Tackling PEG anaphylaxis

Tel: 001-650-996-6078; Email: info@LeadingLifeTechnologies.com

blood test of peg ige

For non-invasive screening of PEG anaphylaxis

The U.S. market for PEGylated drugs has experienced rapid growth, surpassing USD 6 billion in 2017 and projected to exceed USD 8 billion by 2024, according to Global Market Insights. These therapies, which use polyethylene glycol (PEG) to enhance drug stability and bioavailability, have become increasingly vital in oncology, immunology, and rare disease treatment. However, as their use expands, so too does concern over safety. While it is well-established that some PEGylated drugs can trigger acute hypersensitivity and anaphylaxis, emerging evidence now points to PEG itself—not just the drug component—as a direct cause of severe allergic reactions in a sensitized subset of individuals.

To address this critical safety gap, Leading Life Technologies (LLT) has developed a powerful solution based on its patented FocalTuning™ immunoassay platform (US10,914,731B2; US11,835,517B2; ZL202080015982.5). This technology enables highly sensitive and specific detection of anti-PEG IgE, a key biomarker of PEG-induced anaphylaxis. By delivering accurate results even at picogram levels, FocalTuning helps researchers, pharmaceutical developers, and clinicians detect PEG sensitization with unparalleled clarity—especially in cases where traditional skin tests or ELISAs fall short. This allows for better safety profiling of PEGylated products across preclinical development, clinical trials, and post-market surveillance.

LLT’s PEG IgE detection products and services are designed to support both drug developers and healthcare providers in making informed, patient-centered decisions. By identifying individuals at risk for PEG-related hypersensitivity early in the treatment process, FocalTuning empowers pharmaceutical innovation without compromising safety. As the therapeutic landscape continues to evolve, LLT remains committed to bridging the gap between cutting-edge drug development and precision diagnostics—helping ensure that PEGylated therapies are not only effective, but also safer for every patient.

pre-

clinical

We screen PEGylated drug candidates using human basophil and mast cell models to evaluate their potential to trigger immediate hypersensitivity and anaphylaxis. These immune cells are central to allergic reactions, and by assessing how PEGylated compounds interact with them, we gain critical insight into their safety profiles. This approach enables us to identify and refine safer drug candidates early in development, helping biopharmaceutical companies reduce the risk of adverse reactions and enhance patient safety.

clinical trial

Enhancing the safety of PEGylated drugs begins with identifying individuals at risk for severe allergic reactions. Our patented platform enables ultra-sensitive detection of anti-PEG IgE, allowing early screening of vulnerable subjects who may experience immediate hypersensitivity or anaphylaxis. By excluding high-risk individuals during preclinical and clinical testing, pharmaceutical companies can reduce adverse events, protect patient safety, and streamline regulatory approval. This approach supports the development of safer, more effective therapies and increases the likelihood of FDA approval for new PEGylated drug candidates.

post-marketing

Enhancing the post-marketing safety of PEGylated drugs begins with precise PEG IgE screening. Our advanced platform identifies individuals at high risk for PEG-induced anaphylaxis, enabling clinicians to take preventive measures or select safer alternatives. By detecting vulnerable patients early, we reduce the risk of severe allergic reactions. This strategy not only safeguards patient health but also supports pharmaceutical companies and providers in meeting regulatory standards, improving therapeutic outcomes, and sustaining public confidence in PEGylated drug safety.

Vision

Improving health and saving lives with innovation-driven technologies

History

Founded in 2012 by Stanford researcher. We embrace a brilliant tomorrow.

People

Scientists are teamed up with different professionals.

Location

Based in the heart of Silicon Valley, California.

FocalTuningTM platform

for PEG IgE detection and beyond