Improvement of the Oraquick Ebola Rapid Antigen Test Tender, USA - 89186550

Procurement Summary

Country : USA

Summary : Improvement of the Oraquick Ebola Rapid Antigen Test

Deadline : 19 Oct 2023

Other Information

Notice Type : Tender

TOT Ref.No.: 89186550

Document Ref. No. : 75A50122C00079

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

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.
Active Contract Opportunity Notice ID 75A50122C00079 Related Notice BARDA-OTI-06302022 Department/Ind. Agency HEALTH AND HUMAN SERVICES, DEPARTMENT OF Sub-tier OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE Office BARDA - ASPR / DAAPPO / BARDA DCMA
General Information
Contract Opportunity Type: Justification (Updated)
All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
Updated Published Date: Sep 19, 2023 10:20 am EDT
Original Published Date: Sep 30, 2022 10:18 am EDT
Inactive Policy: 30 days after published date
Updated Inactive Date: Oct 19, 2023
Original Inactive Date:
Authority: FAR 6.302-1 - Only one responsible source (except brand name)
Initiative: None

Classification

Product Service Code: AN13 - Health R&D Services; Health care services; Experimental Development
NAICS Code: 541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance: Bethlehem, PA USA

Documents

 Tender Notice

Amendment-to-JA--Redacted.pdf

Amendment-to-JOFOC-CP-JL_Fully-Executed.pdf