5999-0 2024 BFR0001-7529 Sole Source Customer Letter All bMx Products (8).pdf

To Whom It May Concern:

This letter is to confirm that bioMérieux, Inc. is the sole source manufacturer and service provider of the systems and software listed below with exception of BIOFIRE® products. bioMérieux’s wholly owned subsidiary, BioFire, Diagnostics, LLC is the sole source manufacturer and service provider of the BIOFIRE products listed below. All bioMérieux Field Service Engineers are certified and qualified with extensive factory training and experience in working on the entire range of bioMérieux products. If any unauthorized third-party repairs, alters or modifies a bioMérieux instrument or the operative software, bioMérieux is not responsible for defects arising from such repair or modifications.

BIOFIRE® FILMARRAY® TORCH System and the BIOFIRE® FILMARRAY® 2.0 System and associated reagents

{ The BIOFIRE® FILMARRAY® TORCH System and BIOFIRE® FILMARRAY® 2.0 System are an automated, user-friendly platforms that run multiplex PCR diagnostic tests that span a variety of syndromes. Together, these BIOFIRE Systems and tests create a solution that delivers integrated sample preparation, amplification, detection, and analysis from one sample, and detects multiple pathogen targets. The results from these tests are available in about an hour depending on the the test. The BIOFIRE® TORCH and BIOFIRE® 2.0 Systems are compatible with the following FDA-cleared panels:

• BIOFIRE® Respiratory 2.1 Panel

• BIOFIRE® FILMARRAY® Gastrointestinal Panel

• BIOFIRE® Blood Culture Identification 2 Panel

• BIOFIRE® FILMARRAY® Meningitis/Encephalitis Panel

• BIOFIRE® FILMARRAY® Pneumonia Panel

• BIOFIRE® Joint Infection Panel

BIOFIRE® SPOTFIRE® System and associated reagents

{ The BIOFIRE® SPOTFIRE® System is an automated, user-friendly platform that run two CLIA-waived respiratory multiplex PCR diagnostic tests . Together, the SPOTFIRE Systems and tests create a solution that deliver integrated sample preparation, amplification, detection, and analysis from one sample, and detects multiple pathogen targets. The results from these tests are available in about 15 minutes.

{ BIOFIRE® SPOTFIRE® Respiratory Panel

{ BIOFIRE® SPOTFIRE® Respiratory/Sore Throat Panel

{ BIOFIRE® SPOTFIRE® Respiratory Panel Mini

BIOFIRE® FILMARRAY® 2.0 EZ

{ This system configuration runs the BIOFIRE® Respiratory 2.1-EZ Panel (EUA)*

CLARION™

{ CLARION is a secure, cloud-based clinical informatics software-as-a-service that connects and integrates disparate data into a single management application. CLARION gives a holistic view of relevant lab and clinical data across departments, processes, and vendors, and translates this data into actionable insights visualized on easy-to-use dashboards.

MAESTRIA™

{ MAESTRIA is a laboratory microbiology middleware solution. That connects all bioMérieux microbiology instrumentation into a single data management platform.

FIREWORKS™

{ FIREWORKS provides a centralized location of your BIOFIRE® System data. It helps manage and deliver complete insights into: system performance and optimization, fleet management and utilization, pathogen surveillance and laboratory workflow management. FIREWORKS provides comprehensive insight into any BIOFIRE Panel. All customer data are encrypted in transit and at rest in our cloud database hosted by Amazon Web Services (AWS).

VITEK® MS PRIME and VITEK® MS

{ A mass spectrometry system using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens.

The system is comprised of the VITEK MS analyzer, Maestria microbiology middleware, and reagent consumables.

VITEK® 2 XL, VITEK® 2 60, VITEK® 2 60, VITEK® 2 COMPACT 60, VITEK® 2 COMPACT 30, and VITEK® 2 COMPACT 15

{ A reliable, rapid, and easy automated system for providing bacterial identification and/or antimicrobial susceptibility testing when used with the following associated reagents:

ETEST®

{ A quantitative technique for determining the antimicrobial susceptibility of Gram-negative bacteria, Gram positive bacteria, fastidious bacteria, and yeasts. The system is comprised of a predefined antibiotic gradient that is used to determine the Minimum Inhibitory Concentration (MIC), in μg/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation.

API®

{ A method for microorganism identification to the species level. The test kits contain strips with microtubes of biochemical tests. During incubation, organism metabolism produces color changes in the microtubes.

The reactions are interpreted according to the reading tables and an identification is obtained using APIWEB™. APIWEB is an Internet-based platform containing all API databases for a reliable interpretation of API strip results.

NUCLISENS® EMAG®/easyMAG® instruments

{ Automated nucleic acid extraction systems capable of processing various sample types and volumes within the same run using a single standardized workflow.

EPISEQ®

{ EPISEQ is a cloud based, software as a service (SaaS) with a fully automated bio-informatics pipeline for the analysis of next generation sequencing (NGS) data. Current applications of EPISEQ include whole genome analysis for bacterial strain typing and variant calling for SARS-CoV-2 viral sequences. The software is comprised of an intuitive user interface and pre-paid credits for data uploads.

BACT/ALERT® VIRTUO® and BACT/ALERT® 3D and BACT/ALERT® culture bottles

{ BACT/ALERT is a continuous monitoring blood culture system to be used with BACT/ALERT culture bottles.

These bottles contain liquid culture media for recovery of microorganisms from blood and/or sterile body fluids. The BACT/ALERT MP Reagent System provides a microbial detection system and culture media for the recovery of mycobacterial species commonly isolated from patient specimens other than blood.

CHROMID® Chromogenic Culture Media

{ CHROMID is an extensive range of chromogenic media for the simultaneous culture and identification of microorganisms in clinical specimens. Specific chromogenic substrates are included in the agar along with peptones and, if needed, antibiotics. The substrate is hydrolyzed when it comes in contact with the bacteria or yeast, resulting in specific coloration for clear identification. The intensity and specificity of the colors of CHROMID make results clear to see.

PREVI® COLOR GRAM

{ PREVI COLOR GRAM is an automated Gram staining system that utilizes patented spray technology to provide rapid, standardized results for all types of specimens while adding efficiency to the microbiology process species commonly isolated from patient specimens other than blood.

VIDAS®

{ The VIDAS family instruments, including VIDAS 3, MINI VIDAS, and VIDAS, are automated benchtop immunoassay systems that utilize proven enzyme-linked fluorescent assay (ELFA) technology, for high quality, on-demand test results. A specialized menu is offered, providing single-test reagents that are ready to use.

For all United States Department of Veterans Affairs and State Public Health Laboratory customers as well as all other customers which are part of the United States Government including, without limitation, the Department of Defense and its agencies; the Departments of State, Commerce, Treasury, Transportation, Interior, Agriculture, Labor, Justice, Education, Health and Human Services, and Homeland Security; the National Aeronautics and Space Administration; the General Services Administration; the Small Business Administration; the National Science Foundation; the Environmental Protection Agency; the United States Agency for International Development; the Federal Reserve System; the Nuclear Regulatory Commission; the United States International Trade Commission; the United States Trade Representative; the Federal Communications Commission; and the Government Accountability Office U.S., The BIOFIRE products are only available through bioMérieux, Inc.

in the USA.

If you need additional information, please feel free to email us at us.servicecontracts@biomerieux.com.

Sincerely, BFR0001-7529-03

Stijn Bammens Vice President of Clinical Marketing, North America

*This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.

*This product has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms.

*The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for de-tection and/ or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.