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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-12061138-B2
Publication Date
2024-08-13
Expiration Date
Abstract
A biological sample processing apparatus having an enclosure. A plurality of sample processing modules are held by the enclosure. Each sample processing module is configured to hold a removable sample cartridge and to only perform sample processing on a sample within the corresponding removable sample cartridge. Each sample processing module is configured to perform at least one of a plurality of testing processes on the sample within the removable sample cartridge. At least one module in the apparatus is configured to perform nucleic acid amplification and detection.
Core Innovation
A biological sample processing apparatus having an enclosure that holds a plurality of sample processing modules, wherein each sample processing module is configured to hold a removable sample cartridge and to only perform sample processing on a sample within the corresponding removable sample cartridge. Each sample processing module is configured to perform at least one of a plurality of testing processes on the sample within the removable sample cartridge, and at least one module in the apparatus is configured to perform nucleic acid amplification and detection.
The analysis of samples such as clinical or environmental samples generally involves a series of processing steps, which may include separate chemical, optical, electrical, mechanical, thermal, or acoustical processing of the samples. Conventional systems for processing samples are each typically dedicated to one type of assay and because different assays require different configurations, conventional systems are not versatile nor easily adaptable to different protocols; there is an unanswered need to condense these systems in a manner that remains flexible for the present and future needs of a user.
At least one module in the apparatus can be a sample preparation module configured to only perform sample preparation, and the plurality of sample processing modules can include different modules configured for different types of sample processing. The plurality of sample processing modules can include modules configured for immunoassays for protein detection, hybridizing a nucleic acid to an array on a solid support, nucleic acid amplification and detection in a multiplex array of wells, assessing a chromosomal copy number, multiplex detection of nucleic acid or protein analytes, and sequencing and detecting a nucleic acid molecule.
Claims Coverage
Overview: One independent claim (claim 1) recites a method with multiple inventive features concerning an apparatus having removable, independently operable modules and steps for preparing and testing a sample using removable sample cartridges.
Enclosure holding a plurality of removable, independently operable modules
An enclosure holding a plurality of sample processing modules and a sample preparation module, wherein each of the plurality of modules are removable and independently operable from each other module of the plurality.
Sample preparation module configured to only perform sample preparation on a single sample at a time
Receiving a sample cartridge holding an unprepared sample in the sample preparation module, the sample preparation module being configured to only perform sample preparation on a single sample at a time within a corresponding removable sample cartridge when accommodated therein; the sample cartridge containing one or more reagents required for sample preparation; preparing the sample for a corresponding biological testing process within the sample cartridge using the sample preparation module in which the sample cartridge was received.
Sample processing modules configured to perform biological testing processes on a prepared sample
Receiving the sample cartridge holding the prepared sample in one of the plurality of sample processing modules of the apparatus, each sample processing module being configured to perform at least one of a plurality of biological testing processes on a single prepared sample in a given removable sample cartridge when accommodated therein.
Performing the biological testing process within the corresponding sample processing module
Performing the at least one biological testing process on the prepared sample within the sample cartridge using the corresponding sample processing module in which the sample cartridge was received.
The independent claim recites a method that combines an enclosure with removable, independently operable sample processing and sample preparation modules, use of removable sample cartridges containing required reagents, a defined sequence of preparing a sample in a sample preparation module and then receiving the prepared sample in a sample processing module, and performing at least one biological testing process within the corresponding sample processing module.
Stated Advantages
Modularity enabling different chemical reactions and sample preparations to be run simultaneously by independently controllable processing modules.
Standardized cartridge interface so the same removable sample cartridge can be used within multiple types of sample processing modules.
Modularity that permits individual modules to be removed for servicing, repair, or replacement, reducing downtime and enabling upgrades or enlargement of the instrument.
Shared chassis footprint and electronic interface so types of modules can be changed with little difficulty.
Semi-portable housing configured to be used within a laboratory environment akin to a desktop computer.
Documented Applications
Performing multiple types of assays and related sample preparation including immunoassay, PCR, rapid PCR, sequencing, chromosomal analysis, and flow cytometry.
Detection of different target analytes including nucleic acid, whole cell, DNA, RNA, protein, virus, drugs, and biothreat analytes such as anthrax or ricin.
Sample preparation processes such as lysis, chemical treatment, filtration, isolation or purification of at least one nucleic acid, and isolation or purification of a particular cell type.
Multiplex assays, including nucleic acid amplification and detection in a multiplex array of wells, multiplex detection by hybridization to a detection array of at least two nucleic acid analytes, and multiplex detection of at least two protein analytes.
Assessing a chromosomal copy number of at least one gene of interest and sequencing and detecting a nucleic acid molecule.
Performing flow cytometry on a mixed population of cells and isolating/purifying a particular cell type such as a circulating tumor cell expressing a particular cell surface marker.
Use within a laboratory environment as a semi-portable, desktop-like instrument with a housing/enclosure and front-facing interface panel providing user access to plurality of processing modules.
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