AoI-0001_FA811921SC001-RAPID POINT OF CARE TESTING Rev03.pdf

AoI-0001_FA811921SC001

RAPID POINT OF CARE TESTING

GENERAL INFORMATION

1.0 Rapid point-of-care and point-of-use COVID testing Area of Interest (AoI) Background Significantly increasing the U.S. access to accurate, easy-to-use, point of care (POC) technologies with potential for in-home use will be critical to getting Americans back to work safely. These technologies can also serve as platforms for responding to future pandemics and managing ongoing medical challenges (e.g. influenza).

Given the technological, regulatory, and execution challenges at hand, we have established a collaboration between the Department of Health and Human Services (HHS) (Office of the Assistant Secretary, Biomedical Advanced Research and Development Authority (BARDA), National Institute of Health (NIH)), and the United States Air Force (USAF) to understand the industry’s ability to rapidly mature and scale POC testing technology with the potential for in-home use. This could include molecular, antigen, or any other underlying methodology for SARS-CoV2 detection, provided it passes regulatory review.

Submissions do not need to have an existing U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), but need to be willing to submit evidence of ongoing FDA interactions potentially leading to an EUA in support of submission.

2.0 AoI expansion request

This AoI solicits white papers or solution briefs from all vendors who believe they can meet Health and Human Services Assistant Secretary for Health priorities for maturing and scaling technology that will make testing more accessible, affordable, and effective in the US. The desired respondents are those vendors who have developed or are developing products that meet the following requirements:

- Have potential for use in an in-home setting (price, portability, ease of use)

- Have potential to achieve manufacturing production rates of 100K – 1M tests/day within 3-4 months of contract award

- Received an EUA, or have intent to submit an EUA, for point of care testing for SARS-CoV2 by

15 January 2021

- Can provide rapid screening or testing results for SARS-CoV-2 virus nucleic acid or antigen with a turnaround time not exceeding 30 minutes

- Manufactured in an ISO 13485 registered or better production process

- CLIA waivable product

In addition to the above requirements, there is also a desire (but not required) for respondents who have developed or are developing products that also have:

- Interface & test result reporting potential through cell phone or tablet

- Can potentially be adapted or expanded to test for additional viruses

Throughout this AOI, the term “test” is used to refer to any machine, kit, assay, analyzer, device, including supporting components that can be used to either screen for or diagnose SARS-CoV-2. The term “components” can include but is not limited to: swabs, media, pipettes, reagents, cartridges, and manufacturing efforts that support production of these items.

Respondents should address the following questions and requests in their responses: - Please provide descriptive information about the test and components:

o The underlying technology o How the test works, including potential throughput or capacity and interface potential o Specifics related to specimen collection o Performance results in terms of lower limit of detection, sensitivity, specificity, positive and negative agreement with PCR based testing and/or similar metrics o Supporting evidence from any lab or clinical trials, including who conducted those trials o The estimated per-test cost (with quantity breakpoints) o Technical training required to operate and/or how the test could be operated OTC (home use) o What other diseases the test could potentially be used for and what the nature of the product changes would need to be made to do so

- Please provide current status of technology in its go-to-market journey:

o Status of any EUA’s or EUA applications o Status of participation in any other Federal testing programs or procurements (e.g. NIH

RADx) o Status of participation in any programs or trials outside of the federal government o What aspects of the test or its components could be considered a hurdle or barrier to approval for in-home use (e.g. tamper-proof casing, hazardous materials, etc.)

- Please provide operational information about ability to scale volume of tests o A brief overview of your current manufacturing process to include if ISO 13485 registered or better production process is utilized o Current production volumes o What the potential ramp-up of manufacturing could be once the test is approved for use and funding is available (include 30-60-90-120 day estimates for monthly manufacturing output potential) o What the limiting factors of your ability to scale would be and what can be done to address them (e.g. labor, access to capital, equipment availability, raw material availability, etc.)

- Please provide descriptive information about your supply chain:

o What technologies or suppliers you use to develop and build your test and components o What potential bottlenecks or constraints do you anticipate in your supply chain and what are your recommended solutions or investments that could be made to overcome those constraints?

o The nation of origin for your supplies and suppliers

- Please provide additional information about commercial considerations:

o Your willingness to enter additional partnerships, licensing agreements, or other commercial agreements with alternative manufacturers in order to reach scale as fast as possible o What the nature of those terms would need to be o How the US government can best support your company in sourcing and increasing supplies, components, facilities, and anything else required to scale product

3.0 SPIRAL 1 through 3– Submission Requirements

3.1. All guidance governing the content and evaluation criteria for required submission can be found the below at the following: DAF ACT CSO COVID 19 Response link:

https://beta.sam.gov/opp/a3c11d3423c045f383ef1f0f7628610b/view

3.2. Solutions briefs for this Area of Interest shall be submitted to:

rapidtesting.cso.dafact@afwerx.af.mil

3.3. Once submission is received, every offeror will receive a Response Submission Number via email.

4.0 AoI Open Period –

4.1. Solution Briefs may be submitted immediately upon posting this AOI. Solutions Briefs will be accepted for until 11:59 PM CST on 7 December 2020. This presumes an eight (8) hour work day.

4.2. Evaluations will begin within 48 hours of the posting of this AOI.

Questions concerning this AOI can be sent to the following email:

rapidtesting.cso.dafact@afwerx.af.mil

Purpose of Extension

In an effort to maximize competition, the government will re-open AOI 0001 FA811921SC001 Rapid Point of Care Testing after this posting. That makes the final deadline for submission Monday, December 7, 2020 at 2359 CST. Late submissions will be considered non-responsive and will not be accepted.

If you submitted your brief before the initial deadline, and are satisfied with your submission, you do not have to resubmit your brief. Any briefs submitted since the initial close of the AoI (1600 CST, 1 Dec 2020) and the posting of this revision, however, must be resubmitted for consideration. As the submission process may be new to many offerors, the government would like to clarify the common mistakes discovered throughout the evaluation process.

● Many offerors failed to provide all the information required per CSO paragraph 1.6.2. All information outlined in this section must be present in all brief submissions. Frequent omissions were:

○ Page Limit: 5 for documents and 15 for presentations

○ Business Size

○ Socio-economic status

○ Contact information

○ Date Document

● Moreover, all areas of discussion outlined in section 2 of AoI 0001 FA811921SC001 must also be present within the briefs. Frequent omissions were:

○ The estimated per-test cost (with quantity breakpoints)

○ Your willingness to enter additional partnerships, licensing agreements, or other commercial agreements with alternative manufacturers in order to reach scale as fast as possible

○ What the nature of those terms would need to be

Please ensure your submission is compliant not only with the AoI submission requirements but also within the CSO standards outlined in section 1.6.2. The government thanks you in advance for your participation. Good luck with your forthcoming submissions.

**Companies are advised that any Prototype Other Transaction Agreement (OTA) awarded in response to this Area of Interest may result in the award of a follow-on production contract or transaction without the use of competitive procedures. The follow-on production contact or transaction will be available for use by one or more organizations in the Department of Defense and, as a result, the magnitude of the follow-on production contract or agreement could be significantly larger than that of the prototype OTA. As such, any Prototype Other Transaction Agreement will include the following statement relative to the potential for follow-on production: "In accordance with 10 U.S.C. 2371b(f), and upon a determination that the prototype project for this transaction has been successfully completed, this competitively awarded prototype OTA may result in the award of a follow-on production contract or transaction without the use of competitive procedures.