutation targets quantitated with digital PCR
  • Well-characterized GM24385 human genomic DNA as background ‘wild-type’ material
  • Manufactured under cGMP within ISO 9001 and ISO 13485 certified facilities

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About us

Company details

Trusted partner to the diagnostic testing industry 
Developing innovative products to support emerging test methods. 

SeraCare is a leading partner and supplier of diagnostic quality controls, biological materials, and reagents to in vitro diagnostics developers, clinical laboratories, and life science researchers worldwide. Since the early 1980's, we have supported the diagnostic testing industry with biological materials to develop, validate and challenge today's most trusted serology and molecular infectious disease assays. With the evolution of testing and the growing needs of our clients, we have expanded our business to support precision medicine diagnostics and advanced diagnostic applications such as next-generation sequencing and digital PCR.  

Passion. Innovation. Precision. 
Enabling the promise of precision medicine through precision diagnostics.

SeraCare provides innovative technologies that leverage our deep experience and unique perspective to enable the promise of precision medicine. This is a result of our unwavering commitment to serve and empower clinical and research laboratories, as well as in vitro diagnostics developers. The precision diagnostics materials we develop establish a framework for compiling, interpreting and regulating the influx of new genetic information. These critical technologies bridge the gap between today’s diagnostic solutions and tomorrow’s emerging tools for molecular diagnostics and next-generation sequencing.

SeraCare is as passionate about ending the mystery and misery of disease as the dedicated scientists we serve. That is why we provide the same rigor, accuracy and thoroughness in our solutions as these quiet heroes do in their research.

Everyone at SeraCare takes personalized medicine very personally. We’re committed to being on the forefront of this amazing era.

Delivering on the promise of precision medicine. 
An unwavering commitment to the betterment of humanity. 

Our Vision
A world where the underlying molecular drivers of disease are understood and ultimately addressed.

Our Mission
To support scientists and clinicians in bringing the promise of precision medicine to humanity by providing the technologies that establish a framework for regulating, compiling and interpreting precision diagnostic results.

Our Focus
Creating solutions that bring precision to precision medicine.

Our Passion
Helping scientists and doctors help humanity.

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