| NSF Org: |
TI Translational Impacts |
| Recipient: |
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| Initial Amendment Date: | December 2, 2019 |
| Latest Amendment Date: | October 15, 2020 |
| Award Number: | 1938096 |
| Award Instrument: | Standard Grant |
| Program Manager: |
Henry Ahn
hahn@nsf.gov (703)292-7069 TI Translational Impacts TIP Directorate for Technology, Innovation, and Partnerships |
| Start Date: | January 1, 2020 |
| End Date: | June 30, 2021 (Estimated) |
| Total Intended Award Amount: | $224,998.00 |
| Total Awarded Amount to Date: | $269,996.00 |
| Funds Obligated to Date: |
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| History of Investigator: |
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| Recipient Sponsored Research Office: |
12358 PARKLAWN DR STE 280 ROCKVILLE MD US 20852-2176 (847)502-4007 |
| Sponsor Congressional District: |
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| Primary Place of Performance: |
NY US 14850-4281 |
| Primary Place of
Performance Congressional District: |
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| Unique Entity Identifier (UEI): |
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| Parent UEI: |
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| NSF Program(s): | SBIR Phase I |
| Primary Program Source: |
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| Program Reference Code(s): |
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| Program Element Code(s): |
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| Award Agency Code: | 4900 |
| Fund Agency Code: | 4900 |
| Assistance Listing Number(s): | 47.084 |
ABSTRACT
The broader impact/commercial potential of this project will explore the development the High Efficiency Rapid Magnetic Erythrocyte Separator (H.E.R.M.E.S), a highly translational blood-plasma separation system enabling the decentralization of commercial blood testing. Blood testing is currently limited to centralized testing labs due to the requirements of centrifugation, a key first step in the majority of diagnostic testing. However, centrifuges are not suitable for use at the point-of-care and have created a bottleneck in the translation of bench-to-bedside testing. H.E.R.M.E.S is a unique magnetic bead-based separation method to quickly obtain plasma free of red blood cells. The technology is a low-cost and standalone platform with the potential to augment the testing efficiency and translational ability of existing blood-based diagnostic tests. Specifically, this effort will examine the potential for H.E.R.M.E.S to augment Human Immunodeficiency Virus (HIV) diagnostic and viral load quantification testing in finger-stick and whole blood, when used with standard lab-based and rapid diagnostic assays. Access to higher quality HIV tests will have a major impact for public health and improved diagnostic outcomes. H.E.R.M.E.S will address the lack of availability of low-cost and efficient sample processing technologies and help introduce the next generation of robust point-of-care blood tests.
This Small Business Innovation Research (SBIR) Phase I project will enable the implementation of a magnetic-bead based separation assay to achieve low-complexity and rapid blood-plasma separation in point-of-care testing environments. The technology will enhance current blood-testing capabilities at the point-of-care and has the potential to enable the development of highly robust diagnostic tests. This Phase I effort will demonstrate the feasibility of the underlying technology for companion use with commercially existing laboratory-based and rapid diagnostic HIV assays. The compatibility of the separation assay will be verified by comparing the performance of the diagnostic assay with different sample types: blood, centrifuged plasma and H.E.R.M.E.S plasma. This proposal will explore the potential to use the unique sample type generated by H.E.R.M.E.S to enhance HIV diagnostic testing outcomes by providing earlier detection. The end result is a device that can process blood into a sample that will augment the performance of blood-based diagnostic testing.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
PROJECT OUTCOMES REPORT
Disclaimer
This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.
This SBIR Phase 1 project explored the development the High Efficiency Rapid Magnetic Erythrocyte Separator (H.E.R.M.E.S), a highly translational blood-plasma separation system that will enable the decentralization of commercial blood testing. H.E.R.M.E.S is a unique magnetic bead-based separation method to obtain plasma free of red blood cells in a short amount of time. The technology is a low-cost and standalone platform that has the potential to augment the testing efficiency and translational ability of existing blood-based diagnostic tests. H.E.R.M.E.S will address the lack of availability of low-cost and efficient sample processing technologies and help usher in the next generation of robust point-of-care blood tests.
During this effort, we focused on verifying two elements of our value proposition with regards to lateral flow assays and molecular testing with Objectives as follows:
Objective 1 - The High Efficiency Rapid Magnetic Erythrocyte Separator (HERMES) can improve the performance of rapid lateral flow assays using SARS- COV-2 rapid antibody tests and 4th generation HIV rapid tests
Objective 2 - HERMES can facilitate point-of-care molecular testing with a compatible and potentially uniquely advantageous sample type that can be obtained without centrifugation.
The work conducted presents a key step towards enabling the implementation of a magnetic-bead based separation assay to achieve low-complexity and rapid blood-plasma separation in point-of-care testing environments. The technology will enhance current blood-testing capabilities at the point-of-care and has the potential to enable the development of highly robust diagnostic tests. This Phase 1 effort demonstrated the feasibility of the underlying technology for companion use with commercially existing SARS-COV-2 serology and rapid diagnostic HIV assays. We compared the performance of blood, centrifuged plasma and H.E.R.M.E.S plasma with these diagnostic tests and demonstrated that H.E.R.M.E.S plasma is superior to plasma and whole blood when used with conventional molecular testing techniques. Successful development and commercialization of the underlying technology will likely result in a refined ecosystem with greater availability to accurate blood-based diagnostic tests
Last Modified: 04/13/2021
Modified by: Sasank Vemulapati
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