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Thermo Fisher Scientific and Intrinsic Bioprobes Collaborate to Develop MS Immunoassay Workflow

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Thermo Fisher Scientific Inc. and Intrinsic Bioprobes (IBI) Inc., have announced an alliance to co-develop and market a mass spectrometry solution that will enable researchers to perform quantitative, high-throughput, high-resolution protein biomarker assays.

The solution couples the specificity of immunoenrichment with the sensitivity and quantitative capability of mass spectrometry to provide researchers with a complete, higher-resolution view of the proteome. Initially, via an exclusive reseller agreement, the solution will be applied to the detection of human parathyroid hormone (PTH) and its variants, which may be useful as biomarkers for bone diseases and diseases of the endocrine system.

As part of the arrangement, Thermo Fisher Scientific will integrate IBI's proprietary immunoenrichment technology with Thermo Scientific automated sample handling and mass spectrometer systems. Scientists at the Biomarkers Initiatives in Mass Spectrometry (BRIMS) Center, a Thermo Fisher Scientific center of excellence, will collaborate with IBI to develop a mass spectrometric immunoassay (MSIA) workflow for research laboratories. Thermo Fisher Scientific will market, distribute and support the solution and the workflow.

"IBI's approach to biomarker analysis relies on our proprietary MSIA technologies for high-throughput, top-down protein assays," said Dobrin Nedelkov, Ph.D., chief executive officer, Intrinsic Bioprobes. "Our protein assays have been used extensively for biomarker analysis and validation, resulting in the discovery of several novel protein variants with important implications. The combination of our MSIA technology and Thermo Fisher Scientific's robust, automated sample handling, mass spectrometry systems and expertise in clinical research workflows, as well as its global distribution and support, will provide clinical researchers with a turnkey solution."

IBI's proprietary immunoenrichment technology is based on its patented pipette tip that integrates a high-throughput, high-binding-capacity microcolumn activated with antibodies. This technology addresses one of the key challenges of biomarker discovery and validation, the isolation and analysis of very low-abundance proteins such as PTH in complex biological matrices.

A key challenge in proteomics research is the ability to differentiate between intact proteins and their variants.

Traditional enzyme-linked immunosorbent assays (ELISA) are limited by the inability of the antibodies to discriminate between all variants and quantify their abundance. A solution is to use the specificity of mass spectrometry to identify and quantitate microheterogeniety. However, many researchers have been stymied by the lack of an integrated, high-throughput mass spectrometry workflow that is robust and reproducible from laboratory-to-laboratory.

"We are extremely enthusiastic about incorporating IBI's proprietary technology into comprehensive workflows that couple immunoenrichment to the power of high-resolution, quantitative, mass spectrometry," said Mary Lopez, Ph.D., director, Thermo Fisher Scientific's BRIMS Center.

"Over the last year, we have worked closely with IBI to develop a reliable, quantitative assay for parathyroid hormone and its variants. This work, recently published in the Journal of Clinical Chemistry, demonstrates a workflow that enables detection and quantification of very-low-abundance intact PTH, and more importantly, several novel PTH protein variants that cannot be detected using conventional assays."