Supporting Evidence cobas 4800_Sole Source Letter_.pdf
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- Attached to
- Roche Diagnostics cobas® 4800 and cobas® 6800
- Solicitation number
- 2026-Q-98331
About this file
This is a vendor justification letter from Roche Molecular Systems Team supporting sole source procurement of the cobas® 4800 System for the CDC. The letter establishes that the cobas® 4800 System is a fully-automated in vitro diagnostic (IVD) platform distributed and serviced exclusively through Roche Molecular Diagnostics in the United States, with Roche as the sole manufacturer and distributor for all compatible assays.
The document details unique system capabilities including full automation with software-driven, bar-coded reagents; processing throughput of up to 96 results in 4.3 hours, 192 results in approximately 8 hours, or 288 results overnight using the CTNG protocol; mixed-run capability for HSV, MRSA/SA, and Cdiff assays; and real-time PCR detection using five optical channels. The system performs FDA-approved/cleared tests including cobas® HPV, CTNG v2.0, HSV 1 and 2, Cdiff, MRSA/SA, and mutation detection assays (BRAF V600, EGFR, KRAS, EZH2). Key design features include bi-directional Laboratory Information System (LIS) communication to eliminate manual data entry and user-defined workflow capability on the cobas z480 analyzer. The letter emphasizes contamination prevention through proprietary technologies: AmpErase® Enzyme, CO-RE tip technology, Total Aspirate and Dispense Monitoring (TADM), Smart-Path Pipetting, Anti-droplet Control (ADC), and an air displacement system that eliminates the need for bleach decontamination, thereby reducing daily maintenance burden and maximizing laboratory throughput.
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1References: cobasⓇ 4800 System Operators Manuals (Assay Specific) .
June 26th, 2025
CDC
The Roche Molecular Systems Team would like to provide the following information to support your sole source justification of the cobas® 4800 System and respective assays.
The cobas® 4800 System is a fully-automated IVD platform which is only distributed and serviced through Roche Molecular Diagnostics in the United States. Roche is also the sole manufacturer and distributor for all assays performed on this system, in the United States.
The cobas® 4800 System was designed to minimize contamination with several multi-layered controls described in the Safety Features and Contamination Prevention section below. This provides laboratories with the ability to confidently run FDA-approved/cleared Real-Time PCR tests including:
● cobas® HPV test
● cobas® CTNG v2.0 test
● cobas® HSV 1 and 2 test
● cobas® Cdiff test
● cobas® MRSA/SA test
● cobas® BRAF V600 Mutation test
● cobas® EGFR Mutation test
● cobas® KRAS Mutation test
● cobas® EZH2 Mutation test
● cobas® Factor II/Factor V test
The following features are unique to the cobas® 4800 System1:
Design
● Full Automation: software driven, ready-to-use bar-coded, room temperature reagents
● Throughput (CTNG protocol): up to 96 results in 4.3 hrs, 192 results in ~8 hrs, 288 results overnight
● Accepts mixed runs for HSV, MRSA/SA, and Cdiff
● Requires least amount of hands-on time per run (Argent data on file)
● Real time PCR using 5 optical channels: Detects multiple targets from 1 reaction tube
● Designed for bi-directional LIS communication: Simplifies test ordering while supporting integrity of results
(no manual data entry required)
● Open channel capability (User Defined Workflow) on the cobas z480 analyzer
Safety Features and Contamination Prevention
1References: cobasⓇ 4800 System Operators Manuals (Assay Specific) .
● AmpEraseⓇ Enzyme: Used in every cobas® 4800 System assay. Reduces the risk of false positive results from carry over contamination by differentiating amplified products from target molecules
● CO-RE tip technology: Prevents cross-contamination by securely locking pipette tips in place to avoid motions that could create aerosols of samples/reagents
● Total Aspirate and Dispense Monitoring (TADM): Ensures valid results by monitoring the pressure within tips to detect low volumes and clots; pressure responses that fall outside the expected range are reported as errors
● Smart-Path Pipetting ensures that during pipetting steps, the system moves samples around other samples, reagents, and processing plates; samples are not carried over other samples during processing
● Anti-droplet Control (ADC): The cobas® 4800 System automatically compensates for reagent vapor in the pipette tip by continually monitoring the pressure and adding vacuum to the tip when needed
● Air displacement system eliminates the need for large batches of wash buffer, system priming, and the disposal of large volumes of liquid waste
By utilizing the Contamination Prevention features above, the cobas® 4800 System does not require any decontamination with bleach. This allows for minimal daily maintenance and maximum throughput for your lab.
We thank you for your support, continued use of our products, and are glad to provide additional details, should you desire.
Sincerely, Roche Diagnostics Molecular Systems Team
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