Sample processing module array handling system and methods
Inventors
Chang, Ronald • Montgomery, Steven • Mote, Gregory • Bliven, Brian
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Assignees
Member
CepheidCepheid is a global leader in molecular diagnostics, dedicated to improving healthcare by developing, manufacturing, and marketing automated, easy-to-use molecular systems and tests. Their mission is to provide rapid, accurate, and actionable genetic testing for a wide range of infectious diseases, oncology, and human genetics. Cepheid's flagship GeneXpert System delivers scalable, sample-to-answer PCR testing for institutions of any size, supporting both centralized and decentralized care. The company is committed to expanding access to high-quality diagnostics worldwide, supporting public health initiatives, driving innovation in molecular testing, and advancing sustainability and responsible business practices.
Cepheid is a global leader in molecular diagnostics, dedicated to improving healthcare by developing, manufacturing, and marketing automated, easy-to-use molecular systems and tests. Their mission is to provide rapid, accurate, and actionable genetic testing for a wide range of infectious diseases, oncology, and human genetics. Cepheid's flagship GeneXpert System delivers scalable, sample-to-answer PCR testing for institutions of any size, supporting both centralized and decentralized care. The company is committed to expanding access to high-quality diagnostics worldwide, supporting public health initiatives, driving innovation in molecular testing, and advancing sustainability and responsible business practices.
Publication Number
US-12235279-B2
Publication Date
2025-02-25
Expiration Date
Abstract
A handling system for high throughput processing of a large volume of biological samples is provided herein. Such systems can include an array support assembly that supports multiple diagnostic assay modules in an array having at least two dimensions, a loader that loads multiple diagnostic assay cartridges within the multiple diagnostic assay modules. The array support assembly can be movable relative the loader to facilitate loading and unloading so as to provide more efficient processing.
Core Innovation
The present invention provides a handling system for high throughput processing of a plurality of biological samples, each sample being within a respective cartridge of a plurality of diagnostic assay cartridges. The system can include an array support assembly adapted to support a plurality of diagnostic assay modules in an array having at least two dimensions, and a loader adapted to load each of the plurality of diagnostic assay cartridges within a diagnostic assay module within the array, wherein the array support assembly is movable relative the loader such that the cartridge is loadable in any of the modules within the array by moving the loader relative the array.
The invention addresses the need for high-throughput assay systems to process large volumes of biological samples more efficiently and expediently, as conventional methods that process samples one at a time or by batch lead to delays, increased turn-around-time and higher costs. The background describes that conventional large-scale systems are exceedingly large, often requiring oversized rooms and high capital costs, and that there is a need for high throughput handling systems amenable to incorporation into existing testing facilities where access, space and costs are of particular concern.
Embodiments include an array that can be cylindrical or other geometrical configurations, diagnostic assay modules that are independently operable and adapted for receiving diagnostic assay cartridges and performing diagnostic assays, and coordinated control by a controller and an automation computer to move the array support relative the loader for loading and unloading. The system further contemplates integrated features for managing thermal conditions of the array microenvironment and methods of handling samples that include receiving diagnostic assay cartridges and loading each cartridge into a respective diagnostic assay module by moving the array support relative the loader [procedural detail omitted for safety].
Claims Coverage
One independent claim is identified. The following inventive features are extracted from the independent claim.
Movable array support assembly
An array support adapted to support a plurality of diagnostic assay modules in an array having at least two dimensions, wherein the array support assembly is movable relative the loader such that the diagnostic assay cartridge is loadable in any of the diagnostic assay modules within the array by the moving of the array support structure relative the loader in combination with the loader.
Loader releasably coupling with diagnostic assay cartridges
A loader that receives each of the plurality of diagnostic assay cartridges in the high throughput processing system with a loader by releasably coupling with each of the plurality of diagnostic assay cartridges and loads each cartridge into a receiving bay of a respective diagnostic assay module.
Diagnostic assay modules adapted for receiving cartridges and performing assays
Each diagnostic assay module comprising a diagnostic assay system adapted for receiving a diagnostic assay cartridge of the plurality and performing a diagnostic assay on a biological sample within the respective cartridge.
Controller coordinated movement of array and loader
Loading comprises moving the array support relative the loader by a controller of the system coupled with an automation computer such that the diagnostic assay cartridge is loadable in any of the diagnostic assay modules within the array by the moving of the array support structure relative the loader in combination with the loader.
The independent claim centers on a high-throughput handling method combining (1) an array support assembly that supports multiple diagnostic assay modules, (2) a loader that releasably couples with diagnostic assay cartridges to load them into module receiving bays, (3) diagnostic assay modules adapted to receive cartridges and perform assays, and (4) controller/automation-computer coordinated movement of the array support relative to the loader to enable loading into any module.
Stated Advantages
High throughput processing of a large volume of biological samples.
More efficient and expedient processing with improved throughput and reduced turn-around-time compared to conventional systems.
Movable array relative to the loader to facilitate faster loading and unloading and provide more efficient processing.
Compact footprint and transportability, including array dimensions suitable for transport through a standard sized doorway, enabling installation in existing testing facilities with access and space constraints.
Modular design wherein diagnostic assay modules can be independently operable and removed or replaced without dismantling other modules.
Integrated thermal management to maintain suitable ambient conditions in the array microenvironment for hardware functionality and assay integrity.
Documented Applications
Performing diagnostic assays and high throughput processing of large volumes of biological samples for purposes including disease diagnosis, pathogen detection, gene discovery, drug development, and genetic-related technologies and research.
Processing diagnostic assay cartridges configured for nucleic acid amplification tests (NAAT), including Polymerase Chain Reaction (PCR) and related nucleic acid amplification methods.
Use in laboratories, diagnostic testing centers, and hospital or clinical settings where high-volume sample processing and reduced turn-around-time are desired.
Integration with automated sample preparation workflows and cartridge preparers that perform pre-analytic steps and position prepared diagnostic assay cartridges into the system's loading track.
Ultra-high throughput configurations combining multiple array assemblies into a single system to process extremely high-volume streams of diagnostic assay cartridges.
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