Exosome technology to Enable Diagnostics

Principal Investigator:Andrew M. Wo, Professor

Breast cancer is the main cause of mortality among women. Current approach to assess therapeutic efficacy primarily uses CT scan to measure primarily tumor size. However, this modality exposes patients to x-ray hence is limited to usage once every 3 months, hindering real-time assessment of treatment efficacy or drug resistance. Early assessment of treatment response to anti-cancer treatment should significantly improve patient outcome. Exosomes have been demonstrated to represent cells of origin with characteristics of early dissemination. Yet, establishing the clinical utility of exosome has been limited by their small size and the extensive sample preparation required prior to analysis.

The goal of this project is to develop a blood-based device to assess treatment efficacy for HER2 and triple negative (TN) breast cancer (BC) patients. The unique capability of our electro-microfluidic technology enables isolation of exosomes from body fluidics, such as whole blood (serum or plasma), and to detect exosomal protein. On-chip protein measurement is also integrated to perform seamless point-of-care diagnostics.

Product highlights:

    • Real-time information in the early detection and monitoring of anti-cancer treatment.
    • Non-invasive liquid biopsy, only a small amount of sample, such as blood, serum and plasma need be used for measurement.
    • Miniature fluidic devices for rapid exosome isolation and protein analysis.
    • Flexible platform enables the exploration of diverse cancer indications as well as other diseases.
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Team Introduction

Our vision is to invent novel technologies to tackle unmet clinical diagnostic needs.

As the co-founder of two companies, the PI has a wealth of experience with commercialization and start-ups. He also has served as the Associate VP (R&D) of NTU, Director of the Center of Industrial-Academic Cooperation responsible of IP and tech transfer of all NTU technologies, and Director of NTU Incubator.

The PI’s team has expertise in microfluidics, optics, biotechnology, microfabrication, biostatistics and regulatory affairs. Dr. Jean Paul Thiery is the discover of the cellular program epithelial-mesenchymal transition (EMT) critical in cancer progression. Dr. C.S. Huang is the Chair of Dept. of Surgery, NTUH. Dr. C.S. Lin, a retired FDA Director, is an expert on regulatory affair. Dr. F.C. Hu is an expert on biostatics. Results of the team have been published in high-impact journals and 13 patents have been issued (6 US, 6 Taiwan and 1 China).

Goals and Plan
Entry Barrier

The disruptive patent-pending technology in this project is to use blood-based nanoparticles to enable monitoring of breast cancer for HER2 and triple negative patients during therapeutic treatment. Unlike current techniques for exosome isolation which requires extensive sample operation and the need for expensive equipment, our electro-microfluidic platform utilize electrokinetic force to isolate and enrich exosomes from blood, as well as exosomal protein measurement is integrated on the platform to realize point-of-care/testing (POCT).

Market Scope

Market forecast for exosomes is a very strong CAGR of 18.8% and reach US$ 2.28B by 2030. This clinical market has also been proven by Exosomes Diagnostics, the first mover in this field. Since Jan 2017, the company has provided prostate and lung cancer diagnostics via exosomes. Exosomes Diagnostics processed nearly 1,000 samples daily. This proves the clinical utility of exosomes for diagnostics.

In 2012, an estimated 1.67 million new breast cancer (BC) cases were diagnosed, which shows more than 20% increase since 2008. A significant BC increase has been observed in Asia with younger median age as well as higher rate of HER2+/TN status. Our first assay will monitor treatment efficacy for HER2 and triple negative BC patients. We expect to launch the product in 2020 after FDA approval, the market share forecast is US$134 million for 2% market share in 2025. Further market penetration will be explored through other cancer indications.

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