Influenza A(H5) Call to Industry 75D301-24-CTI-00001 QA 06.24.2024.xlsx
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- Solicitation number
- 75D301-24-CTI-00001
About this file
This document is a set of questions and answers related to a federal contract opportunity announced by the Centers for Disease Control and Prevention (CDC) for the development and validation of an Influenza A(H5) diagnostic test.
The key details are:
- The CDC is seeking an LDT (lab-developed test) that can be taken through FDA approval to at least the pre-EUA stage. They are open to receiving concept papers for point-of-care testing as well.
- Funding and other negotiated consideration may be provided, and a follow-on manufacturing and/or distribution agreement may be awarded without additional competition.
- The CDC encourages use of open manufacturing practices and is looking for a test design that can differentiate the H5 subtype from other influenza subtypes.
- The performer must be able to manufacture test kits to support testing of a baseline of 1,000,000 unique samples, with the ability to scale up manufacturing efficiently by the end of 2024.
- Providers must be registered in SAM.gov to be considered.
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| File | Type | Posted |
|---|---|---|
| Influenza A(H5) Call to Industry 75D301-24-CTI-00001.pdf |
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Q&A1
| Announcement# 75D301-24-CTI-00001 |
| CDC Open Call to Industry – Influenza A(H5) Diagnostic Test Development and Validation |
Q&A 1 - Released 06/24/2024
| Question | |||
| Number | Question | CDC Response | |
| 1 | Is the subject announcement limited to U.S.-based firms? | CDC does not intend to limit the subject announcement to U.S.-based solution providers only. Providers must, however, be currently registered at www.sam.gov or must register to be considered. | |
| 2 | Is the subject announcement focused only on Lab Developed Testing? | Yes. CDC requires an LDT that can be taken through FDA approval at least up to pre-EUA. | |
| 3 | Is CDC open to receiving concept papers for point-of-care testing? | Yes. If the test is a NAAT-based assay design. | |
| 4 | Is CDC going to provide any funding to do this? | Funding and/or other negotiated consideration may vary per solution. | |
| 5 | At the end of the project does CDC plan to purchase the kits from us to be distributed to the different labs? | An award under 42 USC 242c may result in a subsequent |
award of a follow-on manufacturing and/or distribution agreement without additional competition based on successful prototype completion.
| 6 | Would you be able to help clarify what "open manufacturing" means in the context of this notice or point me to a reference? | While not a requirement, we encourage a test design that utilizes Open Manufacturing practices (https://www.forbes.com/sites/trondarneundheim/2022/04/04/why-we-need-open-manufacturing-and-what-that-would-mean-for-you/). This may include, for example, use of open source design applications or computational resources. |
| 7 | This appears to be a development contract. Do you anticipate a purchase contract to follow? | See the government's response to Question# 5. |
| 8 | This open call addresses readiness for H5 testing. H5 prevalence is currently limited in humans. Do you anticipate the use of this test in other non-human hosts? | The request from the CDC is an assay that is approved for use in humans to prepare for an outbreak or pandemic scenario where testing would immediately scale-up in humans. However, upon meeting deliverables set by the CDC for human testing needs, we would not restrict a company from developing the same or similar assay for use in animals, animal products or environmental testing (e.g. wastewater testing). |
| 9 | What does the government mean by "rough order of magnitude?" Is there a specific template solution providers should follow? | Solution providers must provide the total price/cost estimate for their solution and the individual price/cost estimate for each planned milestone. No specific format/template is required during the concept paper round. |
| 10 | The call to industry is for Influenza A(H5) but the public monitoring website (https://www.cdc.gov/bird-flu/h5-monitoring/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fflu%2Favianflu%2Fh5-monitoring.html) is specific to H5N1. Is there a need for neuraminidase differentiation? | The test design must include the assay's ability to differentiate the H5 subtype from other influenza subtypes. We would not restrict the design to HA only. NA differentiation could be incorporated into the design but it is not a requirement. This is because novel influenza case detection, reporting, treatment, and infection prevention control (e.g. recommendations to isolate) are determined by the HA subtype (with or without NA subtyping). |
| 11 | The open call states that performers must be able to manufacture test kits to support testing of a baseline of 1,000,000 unique samples and the ability to scale-up manufacturing efficiently. Is there a timeframe for ramp up to 1M reactions baseline with a starting threshold? | Ideally, all tasks (including manufacturing of the 1M baseline test capacity) will be fully completed between 11/01/2024 and 12/31/2024. The estimated time to scale-up beyond the initial 1M reactions is not a requirement, but we expect solutions to include considerations for the manufacturing capacity to scale-up beyond baseline if needed. |
| 12 | Please clarify on open manufacturing or open source principles definition? Does this refer to the possibility of allowing for testing by other labs and access to the materials needed for the required scale up in event of a heighten need? | See the government's response to Question# 6. |
| 13 | Please provide additional clarity on the definition of the ROM. Is this cost associated with each of the steps? Do we also need to provide costs associated with testing in a product state when the agreement is issued? | See the government's response to Question# 9. |
| 14 | The Call indicates that the test design should be able to follow the diagnostic testing algorithm “1) by coupling an H5 assay design with an existing A/B typing assays and seasonal virus subtyping assays; 2) developed with typing/seasonal virus subtyping assay components” and we had two different understandings on what the “seasonal virus subtyping assay” means. Can you please confirm which of the following is correct? | A is correct. By 'coupling' with an existing flu A/B typing and seasonal H1/H3 subtyping test, we mean that the H5 subtyping test should be used in a testing algorithm that (ideally) first identifies a sample as flu A positive and 'rules out' seasonal H1 and H3 influenza prior to testing for H5. This is the expected algorithm to increase the positive predictive value of the H5 test and reduce false positives. We do not require that the assay include other subtypes besides H5 as long as there is demonstration of an appropriate testing algorithm. |
| A. The assay is not mandated to subtype between Flu A H1 ~ H7. H5 should be detected separately. |
If this is correct understanding, then no additional subtyping between Flu A H1~H7.
B. The assay should subtype Flu A H1 ~ H7 and detect H5 separately If this is what CDC requires, subtyping between H1~H7 will be needed.
15 Is the subject announcement restricted to manufacturing of test "kits" or is it intended for labs to create their own internal production of an Immediate Response Test for internal use (after FDA EUA clearance)? (That is, is this announcement intended for a response from those companies capable of a “developing and validating and provide an internal testing service” or is it intended for a response from commercial test kit manufacturers?) The subject announcement is intended for a response from commercial test kit manufacturers to develop and manufacture a test that could be provided to other entities to perform testing. This could also include internal testing services but not exclusively.
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