Portable molecular diagnostic device and methods for the detection of target viruses
Inventors
Andreyev, Boris • Briones, Victor • CENA, Ryan T. • De La Zerda, Adam • Kelly, Colin • Loney, Gregory • Schoolnik, Gary • Swenson, David
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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-11162130-B2
Publication Date
2021-11-02
Expiration Date
Abstract
A method includes coupling a molecular diagnostic test device to a power source. A biological sample is conveyed into a sample preparation module. The device is then actuated by only a single action to cause the device to perform the following functions without further user action. First, the device heats the sample via a heater of the sample preparation module to lyse a portion of the sample. Second, the device conveys the lysed sample to an amplification module and heats the sample within a reaction volume of the amplification module to amplify a nucleic acid thereby producing an output solution containing a target amplicon. The device then reacts, within a detection module, each of (i) the output solution and (ii) a reagent formulated to produce a signal that indicates a presence of the target amplicon within the output solution. A result associated with the signal is then read.
Core Innovation
The invention is a disposable, stand-alone portable molecular diagnostic test device for viral nucleic-acid detection. The device performs end-to-end processing including sample input, lysis and/or reverse transcription and amplification, and detection within the device, and the operation is initiated by a single action using an internal heater architecture and an electronic control module.
A biological sample is conveyed into a sample preparation module via a sample input opening and the sample input opening is covered with a lid coupled to the device. The lid includes a switch portion, and covering the opening causes actuation of a switch of the electronic control module; in related aspects, the lid can also include a reagent actuator that releases a detection reagent from a reagent container, and the lid can include an irreversible lock to prevent uncovering or re-opening after actuation and use.
In response to the actuation, the device produces an input sample and conveys the input sample to an amplification module within the molecular diagnostic test device. The amplification module includes a heater and defines a reaction volume, and power is provided to the heater to heat the input sample within the reaction volume to amplify the nucleic acid, thereby producing an output solution or detection solution containing a target amplicon, which is then reacted in a detection module with a reagent formulated to produce a signal indicating presence of the target amplicon and a result is read.
Related aspects describe reverse transcription heating to produce complementary deoxyribonucleic acid (cDNA) before amplification. The document further describes multi-purpose reagent concepts, including a blocking agent and a wash agent, optional reagent reuse/recycling, and an integrated lysing and RT-PCR approach in one environment to limit RNA degradation.
Claims Coverage
Three independent claims cover automated nucleic-acid detection using lid-based single-action actuation, heater-based amplification in a reaction volume, reagent-based signal generation in a detection module, and reading a result. The independent claims further include lid actuator-driven detection reagent release and reverse transcription temperature range heating to produce cDNA, followed by reading and, in one claim, discarding the device after use.
Single-action lid actuation for end-to-end nucleic-acid detection
Covering the sample input opening with a lid coupled to the device, where the lid includes a switch portion and moving the switch portion actuates a switch to cause the device to produce an input sample, convey the input sample to an amplification module with a heater defining a reaction volume, provide power to the heater to heat the input sample to amplify nucleic acid producing an output solution containing a target amplicon, react within a detection module each of the output solution and a reagent formulated to produce a signal indicating presence of the target amplicon, and reading a result associated with the signal.
Lid actuator-released detection reagent with heated amplification and signal reading
Covering the sample input opening with a lid coupled to the device, where the lid includes a reagent actuator and moving the reagent actuator causes a detection reagent to be released from a reagent container of the device; in response to only the covering the sample input opening, causing the device to heat the biological sample via a heater of the sample preparation module to produce an input sample, convey the input sample to an amplification module defining a reaction volume, heat the input sample within the reaction volume to amplify nucleic acid to produce an output solution containing a target amplicon, react within a detection module each of the output solution and the detection reagent formulated to produce a signal indicating presence of the target amplicon, and reading a result associated with the signal.
Reverse transcription temperature range cDNA production and discarding after reading
Manipulating a lid to place the lid in a closed position about the sample input opening so that a switch portion causes actuation of a switch in response to the lid being moved to the closed position; in response to only the manipulating the lid, causing the device to provide power to a heater after the switch is actuated to heat the biological sample to a first temperature within a reverse transcription temperature range to produce complementary deoxyribonucleic acid (cDNA), heat the biological sample within a reaction volume to amplify the cDNA thereby producing a detection solution containing a target amplicon, react each of the detection solution and a reagent formulated to produce a signal indicating presence of the target amplicon, reading a result associated with the signal, and discarding the molecular diagnostic test device after the reading.
The independent claims collectively require an automated nucleic-acid detection workflow triggered by lid-based actuation, including switch portion actuation and, in one claim, reagent actuator-driven detection reagent release. The workflow includes heating via an internal heater to amplify nucleic acid in a reaction volume to generate an output or detection solution containing a target amplicon, reacting with a formulated reagent in a detection module to produce a signal indicative of target amplicon presence, and reading a result; one independent claim additionally requires reverse transcription temperature range heating to produce cDNA and discarding the device after reading.
Stated Advantages
Provides actuation of the molecular diagnostic test device by only a single action of covering the sample input opening with the lid.
Enables detection of a target amplicon via a signal produced by reacting an output or detection solution with a formulated reagent.
Allows reverse transcription by heating the biological sample within a reverse transcription temperature range to produce cDNA.
Includes discarding the molecular diagnostic test device after reading.
Limits RNA degradation through an integrated lysing and RT-PCR approach in one environment.
Documented Applications
Point-of-use workflow for a molecular diagnostic device where a biological sample is loaded via a sample input opening, the lid is closed to actuate electronic control and reagent modules, and then the device is powered via a power cord by single-action lid closing.
Detecting HIV-1 RNA using an RT-PCR device with in-line reverse transcription and a serpentine PCR module, including multiplex primer sets with MS2 control.
Respiratory infection detection for Influenza A/B and RSV, including cross-reactivity pathogen panels and positive controls.
Isothermal amplification is broadly mentioned as an option, including LAMP, NASBA, SDA, MDA, and RAM, for amplification on the platform.
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