20200831 JA-COVID-19 Test Sample Type Expansion REDACTED.pdf

Control No: JA-20-08-00193

Contractor: BioFire Defense, LLC Program/Equipment: Sample Type Expansion Studies for the BioFire Defense COVID-19

Test under Emergency Use Authorization

Version – September 2018 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment: The United States Army Medical Materiel Development Activity

(USAMMDA), on behalf of Defense Health Agency (DHA), requires extension of BioFire

Defense’s COVID-19 test to sample types in addition to the single sample type now in use under the Emergency Use Authorization granted by the Food and Drug

Administration (FDA) on March 23, 2020.

Authority: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount: $ 863,843.76

Prepared by:

Contracting Officer:

Technical:

Requirements:

Program/Equipment: Sample Type Expansion Studies for the BioFire Defense COVID-19

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Product Manager:

Signature:

Legal Counsel:

Signature: _

Program/Equipment: Sample Type Expansion Studies for the BioFire Defense COVID-19

FAR Part 6 Justification and Approval for Other than Full and Open Competition

1. Contracting Activity: The contracting activity responsible for this action is the United States Army Medical Research Acquisition Activity (USAMRAA).

2. Description of Action: The DoD seeks to conduct COVID-19 test sample type expansion studies to have the use of the BioFire Defense COVID-19 test expanded beyond the current sample type, which will result in an amendment to BioFire Defense’s Emergency Use Authorization (EUA). The USAMMDA requests a new cost-reimbursement contract with BioFire Defense, LLC, 79 W 4500 S STE 14, Salt Lake City, UT, 84107-2663. The Government projects award for September 2020. Fiscal year 2020 Defense Health Agency (DHA) Research, Development, Test and Equipment (RDTE) 2-year funds will be used.

3. Description of Supplies/Services: Contractor will perform studies to address challenges associated with the sample type now being used for COVID-19 testing.

The recognized challenges are: It is difficult to swab the nasopharynx; the availability of the specialized fluid (viral transport medium) used to store and transport swab samples is questionable; and trained medical personnel are needed to perform nasopharyngeal swabbing. The table below presents the challenges and the approaches to be used in addressing the challenges.

Challenge of current BioFire Defense COVID-19 EUA test:

Approach to be used in this contract to address the challenge:

Limited to use of viral transport medium in short supply (this is a chemically complex medium)

Investigate the use of other media

Limited to testing of nasopharyngeal swab samples (swab deeply into the nose)

Investigate the use of other anatomical sites for sampling by swabs

Collection of samples by trained medical personnel

Investigate the collection of samples by persons other than trained medical personnel

Research and development aimed at improving BioFire Defense’s COVID-19 test by extending its utility to an additional sample type; the current test is limited to nasopharyngeal samples in storage and transport media. The research performed under this effort will ultimately lead to an amendment of the current BioFire Defense COVID-19 test EUA.

Period of Performance: 1 October 2020 to 30 November

2020 Total Value: $863,843.76

Program/Equipment: Sample Type Expansion Studies for the BioFire Defense COVID-19

4. Authority Cited: 10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited: As described at FAR 6.302-1(a)(2), when the supplies or services required by the agency are available only from one responsible source, or for DoD, NASA and the Coast Guard, from only one or a limited number of responsible sources, and no other types of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

The proposed contractor, BioFire Defense, LLC of Murray, Utah, supplies its COVID-19 test to the DoD. The test, which is a consumable, is used as part of a system that includes the FilmArray instrument, a computer, software, and instructions for use, all of which are subject to regulation by the U.S. Food and Drug Administration. There are approximately 1,000 FilmArray instruments in use by the DoD worldwide by all the military services. Hundreds of thousands of BioFire Defense COVID-19 tests have been ordered by the DoD and tens of thousands of tests have already been delivered and put to use under an EUA. BioFire Defense is the only organization with the regulatory standing to submit an amendment to its EUA and amendment is required to further expand COVID-19 testing capabilities. Thus, if the DoD seeks to have the use of the BioFire Defense COVID-19 test expanded beyond the current sample type, the only organization that can meet that requirement is BioFire Defense LLC itself.

If the sample type for COVID-19 testing with the FilmArray is limited to the current type, nasopharyngeal swab specimens in viral transport medium, senior DoD decision makers will be confronted with the following choices:

(A) If they consider the current sample type unsuitable for continued use in COVID- 19 testing with the FilmArray system, because of patient discomfort, the need for trained medical personnel to perform the swabbing, a shortage in viral transport medium, or other factors, discontinue the use of FilmArrays for COVID-19 testing.

Such discontinuation would end the use for COVID-19 testing of assets purchased at considerable expense and require testing to be shifted to other testing platforms. The shifting of COVID-19 testing to other platforms would appear to be both disruptive and costly.

(B) If they consider the continued use of nasopharyngeal swab specimens for COVID-19 testing with the FilmArray system suitable and necessary because there is no alternative sample type available for use under EUA, such use will continue, with attendant burden on people being tested and on health care personnel, reliance on swab supplies, and reliance on supply of viral transport medium.

