Cartridge-based thermocycler
Inventors
TANG, Hamilton R. • De La Zerda, Adam • Li, Kenneth I. • LIMTAO, Kevin M. • Baldwin, Alan D. • Loney, Gregory C.
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Assignees
Member
Visby MedicalVisby Medical develops rapid at-home molecular diagnostic tests powered by polymerase chain reaction (PCR) technology, focusing on accessible, private, and accurate screening for sexually transmitted infections (STIs). The company offers the first FDA-authorized over-the-counter at-home PCR test for women’s sexual health and is expanding its diagnostics platform to address other infectious diseases for point-of-care and home use. Its technology enables results in approximately 30 minutes via a secure mobile app, with integrated telehealth services for positive results. Visby Medical emphasizes user privacy, scalable manufacturing, and partnerships to broaden access to high-quality diagnostics.
Visby Medical develops rapid at-home molecular diagnostic tests powered by polymerase chain reaction (PCR) technology, focusing on accessible, private, and accurate screening for sexually transmitted infections (STIs). The company offers the first FDA-authorized over-the-counter at-home PCR test for women’s sexual health and is expanding its diagnostics platform to address other infectious diseases for point-of-care and home use. Its technology enables results in approximately 30 minutes via a secure mobile app, with integrated telehealth services for positive results. Visby Medical emphasizes user privacy, scalable manufacturing, and partnerships to broaden access to high-quality diagnostics.
Publication Number
US-10195610-B2
Publication Date
2019-02-05
Expiration Date
Abstract
Cartridge-based thermocyclers can include cartridges that are configured to move a fluid between distinct chambers. In some cases, the cartridge-based thermocyclers can be used for thermocycling a sample fluid comprising a deoxyribonucleic acid (DNA) target to perform polymerase chain reaction (PCR). Individual chambers can be heated, cooled, and/or compressed to mix fluid within the chamber or to propel fluid in the chamber into another chamber. The cartridges can have a laminate construction. The cartridges can be configured to enable multiplexed thermocycling and/or detection.
Core Innovation
The invention provides a cartridge-based amplification module constructed from a plurality of layers, where a sample is thermally cycled by repeatedly flowing between a first chamber portion and a second chamber portion maintained at different average temperatures. A sample having a starting volume of at least 50 μL is conveyed into the first chamber portion, and a flow is produced to move the sample into the second chamber portion so that thermal cycling occurs when moved between the portions.
The amplification module uses layered construction including a top layer, a bottom layer, a first adhesive layer coupled to the top layer, and a second adhesive layer coupled to the bottom layer, with at least one of the top layer or bottom layer comprising poly (4,4′-oxydiphenylene-pyromellitimide. PCR is completed by repeatedly flowing the sample between the first chamber portion and the second chamber portion, with the invention emphasizing substantially shorter PCR cycle times enabled by rapid thermal transitions between the different average temperatures.
The invention further includes heating the first portion to a first average temperature and heating the second portion to a second average temperature different than the first average temperature, while producing a flow of the sample such that the sample transitions from the first average temperature to substantially the second average temperature at a rate of 10 μL·°C/second or more. The sample is thermally cycled during transfer from the first portion to the second portion, and PCR is completed by repeatedly flowing the sample between the first and second portions at least 20 times.
Claims Coverage
Independent claims are directed to a PCR method using an amplification module with layered chamber portions, where thermally cycling is achieved by repeatedly flowing the sample between first and second portions at different average temperatures, including constraints on layered construction and rapid transition/flow repetition.
Thermally cycled PCR by repeatedly flowing between layered chamber portions at different average temperatures
A method for performing PCR that conveys a sample having a starting volume of at least 50 μL into a first chamber portion of an amplification module having a first average temperature; produces a flow of the sample from the first chamber portion to a second chamber portion having a second average temperature different than the first average temperature such that the sample is thermally cycled when moved from the first chamber portion to the second chamber portion; the amplification module is constructed from a plurality of layers to define the first and second chamber portions; and completes the PCR by repeatedly flowing the sample between the first chamber portion and the second chamber portion.
Rapid thermally cycled PCR with transition rate and repeated flows using layered amplification module
A method for performing PCR that conveys a sample having a starting volume of at least 50 μL into an amplification module with a first portion and a second portion constructed from a plurality of layers including a top layer, a bottom layer, a first adhesive layer coupled to the top layer, and a second adhesive layer coupled to the bottom layer, with at least one of the top layer and bottom layer comprising poly (4,4′-oxydiphenylene-pyromellitimide; heats the first portion to a first average temperature and heats the second portion to a second average temperature different than the first; produces a flow from the first portion to the second portion such that the sample is thermally cycled when moved and such that the sample transitions from the first average temperature to substantially the second average temperature at a rate of 10 μL° C./second or more; and completes PCR by repeatedly flowing the sample between the first and second portions at least 20 times.
Across the independent claims, the core claim coverage is the combination of a layered amplification module with adhesive layers and at least one poly (4,4′-oxydiphenylene-pyromellitimide) layer, and thermally cycling PCR achieved by producing a flow of the sample between first and second portions at different average temperatures, with a transition rate of 10 μL·°C/second or more and completion after at least 20 repeated flows.
Stated Advantages
Substantially shorter PCR times enabled by rapid thermal transitions between chamber portions.
PCR efficiency is maintained at at least about 92%.
Documented Applications
Real-time fluorescence monitoring and qRT-PCR diagnostic example using optical interrogation/multiplexable assay concepts.
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