Diagnostic Test Development and Production for Emergency Response Tender, USA - 109832065

Procurement Summary

Country : USA

Summary : Diagnostic Test Development and Production for Emergency Response

Deadline : 02 Dec 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 109832065

Document Ref. No. : 75D301-25-R-73207

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

The Contractor shall provide all labor, materials and equipment using current infrastructure and in-house logistics. The CDC will provide all available data on the pathogen genome sequence, primer/probe sequences or recommended targets, specimen type and biosafety guidance for handling specimens. Inactivated validation specimens or inactivated genomic material for use in generating artificial validation specimens may be provided if available.

One or more of the following tasks will be utilized within task orders developed under the IDIQ contract:

Task 1: In collaboration with the CDC, develop a plan for the rapid development and validation of Nucleic Acid Amplification Tests for a selected pathogen in advance of an outbreak.

Identify staff to act as points of contact and direct internal work. Identify all requirements for pathogen data and test target sequences. Establish data exchange mechanisms needed for implementation. Establish working group with CDC and FDA to define minimum EUA validation requirements.Task 2: Development and Validation of Nucleic Acid Amplification Test for a selected pathogen.

Identification of primer and probe target sequences (minimum of 2 targets per pathogen). If available, CDC may provide recommended primer and probe target sequences, Contractor will perform their own internal evaluation of suitability for use on their automated platform. If not available, for a pathogen with no existing labortory developed test, CDC may provide genomic sequence data for the selected pathogen, Contractor will select and identify appropriate targets for primers and probes, ensuring that there are more than 1 target and that the targets distinguish the pathogen from genetic near neighbors specified by the CDC. In the event of an outbreak the CDC may provide genomic sequence data and pathogen samples and request compressed timeframes for development of the test. Development and optimization for sensitivity and specificity...
Active Contract Opportunity
Notice ID : 75D301-25-R-73207
Related Notice : RFI_81580
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : CENTERS FOR DISEASE CONTROL AND PREVENTION
Office: CDC OFFICE OF ACQUISITION SERVICES
General Information
Contract Opportunity Type: Combined Synopsis/Solicitation (Updated)
Updated Published Date: Nov 07, 2024 07:56 pm EST
Original Published Date: Nov 07, 2024 07:52 pm EST
Updated Date Offers Due: Dec 02, 2024 12:00 am EST
Original Date Offers Due: Dec 02, 2024 12:00 am EST
Inactive Policy: Manual
Updated Inactive Date: Mar 01, 2025
Original Inactive Date: Mar 01, 2025
Initiative: None

Classification
Original Set Aside:

Product Service Code: R499 - SUPPORT- PROFESSIONAL: OTHER
NAICS Code: 541380 - Testing Laboratories and Services

Place of Performance: Atlanta, GA 30341 USA

Documents

 Tender Notice

75D301-25-R-73207-Combined-Synopsis-and-Solicitati.pdf

Pricing-Table-Protected.xlsx