Justification and Approval 20200501 FAR 6_302-2 COVID19 test 510K Redact..__Redacted 6-23-20.pdf

Control Number: JA-20-04-0310

BioFire Defense COVID-19 Test 510(k) with Sample Expansion Option

For Official Use Only (See FAR 2.101 and 3.104-4)

(March 2020)

Justification and Approval FAR 6.302-2 Other than Full and Open Competition

Urgent and Compelling for COVID-19

1. Contracting Activity: The contracting activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA).

2. Description of Action: This approval is for a new contract. It is a cost-reimbursement contract. It is funded with Research, Development, Test and Evaluation funding.

3. Description of Supplies/Services: Research and development aimed at securing FDA 510(k) clearance under the Federal Food, Drug, and Cosmetic Act for BioFire Defense’s COVID-19 test. The estimated total value is .

Period of Performance: May 2020 to May 2021. Total Value: .

Optional Item: 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. Period of Performance: May 2020 to November 2020. Total Value:

4. Authority Cited: 10 U.S.C. 2304(c)(2), as implemented by FAR 6.302-2, Unusual and compelling urgency.

5. Reason for Authority Cited:

41 U.S.C. 1903 Special Emergency Procurement authority is authorized because the President of the United States made an emergency determination under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121- 5207 (the "Stafford Act") in response to the COVID-19 pandemic on 13 March 2020.

The U.S. Army Medical Materiel Development Activity (USAMMDA) Warfighter Protection and Acute Care (WPAC) Project Management Office has a public responsibility to comply with the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) guidance to prevent further spread of COVID-

19. They are also required to comply with Department of Defense (DoD) and U.S. Army Europe guidance to implement plans to ensure compliance with directed force health protection measures throughout the area of operations in order to prevent an outbreak of COVID-19 within U.S. personnel (service members, civilians, contractors, and dependents) or confine it to as small a population as possible. In order to comply and put protective measures in place, USAMMDA WPAC has an urgent need for research and development aimed at securing U.S. Food and Drug Administration (FDA) approval in the form of 510(k) clearance for BioFire Defense’s COVID-19 test, which attained Emergency Use Authorization (EUA) on March 23, 2020. While EUA authorization permits this COVID-19 test to be used during the period of a declared emergency, it will expire when the emergency comes to an end, at which point the test could no longer be used as an aid to diagnosis. If that were to happen, DoD users would need to use another COVID-19 test, necessitating additional decision-making by acquisition and other personnel. These services are required in order to protect the public from the spread of (or isolate people infected with) COVID-19. This requirement will supply the FDA with the assay performance data needed to satisfy the stringent criteria for 510(k) clearance, a form of marketing approval; under the current Emergency Use Authorization, the FDA stated on March 23, 2020 in its response to BioFire Defense’s request for Emergency Use Authorization that, “it is reasonable to believe that your product may be effective in diagnosing COVID-19.” The FDA’s clearance under section 510(k) would mean that the COVID-19 test has been shown to be effective, providing meaningful assurance to physicians and other medical and public health authorities. In addition to the 510(k) clearance, this requirement will improve the COVID-19 test by expanding its use in one of three ways: (a) Expanding its use to enable detection of virus at additional anatomical sites sampled by swabbing; (b) Expanding its use to enable detection of virus in a saliva sample, a sample that can be obtained without the use of trained medical personnel; or (c) Expanding its use to additional types of fluid media for storage and transport of samples. BioFire Defense will perform studies to determine which of the additional anatomical sites (nose or throat swabs, or saliva samples), and, in the case of swabs, transport media, is associated with the highest sensitivity and specificity of detection. This improvement will address one or more of the limitations noted by personnel involved in responding to the COVID-19 emergency, namely the difficulty of reaching certain swab sites, shortages in fluid media used for sample storage and transport, and the need for the use of trained medical personnel to obtain swab samples.

It should be noted that BioFire Defense developed its COVID-19 test as a delivery order under contract W911QY-13-D-0080, which was issued on February 28, 2013 in response to a competed solicitation. BioFire Defense’s COVID-19 test was developed in response to a government requirement aimed at securing a COVID-19 test as rapidly as possible. While the issued Indefinite Delivery/Indefinite Quantity contract could be used to obtain 510(k) clearance for the COVID-19 test, there is a dollar value ceiling for that contract and a considerable risk that the value of this effort, and other COVID-19 efforts, including procurement of end items, would cause that ceiling to be reached. Thus, it is necessary to issue a new contract, the subject of this Justification.

