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

The U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the U.S. Army Medical Materiel Development Activity (USAMMDA) intends to issue a Cost Plus Fixed Fee (CPFF), Sole Source, contract to BioFire Defense, LLC, DUNS: 556915205, in accordance with statute 10 U.S.C 2304(c)(1) as implemented in Federal Acquisition Regulation (FAR) Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

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, 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 Emergency Use Authorization (EUA). BioFire Defense is the only organization with the regulatory standing to submit an amendment to its EUA. 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.

The U.S Army Medical Material Development Activity (USAMMDA) has a requirement for sample type expansion studies for the BioFire Defense COVID-19 test under EUA.  The overall objective is to increase the utility of the BioFire COVID-19 test system.

Sample Type A Studies:  Anterior Nares Swab Sample in viral transport medium and one other medium (sterile saline, for example)

Sample Type B Studies:  Saliva Sample, using the Spectrum Solutions SDNA-1000 Saliva Collection Device and alternative saliva collection method. Test saliva samples from individuals suspected of COVID-19 by their healthcare provider.

The required period of performance is two (2) months (1 Oct 2020 – 30 Nov 2020).

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES and a written solicitation will not be issued. This announcement constitutes the only notice by the government; however any interested concern that believes it can meet the requirement must respond in writing in the form of a capability statement. Responses must include supporting evidence that is clear and concise which articulates the ability to comply with the requirement outlined above. A request for documentation will not be considered an affirmative response. A determination by the Government not to compete this procurement on a full and open competitive basis will be made based on the responses received. Determination is solely within the discretion of the Government. If no written responses are received by the date listed below, the proposed contract modification will be awarded without further remark.

Interested concerns must identify their capability in writing via email to Ms. Dana Kavitski at dana.kavitski.civ@mail.mil no later than 4:00 pm ET, August 18, 2020. All questions and responses concerning this notice shall be emailed to Ms. Dana Kavitski at dana.kavitski.civ@mail.mil. Telephone inquiries will not be answered.