Solution
Anaphylaxis is associated with PEG-contained products, PEGylated drugs and mRNA vaccines, as explicitly stated in the FDA-approved labels. Anaphylactic reactions to the PEG component of these drugs and vaccines have been reported in real-world practice, highlighting the need for improved safety measures targeting PEG itself. Invasive Skin testing with PEG cause patient’s discomfort and local reactions, such as itching and redness. In rare but severe cases, skin testing can trigger systemic adverse reactions, including life threatening anaphylaxis. These factors reduce patient compliance. Therefore, a non-invasive test for PEG allergy and anaphylaxis is desperately needed but not available until our products are developed.
Our non-invasive solution is simple, straightforward and trustworthy. The ultimate goal is, if one’s blood test is anti-PEG IgE positive by our kits, please don’t contact and keep away from any PEG and PEG containing products and drugs; if negative, you can free yourself from this worry. As a useful pre-screening test, these results also improve drug safety for mRNA vaccine and PEGylated biopharmaceutical companies.
All our products are for research use only for now.
Patented Technology
FocalTuningTM is a general immunoassay platform based on paired cytometric bead assay (PCBA, or so-called dural cytometric bead assay, DCBA). The core design of this platform is targeted to removing non-specific background signal within each individual samples. One of its applications is for the detection of anti-PEG IgE antibody. This proprietary platform and products (US10,914,731B2, 2021; US11,835,517B2, 2023; ZL202080015982.5, 2024) fine-tunes the PEG-binding properties of antibodies to specifically recognize anti-PEG IgE without non-specific signal from the same sample, enabling accurate and sensitive detection of anti-PEG IgE positive patients at high risk for PEG anaphylaxis. By identifying at-risk patients, healthcare professionals can take appropriate action to prevent serious adverse events and provide personalized treatment options. The patented FocalTuningTM platform and signature human PEG IgE detection kit products represent a promising approach to minimizing or even eliminating the growing concern of PEG-related severe immediate allergic reactions to PEGylated drugs in clinical settings. This PEG safety testing kit is the first product on the market strived to meet the urgent need for non-Invasive PEG anaphylaxis testing.
Human PEG IgE Detection Kit
This anit-PEG IgE kit performance has been validated against FDA’s in-house assay.
