Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF SEPTEMBER 21, 2023 SAM #7968
SPECIAL NOTICE

A -- Improvement of the OraQuick Ebola Rapid Antigen Test

Notice Date

9/19/2023 7:20:14 AM
 

Notice Type

Justification
 

NAICS

541714 — Research and Development in Biotechnology (except Nanobiotechnology)
 

Contracting Office

BARDA - ASPR / DAAPPO / BARDA DCMA WASHINGTON DC 20515 USA
 

ZIP Code

20515
 

Solicitation Number

75A50122C00079
 

Archive Date

10/19/2023
 

Point of Contact

Davis Perkins, Connie Petitjean, Phone: 2026971900
 

E-Mail Address

davis.perkins@hhs.gov, constance.petitjean@hhs.gov
(davis.perkins@hhs.gov, constance.petitjean@hhs.gov)
 

Award Number

75A50122C00079
 

Award Date

09/27/2022
 

Description

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.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/ccf9eb35f05a465c831a9d6b5229b203/view)
 

Place of Performance

Address: Bethlehem, PA, USA

Country: USA
 

Record

SN06836675-F 20230921/230919230050 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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