Sensitive, specific and accurate determination of an analyte or biomarker is critical for diagnosis, therapy, drug & vaccine safety. However, the complex nature of sample matrices poses a challenge to obtaining a reliable result, especially for those analytes and biomarkers with low abundance but high significance. For example, IgE-mediated anaphylaxis is life-threatening. Detection of pre-existing allergen-specific IgE can identify individuals at risk. By removing the internal background of each analyte, our proprietary FocalTuning™ platform and products (US10,914,731B2, 2021; US11,835,517B2, 2023; ZL202080015982.5, 2024) can detect and quantify low level analytes such as polyethylene glycol (PEG) specific IgE, which has received increasing attention in severe hypersensitivity reactions of PEG and PEG-containing products, including food, cosmetics, daily life products, mRNA vaccines and PEGylated drugs. This general platform can also be applied to the early diagnosis of various diseases including cancer.
The technological advantages of FocalTuning™ platform include, but are not limited to
- Ability to multiplex
- Ability to scale up
- Powerful statistics
- Ability of rapid analysis, typically thousands of beads in seconds
- Small sample volume, typically 100ul
- Pair-based internal calibration of every single analyte
- Customized background removal of every single analyte
- Tens and hundreds of analytes can be measured simultaneously