The investigation of the use of other sample types for COVID-19 testing with the FilmArray system, which will have as its culmination the submission to the Food and Drug Administration (FDA) of an EUA amendment by the only organization that can do so, namely the sole source BioFire Defense, will provide information that may offer

Program/Equipment: Sample Type Expansion Studies for the BioFire Defense COVID-19 another choice: (C) Continue to use FilmArrays with one or more sample types in ways that address the challenges noted for the use of nasopharyngeal swab specimens. The cost of the investigation, estimated at approximately $900,000, appears to be small relative to the costs of alternatives (A) and (B).

As described at FAR 6.302-1(a)(2), when the supplies or services required by the agency are available only from one responsible source, or for DoD, NASA and the Coast Guard, from only one or a limited number of responsible sources, and no other types of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

BioFire Defense owns the proprietary data for its existing COVID-19 test that is currently in use by the DoD. This restricts competition as no other source has access to the proprietary data that is necessary to seek alternative testing measures using BioFire Defense’s unique COVID-19 test.

COVID-19 is a national emergency. If alternate testing is not discovered using various types of samples there could be a loss in life as the measures required to expand testing capabilities will be delayed.

6. Efforts to Obtain Competition: A sources sought notice was issued along with a notice of intent to sole source and no responses were received from capable sources.

a. Effective Competition: Because this is a sole source action, effective competition is not applicable.

b. Subcontracting Competition: There are no competitive subcontracting opportunities for this requirement. The requirement will be performed by BioFire Defense, LLC.

7. Actions to Increase Competition: There are no actions that can be taken to increase future competition as BioFire Defense is the owner of proprietary data related to its COVID-19 test.

8. Market Research: Market research was conducted from 8 April 2020 through 17 August 2020 by the requiring activity. The goal of market research was identification of one or more business organizations with the following characteristics: (1) It markets a COVID-19 test under EUA; (2) Its test can detect SARS-CoV-2 nucleic acid at sensitivity and specificity likely to be high because of the technology employed in testing; (3) Its test results are available within a few minutes to a few hours after a specimen is placed on test; (4) Its test is either a stand-alone test not requiring instrumentation or a test that is used in conjunction with a system already in use by the DoD; and (5) It has the capability to perform the sample type expansion studies needed to yield relevant data for amendment of its EUA.

The FDA’s website, with the link provided below, was the starting point of market research.

Program/Equipment: Sample Type Expansion Studies for the BioFire Defense COVID-19 https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency- use-authorizations-medical-devices/vitro-diagnostics-euas#individual-molecular

BioFire Defense LLC is the only organization with the regulatory standing with the FDA to submit an EUA amendment to make its COVID-19 usable with specimens other than nasopharyngeal swab specimens. Additionally, as described above in paragraph 5, since the BioFire FilmArray system is already widely deployed across the DoD, it would be more expensive and time consuming to pursue the same objectives using another diagnostic test on the market that also has EUA.

In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a sources sought was posted to Beta SAM at https://beta.sam.gov/ on 3 Aug 2020 with closing date of 18 Aug 2020 and the results were that no other capable sources responded.

To date, there are no other sources known to be capable of meeting this requirement (see Section 8). One company, SteriPack USA, responded to the sources sought notice on 7 Aug 2020 but did not express interest in the requirement synopsized or provide a capability statement. The company only provided information related to swabs it could provide as a material item, but did not say they can perform studies and submit information to the FDA that would lead to expansion of sample type for BioFire Defense's COVID-19 test. The requiring activity reviewed this response on 14 Aug 2020 and concurred that SteriPack USA was not capable of meeting the requirement.

As shown in the market research, interest is limited as no known sources can provide the required service within the required timeframes to meet the needs of the Government in order to protect public health in a timely manner.

9. Interested Sources: As indicated during market research (see Section 8), one source responded but was not capable of satisfying the Government's requirement based its limitation of furnishing only swabs for testing. IAW FAR 5.201, a notice of intent to sole source was posted on 17 Aug 2020 and closed on 24 Aug 2020. No responses were received in response to the notice to intent to sole source.

10. Other Facts:

a. Procurement History: N/A (new requirement)

b. Other facts: N/A http://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-http://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-https://beta.sam.gov/

Program/Equipment: Sample Type Expansion Studies for the BioFire Defense COVID-19

11. Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

12. Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Program/Equipment: Sample Type Expansion Studies for the BioFire Defense COVID-19

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: ☒ cost analysis ☐ price analysis

☐ should cost ☒ IGCE ☐ audit: ☐ other:

As a part of this basis, certified cost or pricing data:

☐ will be required.

☒ will not be required and the following exception applies (FAR 15.403):

☐ Prices that will be agreed upon are based on adequate price competition.

☐ Prices that will be agreed upon are based on prices set by law or regulation.

☐ A commercial item is being acquired.

☐ A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

☐ The contract action is a modification to a contract or subcontract for commercial item(s).

☒ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Program/Equipment: Sample Type Expansion Studies for the BioFire Defense COVID-19

Approval

Based on the foregoing justification, I hereby approve the procurement of Sample

Type Expansion Studies for the BioFire Defense COVID-19 Test under Emergency

Use Authorization for the estimated amount of $863,843.76 on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1) Only One

Responsible Source and No Other Supplies or Services Will Satisfy Agency

Requirements, subject to availability of funds, and provided that the services or property herein described have otherwise been authorized for acquisition.