Every day that passes confirmed COVID-19 cases spike and the death toll increases. It is imperative that research and development aimed at 510(k) clearance for BioFire Defense’s COVID-19 test is obtained as quickly as possible to protect public health. The U.S. Government cannot apply standard procurement times to an acquisition of this urgent nature. Even the short time-lines of 30-60 days to award could result in hundreds of thousands more being infected and thousands more dying.

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 positive and negative external controls. There are 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 have been delivered and used. BioFire Defense is the only organization that could submit a request for 510(k) clearance for its COVID-19 test. Also, improvements to BioFire Defense’s COVID-19 test can only be made by BioFire Defense as part of a supplement/amendment to its Emergency Use Authorization; no other organization can make those improvements.

BioFire Defense is well-positioned to address the challenge of developing a 510(k) submission to the FDA; it did not do so earlier because the government under the ‘0080 contract required very rapid development for Emergency Use Authorization. There is an urgent and compelling need to advance the regulatory status of the COVID-19 test so that (1) it can be used whether or not the period of declared emergency is in effect, (2) it is not in an inferior status with respect to other tests that may advance to 510(k) clearance status, and (3) the medical community has available to it the body of information that will be developed from the studies required to earn 510(k) clearance.

The government requires the 510(k) clearance to be achieved as soon as possible. It is believed that BioFire Defense can submit its 510(k) clearance application within approximately eight months of contract award; following that submission, FDA action will be needed to achieve 510(k) clearance. The time required for FDA action on the application will depend on FDA workload and the status of its workforce, the quality of BioFire Defense’s submission, and possibly other factors. The work toward 510(k) clearance is needed so that DoD can have the capability to use an FDA-cleared COVID-19 in the BioFire FilmArray® instruments in its possession.

The improvements to be addressed by this contract will respond to problems widely reported, namely the challenges of swabbing the nasopharynx; shortages in the availability of specialized fluids used to store and transport swab samples; and the fact that trained medical personnel are needed to obtain swab samples. The table below presents the challenges and 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 sample storage and transport media in

Investigate the use of saline and phosphate buffered saline (these are widely available and short supply (these are chemically complex media) can be readily prepared in a testing facility)

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

Investigate the use of nose and throat swabs (no need to reach far into the nose or throat)

Collection of samples by trained medical personnel

Investigate the use of saliva samples, a form of self-sampling that does not require the use of medical personnel

The challenges listed above are real-world challenges amply documented and widely known. They impose constraints on testing for SARS-CoV-2, the virus that causes COVID-19, thereby limiting the government’s ability to respond to this emergency. Now that the test has been developed and challenges have been recognized, there is an urgent and compelling need to deal with them by putting this company’s resources to work on addressing the challenges. The investigations to be done by BioFire Defense will yield results that will inform the selection of an additional sample type for use with the COVID-19 test. The government requires these investigations pertaining to test improvement to be delivered as soon as possible. It is believed that BioFire Defense can deliver them within approximately six months of contract award.

While it is possible that other organizations (government or industry) could perform the studies needed for 510(k) clearance and the testing improvements, the time required to identify such organizations would delay the introduction of the required testing improvements. Furthermore, as previously noted, BioFire Defense is the only organization with the regulatory standing to make a 510(k) submission for its COVID-19 test. BioFire is also the only organization with the regulatory standing to improve its COVID-19 test. Delays are not acceptable in the context of a virus that is circulating in many states, territories, and nations, and can be expected to do so until a vaccine is available. Testing for SARS-CoV-2 allows other public health measures, such as isolation of infected people, to be used until immunization is available to prevent disease.

6. Efforts to Obtain Competition: BioFire Defense is the only organization with the regulatory standing with the FDA to make a 510(k) submission or to improve its FDA-regulated test, any thus any effort to solicit offers from other sources would be irrational and futile. The exception in FAR 5.202(a)(2) to notices otherwise required by FAR 5.201 applies to this contract.

7. Actions to Increase Competition: In 2013, the Department of Defense awarded a contract on a competitive basis to BioFire Defense to develop and supply tests for a large number of biological agents. It was within that contract that BioFire Defense developed its COVID-19 test. Leaders can consider cost, schedule, and performance trades when they select the types of tests to acquire (for example, tests to detect coronavirus nucleic acids, tests to detect coronavirus proteins, tests to detect human responses to coronavirus infections; the type of environment/level of care in which testing is to be performed; and whether testing is for the purpose of aiding diagnosis or for other purposes). The selection of type of test to acquire is a form of competition.

