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    Trusted partner and worldwide supplier to the diagnostic testing industry for over 30 years

    Advancing the development of molecular and serology diagnostics with innovative technology, quality controls, reagents, and biological materials

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Find your tools for precision diagnostics

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Clinical Genomics

Next-gen sequencing tools and reference materials to support emerging precision medicine diagnostics

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Clinical Laboratories

Quality controls and validation materials to monitor the performance of diagnostic assays

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Assay Developers

Biological materials and reagents to develop and manufacture test kits for precision diagnostics

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Life Science Researchers

Antibodies and immunoassay reagents for research and commercial assay development

Clinical genomics diagnostics

With novel QC technology and biosynthetic reference materials for clinical genomics diagnostics, SeraCare provides confidence in test results for oncology, non-invasive prenatal testing, and infectious disease.

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Collaboration and Partnerships

Join our team of early-access users to sample and evaluate new products as they emerge from our development pipeline. Partner with us and provide industry feedback to help shape and optimize QC products for the future.

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Over 30 years of experience

SeraCare is a trusted partner to the diagnostic testing industry. For over 30 years, we have evolved with technology to support the advancement of life science research, IVD development, and clinical laboratory testing.

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What people are saying

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The interlaboratory comparisons made possible by this partnership [NIST and SeraCare] will speed NIST's efforts to overcome measurement challenges and advance cancer-detection technology broadly for the biomedical community. Studies have shown that circulating tumor DNA can be detected in many cancers and it can be used to monitor therapeutic progress. - Kenneth Cole, a group leader in NIST's Biosystems and Biomaterials Division
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Seraseq reference materials offer a comprehensive and customizable set of mutations which are ideally suited to the comprehensive nature of the TOMA OS-Seq reagent kit. More importantly, we share the vision of a strong quality and regulatory approach when bringing validated NGS-based tumor profiling assays to market. - Federico Goodsaid, Ph.D., Vice President of Assay Development and Regulatory Affairs
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Understanding and characterizing any NGS assay for liquid biopsy samples will require well-defined reference reagents. Standards like Seraseq ctDNA reference material allow the community to first understand ctDNA properties, optimize assays and then ultimately use ctDNA in innovative assays to detect and monitor cancer burdens within samples. In turn, this type of work will lay the foundation for transforming future cancer treatments. - Dr. Timothy Harkins, CEO of Swift Biosciences
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It's really nice to work with SeraCare these years. I want to say thank you so much for all the efforts since we began working together. SeraCare has done an excellent job in supporting our business and I know that you will continue to do so in the future. I am always impressed with SeraCare's professionalism, passion, innovation, and attention to detail. Thank you again for everything!

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  • https://blog.seracare.com/hubfs/iStock_Purchased_Images/iStock-474360451-461242-edited.jpg?t=1508332933873

    This is the Number One Risk to Your Clinical Sequencing Assay

    If youre relying on remnant patient samples to tell you how well your lab's bioinformatics pipeline can call clinically important variants, you might be missing more than you realize.

    In our experience, the bioinformatics pipeline can be the weakest link in assay development for many labs. Just because a variant is sequenced correctly doesnt always mean that it will be called. And false-positives are just as bad.

    • Sometimes its an issue of allele frequency. For example, weve seen cases where labs could detect certain mutations at 10% allele frequency, but as soon as the frequency dropped to 7%, they stopped detecting it.
    • Other cases are caused by the complexity of the variant. For example, even at low allele frequencies, a lab may pick up relatively easy-to-detect single-nucleotide variants (SNVs) but can have problems with insertion/deletion (INDEL) calling errors.

    In both examples, the mutations arent missed because of sequencing or library preparation problems. As weve witnessed time and time again, when labs optimize their bioinformatics pipelines, they start picking up the low-frequency and difficult-to-detect variants again.

    The catch is, you first have to know youre missing something. In assay development, what you dont know can seriously weaken your test.

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