| NSF Org: |
TI Translational Impacts |
| Recipient: |
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| Initial Amendment Date: | July 19, 2016 |
| Latest Amendment Date: | July 19, 2016 |
| Award Number: | 1643528 |
| Award Instrument: | Standard Grant |
| Program Manager: |
Steven Konsek
TI Translational Impacts TIP Directorate for Technology, Innovation, and Partnerships |
| Start Date: | August 1, 2016 |
| End Date: | July 31, 2017 (Estimated) |
| Total Intended Award Amount: | $50,000.00 |
| Total Awarded Amount to Date: | $50,000.00 |
| Funds Obligated to Date: |
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| History of Investigator: |
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| Recipient Sponsored Research Office: |
4300 MARTIN LUTHER KING BLVD HOUSTON TX US 77204-3067 (713)743-5773 |
| Sponsor Congressional District: |
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| Primary Place of Performance: |
4800 Calhoun Boulevard Houston TX US 77204-2015 |
| 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): | I-Corps |
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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 I-Corps project is the development of a commercial antigen retrieval solution that will be used in academic, government and industrial research laboratories as well as hospitals worldwide with applications for the detection of protein and molecular biomarkers. Formaldehyde is a widely used to preserve tissue in both laboratory and clinical settings. Current tissue-based diagnostic applications for the detection of biomarkers are limited due to the requirement of formaldehyde fixation of tissue samples. Due to a loss of sensitivity associated with formaldehyde fixation, many clinically relevant biomarkers cannot be reliably studied with current technology, resulting in false-negative errors. Due to the financial cost and the effect of misdiagnosis on treatment outcomes associated with false-negative errors in clinical diagnostic testing, the development of improved antigen retrieval technology will have important societal and medical impacts. Given that there are more than 93 million diagnostic tests run worldwide that depend on antigen retrieval agents, the technology is anticipated to have substantial commercial potential in clinical settings.
This I-Corps project demonstrates how the detection of protein-epitopes in formalin-fixed paraffin-embedded tissue can be retrieved with higher sensitivity and reproducibility by using formaldehyde scavenging compounds. Current antigen retrieval reagents typically contain sodium citrate or Tris based solutions that rely primarily on heat to reverse formalin fixation from tissue samples. The proposed project expands on the current methods by using chemistry associated with formaldehyde scavenging to significantly enhance the detection of proteins in formaldehyde-fixed tissue samples. The proposed approach consists of novel compositions that contain combinations of formaldehyde scavenging compounds. Currently, we have demonstrated increased sensitivity with a series of structurally diverse compounds using a panel of blood vessel proteins as a model system. This method provides a new and more accurate method for the detection of proteins in tissue-based diagnostic assays used in clinical and research applications.
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.
The vast majority of tissues used for biomedical research are preserved with formaldehyde-containing solutions, a process that limits tissue degradation through chemical modification. While this process preserves tissues, the chemical modifications associated with formaldehyde fixation can substantially impact the detection of protein biomarkers in diagnostic tests. Due to the loss of sensitivity that is associated with fixation by formaldehyde, the detection of clinically relevant biomarkers can be negatively affected, resulting in false-negative errors. These false-negative errors can have significant impacts on the development of diagnostic tests. The antigen retrieval technology in this project eliminates many of the chemical modifications associated with formaldehyde fixation, reducing the loss of sensitivity and development of false-negative errors, and improving the quality of diagnostic tests. Given that there are more than 93 million diagnostic tests performed annually, we anticipated that our anti-retrieval technology would have substantial commercial potential. Through the NSF I-Corps program, we interviewed more than 100 potential users of the technology who were involved in the use and development of diagnostic tests. Through the process of conducting customer interviews, we discovered a prominent potential market for this technology was associated with users involved in the development of new diagnostic tests. Our technology was particularly appealing to product development managers and scientists within companies developing new medical tests; the increased sensitivity and reduction in false negatives represented essential value propositions. Furthermore, this technology appeared to have greatest value when it was incorporated into the development of new tests, rather than pairing the technology with existing tests. The NSF I-Corps program created a framework that has allowed us to validate the market need for improved antigen retrieval technology and has allowed us to redirect our focus to areas of greatest commercial need. Funding provided through the I-Corps program substantially contributed to the training of the PI and EL, who have started the company to address current market needs associated with technology. Our team’s successful completion of the I-Corps program has translated into the development of a new biotechnology business within the state of Texas; the improved antigen retrieval products and has allowed the company to make clear inroads into markets associated with detection of clinically relevant biomarkers.
Last Modified: 11/01/2017
Modified by: Jason Eriksen
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