Anaphylaxis is associated with PEGylated drugs and mRNA vaccines, as explicitly stated in their FDA-approved labels. Specifically, 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 in particular.

Skin tests are used to diagnose Type I hypersensitivity, but they have some downsides. Particularly skin tests can cause discomfort and localized reactions, such as itching and redness. Sometimes, there is a risk of systemic adverse reactions, including anaphylaxis. These factors may lead to lower patient compliance. For this reason, a sensitive in vitro lab test should be a more acceptable option for patients.

Patented Platform

FocalTuningTM is an innovative in vitro detection platform designed to identify anti-PEG IgE antibodies, which are the primary cause of PEG anaphylaxis. This proprietary technology fine-tunes the PEG-binding properties of antibodies to specifically recognize anti-PEG IgE antibodies without any non-specific signal from the same sample, enabling accurate and sensitive detection of patients who are anti-PEG IgE positive and at high risk of PEG anaphylaxis. By identifying at-risk patients, healthcare professionals can take appropriate measures to prevent serious adverse events and provide personalized treatment options. The patented FocalTuningTM platform and signature PEG IgE detection 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.

FocalTuningTM Platform Flow Chart

Platform Features

♦Removing internal background of each analyte
♦Patented technology
♦Unbeatable accuracy
♥Tiny sample needed (50ul)
♦Super sensitive
♦High specificity

Signature Products

Human PEG IgE Detection Kit

Human PEG IgG Detection Kit

Human PEG IgM Detection Kit

You also may purchase our products from your distributor AmCell Biosciencess, LLC at