FAQs for Step 3 of the AMR Diagnostic Challenge Competition

 

  • Is Step 3 of the AMR Diagnostic Challenge competition open to the public and/or individuals/teams who submitted previously to either Step 1 or Step 2 of the competition?

Response:  Step 3 of the AMR Diagnostic Challenge competition is only open to the 5 Semi-Finalists from Step 2 of the competition.  The five Step 2 Semi-Finalists can be found on https://dpcpsi.nih.gov/AMRChallenge/FinalistsAnnouncement

  • What does Step 3 of the AMR Diagnostic Challenge competition involve?

Response:  Step 3 of the AMR Diagnostic Challenge competition involves the testing of the Step 2 Semi-Finalists’ in vitro diagnostic prototypes by two independent CLIA-certified laboratories to assess the performance of the assays compared to the performance claims from the Step 2 Semi-Finalists and FDA-approved assays.

  • Where can I find additional information on the submission requirements and criteria for this stage of the competition?

Response:  Submission requirements for Step 3 of the AMR Diagnostic Challenge competition can be accessed either in the Federal Register Notice issued on January 29, 2019, or the Announcement in the NIH Guide for Grants and Contracts issued on January 9, 2019.

  • Have the two independent CLIA-certified laboratories been selected and will Step 2 Semi-Finalists be provided the names of these laboratories? Have these laboratories signed non-disclosure agreements?

Response:  The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.  The two CLIA-certified laboratories have been selected.  To ensure independent testing of the “submissions,” the laboratories will not be identified to the Step 2 Semi-Finalists or anyone else outside of the government review process.  These laboratories and their personnel have signed non-disclosure agreements (NDAs) that have been reviewed by both Capital Consulting Corporation (CCC), NIH, and BARDA.  Any real or perceived conflicts of interest between these laboratories and the Step 2 Semi-Finalists also have been reviewed to ensure the laboratories’ ability to independently perform the testing.

  • Do the two CLIA-certified laboratories have the technical skills and expertise to conduct the performance evaluation of the Step 2 Semi-Finalists’ in vitro diagnostic prototypes? When will the performance evaluation testing be conducted?

Response:  The two CLIA-certified laboratories have highly trained technical staff to perform the testing of the in vitro diagnostic prototypes submitted by the Step 2 Semi-Finalists.  These laboratories were selected based on their previous experience in performing CLIA-validation/verification testing of in vitro medical diagnostics.  Testing of the Step 2 Semi-Finalists’ prototypes will be conducted from January 2020 through April 2020.

  • Will Step 2 Semi-Finalists submit their diagnostic prototypes, consumables, and reagents to CCC or to the two CLIA-certified laboratories?

Response:  As indicated in the Federal Register Notice, each Step 2 Semi-Finalist will need to provide two sets of prototype devices, reagents, consumables, etc. so that each CLIA-certified laboratory can independently assess the performance of the prototypes.  This will require that each Step 2 Semi-Finalist send two parcels/crates with these contents (one set for each testing laboratory) to CCC which will then arrange shipment to the two CLIA-certified laboratories.  There will be no direct contact between the Step 2 Semi-Finalists and the two CLIA-certified laboratories to ensure that there is independent testing of the in vitro diagnostic prototypes.

  • Will the Step 2 Semi-Finalists provide on-site setup, training, and/or onsite technical assistance to the two independent CLIA-certified laboratories?

Response:  The Step 2 Semi-Finalists will not have any contact with the two CLIA-certified laboratories to ensure an independent assessment of the “submissions.”  Based on the information provided by the Step 2 Semi-Finalists in their Step 2 and Step 3 written submissions, the two CLIA-certified laboratories will setup the instrumentation and assays.   If these two laboratories have any questions about setting up the instrumentation or performing the assay, they will submit the questions to CCC which in turn will contact the appropriate Step 2 Semi-Finalist.  The Step 2 Semi-Finalists will not provide onsite assistance or have any direct contact with these laboratories.

  • What is the testing protocol that the two independent CLIA-certified laboratories will use for the performance evaluation of the Step 2 Semi-Finalists in vitro diagnostic prototypes? Will the Step 2 Semi-Finalists be provided with the same protocol so that they can assess the performance of their in vitro diagnostic prototypes?

Response:  A protocol has been developed by NIH, BARDA, CDC, and the two independent CLIA-certified laboratories to evaluate the performance of the in vitro diagnostic prototypes compared to FDA-approved in vitro assays. The protocol will be provided to the Step 2 Semi-Finalists for their own assessment of their diagnostic prototypes.

  • What types of biospecimens will be used in the performance evaluation conducted by the two CLIA-certified laboratories? Will the Step 2 Semi-Finalists need to provide biospecimens to the testing laboratories?

Response:  The two CLIA-certified laboratories are embedded in major medical centers and have access to patient samples including blood, urine, CSF, and other specimens.  In addition, these laboratories will use well-characterized panels of specimens from the CDC  and FDA Antibiotic Resistance Isolate Bank and/or contrived samples using these isolates to assess the performance of the in vitro diagnostic prototypes submitted by the Step 2 Semi-Finalists.

  • Will the prototype instruments be returned by the two CLIA-certified Laboratories to the Step 2 Semi-Finalists?  Will the Step 2 Semi-Finalists pay for the return shipment of the prototype instruments?

Response:  Instrumentation will be returned to the appropriate Step 2 Semi-Finalist following relevant decontamination processes.  Return shipment of the instruments will not be charged to the Step 2 Semi-Finalists.

  • Is the Step 2 Semi-Finalist responsible for the cost of the performance evaluation by the two CLIA-certified laboratories?

Response:  Step 2 Semi-Finalists will not be responsible for the cost of the performance evaluation.

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