1. Initial Market Assessment
High Throughput Method for Plasma Exosomal Lipid Analysis for Early Cancer Detection
2143 1

2. Commercial Opportunity Summary
Title: High Throughput Method for Plasma Exosomal Lipid Analysis for Early Cancer Detection
Key Advantages:
May provide a more accurate detection of exosomes from whole peripheral blood
May provide greater speed of detection with higher reproducibility and ease of use
May provide a platform for new biomarker diagnostics
Market Opportunities: A long standing goal in cancer biology has been to develop tests for early cancer detection through the use of noninvasive methods, most notably liquid biopsies. Exosomes are important biological carriers of information found in circulating blood, lymph, urine and saliva and are considered “representatives” of a cellular phenotype and genotype. The steady state level of circulating exosomes in adult human plasma has been found to be as much as three times higher in individuals with certain carcinomas, and a positive correlation has been established between the level of exosomes and tumor stage in many different cancers. These data suggest exosomes as a clinically applicable biomarker candidate to be included in the rapidly growing molecular oncology diagnostics market. However, current exosome analysis methods are incompatible with clinical laboratories as the methods are too slow, inconvenient, inaccurate and expensive for routine use.
Technology Solution: Researchers at the University of Kentucky have developed a miniaturized microfluidic device that can purify exosomes from small volumes of whole peripheral blood. In contrast to currently available exosome purification methods requiring lengthy incubation periods and limited sample analysis, this device produces a 10-fold higher yield in a fraction of the time. Other advantages, depending on which existing commercially-available test it is compared to, may include superior sensitivity, specificity, convenience, economy of cost, space and technical time. Another major advantage of this test is that it also has the ability to perform FT-MS for quantitative lipid profiling, unlike most PDMS-based microfluidic devices.

3. Inventor Objectives
Expected Grant; Use of Grant Proceeds/
Patent:
Current prototype developments have been funded by inventors’ start up package
Inventors’ have applied for multiple NIH and NCI grants (status pending)
Prototype modifications, testing and refinement
Commercialization
Inventor Timeline:
Grant runs out in May
Finalize antibody library to be used with device
Convert prototype from manual to automatic
Inventor relationships
Started project at University of Louisville; UofL holds a license
Subcontract to University of Alabama Birmingham (UAB)
New device originally apart of startup (provisional patent filed)
Previous communications with BCAL; no future partnerships with them desired
Inventor commercialization goals
Start-up company
Clinical screening tool (diagnostic companies; biotech; clinical laboratories)
Research tool (academic laboratories)
Inventors are seeking a patent to finalize the design, componentization and testing of efficacy and thereafter begin commercialization together with any strategic partners.

4. Technology
High Throughput Method for Plasma Exosomal Lipid Analysis for Early Cancer Detection 4

5. Automated microfluidic devices for cancer diagnostics
The Problem: Current exosomal purification methods are incompatible with clinical laboratories
Classical exosome purification methods from whole blood samples require a lengthy process, large machinery (ultracentrifugation machine) and are limited to a small number of samples that can be purified in a working day.
The technology process is not suitable for clinical laboratories
There is a need for a next generation solution, enabling transition to a high throughput method for plasma exosomal lipid analysis which will outperform the current process in terms of performance, time and cost
Automated microfluidic devices use affinity capture to purify exosomes from whole peripheral blood in a fraction of the time
Automated microfluidic devices deliver 10-fold higher yield of exosomes and greater reproducibility
Automated microfluidic devices are small and can be made disposable for the use in clinical settings as a biomarker diagnostic tool
Differential
Ultracentrifugation
(UC)
The Solution:
Automated microfluidic devices for cancer diagnostics
(automated)
Microfluidic
device 5

6. Technology Development Stage
(e.g., licensed for further development; product design/development)
Advanced Evaluation: (e.g., Beta prototype or working prototype in situ
Evaluation: (e.g., human testing or Alpha prototype
Proof-of-Concept / IP Protection: (e.g., Animal testing and/or patents filed)
Discovery: Basic principles observed and reported
Assessment
Gather
Technology development process / time
Prototype has been developed and tested. Working towards automation
Stage 1
Stage 2
Stage 3
Notes: Current prototype is manual (push-pull method). Still developing custom antibodies. . 6

7. Top Relevant Patent Owners Worldwide
Company Name
Total assets
# of Issued Patents
# of Applications
Avg. of Remaining Life *
Avg. of Priority Year *
The Broad Institute, Inc. 36 -
2013
Reneuron Ltd 28
EXOSOME DIAGNOSTICS, INC. 37
2012
University of Louisville 24 10 14 12
2008
Caris Life Sciences, Inc. 20 9 11
United Therapeutics Corporation
Samsung Electronics Co., Ltd. 8
Roche Holding Ltd. 7
2011
Harvard University
Massachusetts Institute Of Technology
Hitachi, Ltd. 2
The University Of Texas System 6 1
2013 (with one filed in 1998)
Tengion, Inc., Pennsylvania 5
2010
Partners Healthcare System, Inc., Massachusetts
2009 7

8. Relevant Patent Landscape
(using exosome microvesicle)
N =368
1. Technology Landscape. Tools: Innography

9. Active Innovation Landscape
Patent, revenue, and patent enforcement per company
1. Technology Landscape. Tools: Innography.

10. Market
High Throughput Method for Plasma Exosomal Lipid Analysis for Early Cancer Detection 10

11. Market Applications Application 1 Application 2 Application 3
Liquid biopsy diagnostic tool
Research and Development for biotechnology firms
Basic science research tool
Considerations Considerations Considerations
Cancer liquid biopsy market is fastest growing sector;
GRAIL (owned by Illumina) aggregated over $300M in funds for the month of January 2016
US is fastest growing market due to completion of human genome project;
ethical privacy issues;
lack of skilled technicians
A wide range of environment applications and unexploited opportunities are likely to open new market avenues
Source: Carbon Markets.pptx. 11

12. Preliminary Market Takeaways
Market Application
Market Size
Market Growth Rate
Current Consumer Demand
Potential Partners
Notes
Global
liquid biopsy market
$1.6 billion
(2015)
22.3%
5 year CAGR
(cancer sector is 36.2%)
Growing support of medical communities drives growth, specifically clinical evidence
Global oncology molecular diagnostics market
$1.26 billion
(2014)
17.8%
High demand for personalized treatments;
Ethical, privacy and practical issues
Biotechnology Reagents market
$56.4 billion 9%
R&D expenditure triggers growth; rising cost of products and huge R&D expenses impede growth
Key:
= High/Large/many
= Moderate
= Low/Small/few 12