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Roche launches automated vertical transportation for lab samples

November 2023—Roche announced last month the U.S. launch of its Cobas Connection Modules (CCM) Vertical, the elevator and overhead components of its fully automated and modular CCM system to help low-, mid-, and high-volume laboratories optimize space, productivity, and patient care.

“The CCM Vertical is the only laboratory conveyor system in the U.S. that moves samples up and down without reducing overall track speed, throughput, or turnaround times,” Brad Moore, president and CEO of Roche Diagnostics North America, said in a news release.

The CCM Vertical includes elevator units (adjustable walk-through height of 1.87–2.24 meters), overhead conveyors, and overhead turn units that integrate with Roche’s other CCM solutions. This Cobas solution helps simplify laboratory operations, Roche says, by transporting patient samples hands-free in every direction—up, down, across, and between rooms; around doorways, emergency exits, and walkways; and through walls, ceilings, and floors.

The first CCM Vertical implementation in the U.S. is scheduled to go live at Vanderbilt University Medical Center in early 2024.

AMP publishes recommendations for cfDNA assay validation

The Association for Molecular Pathology last month issued 13 best-practice recommendations for validating and reporting clinical circulating tumor DNA assays and the related scientific publications (https://bit.ly/jmoldx-100623).

The AMP clinical practice committee’s liquid biopsy working group, with representatives from the CAP and American Society of Clinical Oncology, based its recommendations on a review of 1,228 publications that describe ctDNA assay performance in patients with lymphoma and solid tumor malignancies and on subject matter expert professional experience. The 13 recommendations are part of a joint consensus AMP-CAP recommendation.

The seven testing-related recommendations say that laboratories should do the following during validation:

• Define and describe the medical indication for an assay, including the clinical scenarios to which the performance characteristics apply and the methods used.
• Define and describe clinical assay performance characteristics appropriate for the medical indication for the test.
• Evaluate and describe key clinical assay performance characteristics on an individual variant basis, but these may be aggregated for each variant class.
• Define and describe the analytical sensitivity of the assay for each variant and/or variant class.
• Define and describe in vivo and in vitro potential sources of assay interference.
• Evaluate and address in vivo and in vitro potential sources of result interpretation error.
• Define and describe orthogonal method confirmations.

Five of the recommendations are related to reporting, among them that it should describe preanalytical variables pertinent to pathologist and clinician understanding of reported results—for example, volume and type of collected fluid and storage and processing details. The publication-related recommendation says publications that describe ctDNA assays intended for clinical applications, including description of clinical validation, should include key performance characteristics.

FDA issues guidance on updating breakpoints in AST device labeling

The FDA in late September issued guidance for industry and FDA staff on antimicrobial susceptibility test system devices—updating breakpoints in device labeling (https://bit.ly/FDAguide-AST). The FDA says the guidance is expected to facilitate the timely adoption of updated breakpoints in antimicrobial susceptibility test system devices to help ensure device safety and effectiveness.