Improvement of the OraQuick Ebola Rapid Antigen Test
Awarded Limited / Sole Source Justification Posted
- Solicitation number
- 75A50122C00079
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75A50122C00079 Federal contract award
- Awardee
- Orasure Technologies Inc.
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Place of performance
- Bethlehem, Pennsylvania, United States
Notice details come from SAM.gov. Updated .
About this opportunity
This Limited/Sole Source Justification Notice from the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response seeks to improve the OraQuick Ebola Rapid Antigen Test under contract number 75A50122C00079, originally awarded to OraSure Technologies on September 27, 2022 for an unknown amount. Specifically, the scope of work will make the Ebola test independent of limited critical reagents, improve manufacturing capabilities and test performance, and obtain new FDA clearance, including analytical and clinical validation studies. OraSure Technologies is uniquely qualified as the sole source vendor due to being the only contractor with an FDA cleared rapid antigen test for Ebola that addresses public health needs.
Notice text
2 versions
Update #2 · Latest ·
This requirement is to improve the OraQuick® Ebola Rapid Antigent Test. The OraQuick® Ebola Rapid Antigen Test 510(k) was cleared by FDA in October 2019. As of June 2022, there is limited supply of critical reagents (both control and diagnostic antibodies) used in the Ebola 510(k) cleared device. The Government seeks to make the Ebola 510(k) cleared device independent of the aforementioned critical reagents, improve manufacturing capabilities, sensitivity and shelf in order to better respond to public health emergencies. Therefore, the project scope will be expanded beyond preliminary device performance testing, with a goal to improve the quality of the test performance and stability.
The attached J&A amendment approved on 9/14/2023 increases the J&A ceiling and revises the Statement of Work to include the completion of analytical and clinical validation studies and regulatory activities for 510(k) clearance of the second-generation OraQuick® Ebola Rapid Antigen Test. The modification was determined to be in-scope.
Awarded contract 75A50122C00079 to unknown vendor for unknown amount on 2022-09-27.
Update #1 ·
This requirement is to improve the OraQuick® Ebola Rapid Antigent Test. The OraQuick® Ebola Rapid Antigen Test 510(k) was cleared by FDA in October 2019. As of June 2022, there is limited supply of critical reagents (both control and diagnostic antibodies) used in the Ebola 510(k) cleared device. The Government seeks to make the Ebola 510(k) cleared device independent of the aforementioned critical reagents, improve manufacturing capabilities, sensitivity and shelf in order to better respond to public health emergencies. Therefore, the project scope will be expanded beyond preliminary device performance testing, with a goal to improve the quality of the test performance and stability.
Awarded contract 75A50122C00079 to unknown vendor for unknown amount on 2022-09-27.
Files
| File | Type | Posted |
|---|---|---|
| Amendment to JA - Redacted.pdf | ||
| Amendment to JOFOC-CP-JL_Fully Executed.pdf | ||
| Justification and Approval - Other Than FAO.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Limited / Sole Source Justification | |
| Improvement of the OraQuick Ebola Rapid Antigen Test | Special Notice |
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