Once a type of test is selected for acquisition, leaders can decide whether, in view of time or other constraints, acquisition should be done in a competitive manner. Given the general preference for competition embodied in acquisition regulations, it can be expected that the question of competition will be decided in a thoughtful, informed manner.

Currently, the existing time constraints posed by the COVID-19 pandemic render the Government unable to pursue other opportunities to increase competition. The nature of the emergency response required to save lives means time spent attempting to increase competition would not be in the best interest of the Government or the greater public at large.

8. Market Research:

Market research was conducted from 8 April 2020 through 15 April 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 Emergency Use Authorization; (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 type of studies needed to yield the data for inclusion in a 510(k) submission.

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

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd

Market research revealed that BioFire Defense satisfies the search criteria.

In December of 2019 an outbreak of COVID-19 was reported in Wuhan City, Hubei Province, China. The World Health Organization (WHO) states COVID-19 is the infectious disease caused by the most recently discovered coronavirus. They also state in humans, several coronaviruses are known to cause respiratory infections, ranging from the common cold to more severe diseases, such as COVID-19. The WHO states:

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd

“Around 1 out of every 6 people who gets COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high blood pressure, heart problems or diabetes, are more likely to develop serious illness.

People with fever, cough and difficulty breathing should seek medical attention.”

The WHO declared the global COVID-19 outbreak a pandemic on 11 March 2020, stating it is a “public health crisis”. The following is information from the WHO website.

The WHO is recommending all countries activate and scale up their emergency response mechanisms utilizing a four-pronged approach. First, prepare and be ready. In other words, prepare your people and your health facilities. Second, detect, prevent, and treat. Utilize surveillance to find, isolate, test and treat every case in order to break the chain of transmission. Third, reduce and suppress. Reduce transmission by finding and isolating as many cases as possible and quarantining their closes contacts. Protect health facilities, old age homes, and other vital areas. They recommend testing all suspected cases. Fourth, innovate and improve. Find new ways to prevent infection, save lives, and minimize impact. Utilize personal protective equipment. Utilize the WHO training programs, technical guidance, studies, protocols, and preparedness and response plans.

The research and development aimed at securing 510(k) clearance for BioFire Defense’s COVID-19 test fits into the “detect, prevent, and treat” prong by finding/testing every case with a high degree of confidence in test results, whether positive for negative for virus. It also fits into the “reduce and suppress” prong by finding as many cases as possible, enabling isolation and quarantine. Similarly, improvement of the COVID-19 test by expansion to an additional sample type will fit into both prongs; it will address the challenges experienced in obtaining nasopharyngeal swab sample, the shortage of transport media, and the need for special personnel to obtain samples.

On January 31, 2020, the United States Department of Health and Human Services Secretary Alex M. Azar II declared a public health emergency (PHE) for the United States to aid the nation’s health care community in responding to COVID-19. On 13 March 2020, the President of the United States of America declared COVID-19 an emergency IAW 42 U.S.C. 5122 (the Robert T. Stafford Disaster Relief and Emergency Assistance Act) which allows for Special Emergency Procurement Authority IAW 41 U.S.C.1903. On 18 March 2020, the President invoked his authority IAW the Defense Production Act. The Act allows the President, where necessary to promote the national defense, may require acceptance and performance of contracts orders by any person he finds to be capable of performing them.

Based on the guidance issued by the WHO, CDC, U.S. Government organizations, and other State Departments throughout the world, people are stocking up on supplies needed to maintain health and to enable diagnosis of COVID-19, including supplies such as swabs and fluid media for storage and transport of swab samples, so there is a worldwide shortage of some required supplies. This contracting action supports DoD response by securing continued to access to a COVID-19 test that can be used in the face of shortages of some supplies.

9. Interested Sources: As shown in the market research, interest is limited as many sources cannot provide the required quantities of the service within the required timeframes to meet the needs of the Government in order to protect public health in a timely manner.

10. Other Facts:

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

b. Other facts: N/A

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.

Signature:

Typed Name: Title:

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.

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for determination: Costs will be determined fair and reasonable based upon cost analysis techniques described at FAR 15.404-1(c), including verification of cost data and evaluation of cost elements, as well as comparison of costs proposed by the offeror with previous cost estimates from the offeror for similar services and independent government cost estimates by technical personnel. Certified cost or pricing data will be required in accordance with FAR 15.403-4.

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Approval Based on the foregoing justification, I hereby approve the procurement of BioFire Deense COVID-19 Test 510(K) with Sample Expansion Option on an other than full and open competition basis pursuant to the authority of 10 U.S.C.2304(c)(2) Unusual and Compelling Urgency, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.