BIOFIRE Defense, LLC Test Kits and Reagents

BIOFIRE® Defense, LLC Test Kits and Reagents Product Service Code: 6550- In Vitro Diagnostic Substances, Reagents, Test Kits And Sets NAICS Code: 325413- In-Vitro Diagnostic Substance Manufacturing-(Small Business Size Standards 1,250 Average Number of Employees)

Place of Performance:

Bethesda, MD 20892 POTS:

25-000958-1 Description: This is a notice of intent, not a request for a quotation. A solicitation document will not be issued, and quotations will not be requested.

The National Institutes of Health, Clinical Center, Office of Purchasing and Contracts on behalf of the Department of Laboratory Medicine intends to award a fixed price contract to BioFire Defense, LLC located at 75 West 4500 South, Suite 14 in Salt Lake City, Utah 84107 to provide BIOFIRE® Reagent Kits for a base period and four option years to be exercised at the government’s discretion. The Department of Laboratory Medicine serves as the clinical laboratory of the National Institutes of Health, Clinical Center.

It provides laboratory support for patient care; research protocols and performs research and training in disciplines of Clinical Pathology. The Department of Laboratory Medicine owns BIOFIRE® analyzers and requires BioFire test kits and reagents in support of patient care. The BioFire test kits are used for detecting pathogens in various patient specimens, specifically the blood, CSF, stool, and respiratory samples.

They are rapid tests that allow for results to be attain within an hour, which in turn allows for clinicians to be able to immediately institute treatment to impacted patients if any of the testing comes back positive for infection. BioFire Defense, LLC is the sole manufacturer and only distributor of its equipment, reagents, and test kits. BioFire Defense, LLC does not have any distributors, dealers of record, or authorized resellers.

BioFire Defense, LLC is the only source that can supply the required proprietary test kits and reagents compatible with the government owned BIOFIRE® analyzers BIOFIRE® FilmArray 2.0 and BIOFIRE® TORCH systems. Other manufacturer test kits and reagents are not compatible with the BIOFIRE® analyzer. If other manufacturer reagents are used, it may cause damage to the equipment and cause erroneous test reports which in turn will negatively impact patient care.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1). For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

Interested Parties: Interested parties capable of providing the same or similar products or services described in this notice may submit a capability statement outlining their capability to perform the described work. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. The determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Comments: Comments to this announcement, referencing this posting number on the email subject line, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri, Contract Specialist, sheri.eiri.nih.gov by the due date November 17, 2024, 12:00 pm Noon EST and time marked in this notice. No phone calls will be accepted.