Devices and methods for molecular diagnostic testing
Inventors
Andreyev, Boris • Moravick, Keith E. • Ciopyk, Brian • Briones, Victor • Loney, Gregory • De La Zerda, Adam • Ching, Jesus • Chu, Steven • Swenson, David • Huang, Helen • Kelly, Colin
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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-11167285-B2
Publication Date
2021-11-09
Expiration Date
Abstract
A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.
Core Innovation
The invention relates to a disposable molecular diagnostic test device for point-of-care use and a stand-alone molecular diagnostic test device. A detachable sample input device or sample transfer device is matingly received within an input portion, and moving the proximal end portion relative to the test device actuates a switch of a control module.
In response to actuation, the control module provides power from a power source to a heater of an amplification module within the housing. The heater transfers heat into a reaction volume defined by the amplification module or within a flow path to amplify the sample or target nucleic acid and produce a target amplicon.
Within the disposable molecular diagnostic test device or flow path, the target amplicon reacts with a reagent formulated to produce a signal indicating a presence of the target amplicon within the sample or biological sample. A result associated with the signal is read, and the disposable molecular diagnostic test device is discarded after the reading.
Claims Coverage
Independent claim coverage is provided by two independent claims. Both claims center on movement of a detachable sample input or transfer device to actuate a control module switch, followed by heater-powered amplification in a defined reaction volume, reagent-based signal generation, and result reading.
Disposable sample input actuation with heater-controlled amplification
Loading a sample into a sample input device with a proximal end portion and a distal end portion that matingly receives the distal end portion within an input portion of a disposable molecular diagnostic test device; moving the proximal end portion from a first position to a second position to actuate a switch of a control module; causing the control module to provide power from a power source to a heater of an amplification module.
Reagent reaction and signal-based result reading followed by discarding
Amplifying the sample conveyed from the sample input device by transferring heat from the heater into a reaction volume defined by the amplification module to produce the target amplicon; reacting, within the disposable molecular diagnostic test device, the target amplicon with a reagent formulated to produce a signal indicating a presence of the target amplicon within the sample; reading a result associated with the signal; discarding, after the reading, the disposable molecular diagnostic test device.
Stand-alone test device flow-path delivery with switch actuation
Providing a stand-alone molecular diagnostic test device comprising an input portion, a flow path adapted to receive a biological sample, a reaction volume within the flow path, a control module, a power source, and a heater; loading the biological sample into a sample reservoir defined within a sample transfer device; moving, after the distal end portion of the sample transfer device is received within the input portion, the proximal end portion relative to the molecular diagnostic test device to cause the biological sample to flow from the sample reservoir into the flow path and to cause actuation of a switch of the control module.
Amplify, react to produce a signal in the flow path, and read the result
After the switch is actuated, providing power from the power source to the heater to amplify, within the reaction volume, the target nucleic acid within the biological sample to produce a target amplicon; reacting, within the flow path, the target amplicon with a reagent formulated to produce a signal indicating a presence of the target amplicon within the biological sample; reading a result associated with the signal.
The independent claims combine movement-driven switch actuation of a control module, heater-powered amplification within a defined reaction volume, reagent-driven generation of a signal indicating presence of a target amplicon, and reading of a result; the disposable claim further includes discarding the device after reading.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Point-of-care use.
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