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A Label-free Extracellular-vesicle Automated Purification System (LEAP System)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44GM144009-02
Agency Tracking Number: R44GM144009
Amount: $1,498,809.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 400
Solicitation Number: PA21-259
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-07-01
Award End Date (Contract End Date): 2024-06-30
Small Business Information
160 E Tasman Dr.
San Jose, CA 95134
United States
DUNS: 081096834
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (814) 777-8586
Business Contact
Phone: (925) 316-3846
Research Institution

Extracellular vesicles (EVs) are small lipid bilayer particles secreted by most cell types, which encapsulates
biomolecules including lipids, proteins, and nucleic acids from cells of origin. Profiling of EV-derived biomarkers
provides a promising approach for diagnosis of various diseases. However, one of the primary challenges for
the research and application of EVs is a lack of a reliable method for efficient isolation of EVs and their
subpopulations from complex biofluids. Researchers in this field suffer from tedious workflow, long processing
time, high cost, and poor EV quality. To overcome the challenges, WellSIM proposes in this Phase II project,
which built upon the promising results generated from our Phase I project, to complete development of a Label-
free Extracellular-vesicle Automated Purification System (LEAP System) for isolation of total EVs or EV
subpopulations from a variety of biofluids in a non-invasive and cost-effective manner. Once developed, the
integrated LEAP System will offer excellent EV quality, throughput, and flexibility for EV isolation that can
outperform ultracentrifugation and other isolation techniques.

* Information listed above is at the time of submission. *

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