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
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.
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
A thermocycling apparatus is provided with a first chamber, a second chamber, and a channel, formed by a top laminate and a bottom laminate. The first chamber and the second chamber are separated by the channel, and the top laminate and the bottom laminate include membrane materials and thickness as specified. The apparatus includes a heater configured to contact at least one of the top laminate or the bottom laminate.
The apparatus includes a first plunger configured to press the first chamber and a second plunger configured to press the second chamber. The laminate-defined chamber structure, together with the plungers and the heater, enables thermal cycling using sample fluid located in the first chamber and the second chamber. The heater contacts the laminate to provide thermal control of the chamber regions.
A channel pathway is formed to move a sample between the first chamber and the second chamber so that the sample temperature transitions between a first average temperature and a second average temperature at a transition rate. The apparatus further includes configurations that define quantitative transition-rate thresholds for the temperature transition during movement between chambers. Additional heater architectures and temperature sensing are included as refinements tied to the disposable portion.
Claims Coverage
The independent claim provides the laminate thermocycling architecture with a first chamber, a second chamber, and a channel formed by top and bottom laminates, pressed by separate plungers, and heated by a heater contacting the laminate. The dependent claims refine the same apparatus by adding a channel pathway for moving a sample between chambers, setting different average temperatures for thermal cycling between the two chambers, adding quantitative transition-rate thresholds, specifying an air-gap-separated heater configuration, and coupling a temperature sensor to a disposable portion.
Laminate-formed first and second chambers with a channel
A thermocycling apparatus comprising a first chamber, a second chamber and a channel, where the first chamber, the second chamber and the channel are formed by a top laminate and a bottom laminate, with the first chamber and the second chamber separated by the channel.
Plungers press respective chambers
A thermocycling apparatus including a first plunger configured to press the first chamber and a second plunger configured to press the second chamber.
Heater contacts at least one laminate
A thermocycling apparatus including a heater configured to contact at least one of the top laminate or the bottom laminate.
Channel pathway moves a sample between chambers
A thermocycling apparatus that includes a channel pathway allowing a sample to move between the first chamber and the second chamber.
Different average temperatures in the two chambers
A thermocycling apparatus that heats the first chamber and the second chamber to different average temperatures so a sample can be thermally cycled when moved between them.
Quantitative temperature transition rate threshold
A thermocycling apparatus where moving the sample between the first chamber and the second chamber causes the sample temperature transition between a first average temperature and a second average temperature at a transition rate of 10 μL °C/second or more.
Air-gap-separated heater architecture
A thermocycling apparatus that includes first and second heaters separated by an air gap.
Temperature sensing coupled to a disposable portion
A thermocycling apparatus including a temperature sensor coupled to a disposable portion of the apparatus.
Across the independent claim and its refinements, the claims focus on a laminate-based thermocycling cartridge architecture with two chambers separated by a channel, pressed by respective plungers, and heated by a heater contacting the laminate. Refinements add sample transfer between chambers via a channel pathway, thermal cycling using different average chamber temperatures, quantitative temperature-transition rate thresholds during transfer, an air-gap-separated heater configuration, and temperature sensing coupled to a disposable portion.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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