Detecting the Undetectable: Development & Validation of Ultrasensitive Simoa-based Immunoassay Services

Pharmaceutical Regulation, Pharmaceutical, Drug Safety, Laboratory Technology,
  • Tuesday, August 25, 2015

Reliably detecting immuno-modulating proteins in serum and plasma from normal individuals has historically been impossible due to the lack of sensitivity of conventional immunoassays. Quanterix and Myriad RBM are working together to change this paradigm via ultrasensitive, high quality immunoassay services that offer drug developers an unparalleled approach to clinical research.

Quanterix, the developer of single molecule arrays (Simoa) technology, will describe the use of Simoa for the detection of proteins at very low concentrations, capable of providing a 1000-fold improvement in sensitivity to proteins over conventional assays. We will review the scientific principles that allow counting individual protein molecules and we will demonstrate how the Simoa technology can be used to obtain remarkable improvements in sensitivity, which has enabled significant breakthroughs in several therapy areas.

Myriad RBM, a leader in immunoassay testing services, will describe validated Simoa-based assay services and how carefully designed calibrators and controls ensure quality, precision and accuracy. Examples of how these reproducible assays, offered as a service in Myriad RBM’s CLIA certified lab, can measure proteins at the femtogram per mL level will be demonstrated by quantifying key immune modulating proteins, present at undetectable levels with conventional technology in serum and plasma, from normal and diseased subjects. In conclusion, we will show that the unprecedented sensitivity and reliability of these ultrasensitive immunoassay services have the potential to revolutionize clinical research in multiple therapeutic areas including immuno-oncology, autoimmune disorders, cardiovascular diseases and other research focusing on inflammatory processes.


James P. Mapes, Ph.D., Chief Scientific Officer, Myriad RBM

Dr. Mapes brings more than 15 years of experience in the development and commercialization of diagnostic assay kits to Myriad RBM. Before joining Myriad RBM, Dr. Mapes was Director of Research and Development for Luminex Corporation. Prior to Luminex, he worked for Becton Dickinson as Director of Clinical Affairs, where he was responsible for biological and clinical evaluation of new products. Previously, he was with Bayer Diagnostics, EnSys Corporation and Becton Dickinson with increasing responsibilities in research and development management. After post-doctoral training at Oxford University, Oxford, England, and Texas A&M University, he held a faculty position in the Biochemistry Department at Louisiana State University Medical Center in New Orleans. Dr. Mapes received his Ph.D. in Biochemistry at Indiana University in 1975.

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Mark Roskey, VP/GM, Applications and Reagents, Quanterix

Mark Roskey joined Quanterix in mid 2014 as the Vice President and General Manager of Applications and Reagents. Mark comes to Quanterix from PerkinElmer’s LST division where he was VP/GM of the America’s Sales and Service organization. Prior to PerkinElmer, Mark held senior level commercial and technical positions at Caliper Life Sciences which was acquired by PerkinElmer in 2011. Mark has more than 25 years of experience in the life science industry focusing on product R&D, applications development, strategic sales and marketing, and overall business management for complex biological solutions and automated instrument systems. Dr. Roskey has a Ph.D. in Microbiology from the University of Notre Dame and completed a postdoctoral fellowship in Molecular Immunobiology at the Harvard Medical School.

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Who Should Attend?

Investigators interested in incorporating protein biomarkers in drug development, especially in immuno-oncology, autoimmune disorders, cardiovascular diseases and other research areas focusing on inflammatory processes

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Myriad RBM

Myriad RBM, Inc. is the world’s leading multiplexed immunoassay testing laboratory, providing comprehensive protein biomarker services based on its Multi-Analyte Profiling (MAP) technology platform. This platform provides pre-clinical and clinical researchers with reproducible and quantitative data for a few or hundreds of proteins in a cost-effective manner. All services are performed in our CLIA certified laboratory. As a guide to drug development researchers, Myriad RBM also offers companion diagnostic, custom assay development, co-sponsored research programs, and innovative cell culture products and services.

Myriad RBM’s CLIA certified biomarker testing laboratory is located in Austin, TX. Myriad RBM is a wholly owned subsidiary of Myriad Genetics, Inc. (MYGN), a leading molecular diagnostic company based in Salt Lake City, Utah which develops and markets novel predictive medicine, personalized medicine and prognostic medicine tests.


Founded in 2007, Quanterix has developed an ultra-sensitive diagnostic platform capable of measuring individual proteins at concentrations 1000 times lower than the best immunoassays available today.

The Single Molecule Array (Simoa™) technology at the heart of the platform enables the detection and quantification of biomarkers previously difficult or impossible to measure, opening up new applications to address significant commercial unmet needs in life science research, in-vitro diagnostics, companion diagnostics, blood screening, and more. Quanterix is a venture capital backed company and the exclusive licensee of a broad intellectual property portfolio initially developed at Tufts University by Dr. David Walt, scientific founder of Quanterix and Illumina (NASDAQ: ILMN).

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