Diagnostic Test Development and Production for Emergency Response

Amendment 0002

The purpose of this amendment is to provide answers to questions submitted by prospective vendors.

Amendment 0001

The purpose of this amendment is to provide answers to questions submitted by prospective vendors and extend the solicitation due date. 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 Contractor will follow their internal practices for optimization of sensitivity and specificity on their automated platform. Sensitivity will need to meet or exceed target provided by CDC based on available data of pathogen level in patient clinical specimens. Specificity will need to be established against near-neighbor pathogens identified by CDC or FDA. Results of optimization will be reported to CDC.

Validation of clinical performance Contractor will validate the performance of the test on their platform using either clinical patient specimens or artificial specimens of the selected specimen type spiked with inactivated pathogen genomic material at levels matching available clinical specimen data. If available, CDC may provide validation specimens from biobanked patient specimens or artificially spike specimens in appropriate matrices.

Validation will be performed in accordance with FDA requirements for EUA/501(k) submission. A report suitable for submission to FDA for EUA and/or 510(k) application will be generated and shared with CDC for review.

Task 3: Test submission for regulatory approval for a selected pathogen Contractor will submit generated validation data package to FDA for EUA approval (if an emergency has been declared) or 510(k) approval (in the absence of an emergency declaration). CDC may grant right of reference to existing CDC test if available. Contractor will respond to any questions or feedback from FDA on test performance, in consultation with CDC. Contractor will be responsible for any post-market monitoring required by FDA.

Task 4: Manufacturing of test for the selected pathogen Contractor will establish sufficient production capacity to meet the outbreak response need as identified by the CDC. Production requirements may vary with the scale of an outbreak, and over time during an outbreak. Target test production capacity may vary from 10,000 tests per week up to >1,000,000 per week for larger outbreak. Contractor will manage test marketing and shipping to diagnostic testing laboratories.

CDC may identify specific laboratories that are providing emergency response surge test capacity, and volumes of tests to be provided to them. Contractor may identify additional accredited diagnostic testing laboratories capable of performing the test and provide additional test volume in accordance with market demand.