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- The utility of biomarkers in cancer diagnostics has been disappointing because of limitations in diagnostic accuracy due to its weak connection with the underlying cancer biology
- Tumor cells process post-translational modifications to proteins differently compared to normal cells, and additionally, these proteins interacts sometimes differently with other proteins.
- Monoclonal antibodies cannot distinguish between differences in these isoforms from healthy and malignant cells
- Recent studies have shown that measuring a different parameter, the ratio (K) between isoforms partitioned in a biphasic system can detect cancer-related changes to the structure and significantly improve the clinical value of a biomarker.
- A new technoloy called Solvent Interaction Analysis™ or SIA™ can be applied as a pre-step to conventional ELISA to significantly improved clinical performance of many existing biomarkers.
That's where you come in.
- A structure-sensitive assay combines two steps: the SIA assay (Cleveland Diagnostics) and the presently available proprietary ELISA of the biomarker (Partner)
- An especially powerful concept in the SIA-based development cycle is the lack of need for a priori assumption of mechanistic/structural information about specific modifications to the biomarker. This concept is especially useful in cancer, where the disease genetic heterogeneity may lead to a plethora of structural isoforms
- The SIA assay will by design be sensitive to the actual distribution of structural changes since it is developed with representative sets of case/control clinical samples.
We work with you to assist you in developing the customized SIA reagents for the test, with you being the responsible party to develop the Lab Developed Test specific to your biomarker under CLIA regulations.
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