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-12037635-B2
Publication Date
2024-07-16
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 relates to portable disposable molecular diagnostic devices and a molecular diagnostic device that includes a reagent module disposed within a housing. The reagent module includes a reagent housing defining a reagent reservoir, and a reagent container containing a reagent sealed by a frangible seal, where a puncturer pierces the frangible seal so that the reagent is released into the reagent reservoir.
A deformable support member is included with the reagent module and includes a sealing portion and a coupling portion. The sealing portion is coupled to the reagent housing to fluidically isolate the reagent reservoir, and the coupling portion is coupled to at least one of the puncturer or the reagent container, while the deformable support member maintains the puncturer spaced apart from the frangible seal in a first configuration and allows the puncturer to pierce the frangible seal in a second configuration in response to an actuation force.
The disclosed device architectures further integrate a sample preparation module with a heater configured to heat a biological sample to produce an input solution, and a lid movably coupled to the housing between a first lid position exposing an input opening and a second lid position covering the input opening. The lid includes a reagent actuator configured to cause the deformable support member to deform when the lid is moved, supporting single-action sample-to-answer testing and controlled reagent release into the reagent reservoir.
Claims Coverage
The independent claims identified are clm-00001, clm-00011, and clm-00012. Across these three independent claims, the main inventive features center on configuration-dependent puncturing of a frangible-sealed reagent container by a deformable support member, fluidic isolation of a reagent reservoir, and, in one claim, integration with a sample preparation module and a lid-based actuator arrangement.
Configuration-dependent reagent release via deformable support puncturing
A housing of a molecular diagnostic device and a reagent module within the housing, where a reagent housing defines a reagent reservoir, a reagent container contains a reagent sealed by a frangible seal, and a puncturer pierces the frangible seal so that reagent is released into the reagent reservoir; a deformable support member deforms from a first configuration to a second configuration to maintain the puncturer spaced apart from the frangible seal in the first configuration and to permit piercing in the second configuration.
Lid-actuated sample preparation heater integrated with deformable reagent puncturing
A housing of a molecular diagnostic device with a reagent module having a reagent housing, a reagent container sealed therein, a puncturer, and a deformable support member that controls when the puncturer pierces a portion of the reagent container based on deformation from a first configuration to a second configuration; a sample preparation module defines a sample input volume, an input opening, and a heater configured to heat the biological sample to produce an input solution; and a lid movably coupled to the housing moves between a first lid position exposing the input opening and a second lid position covering the input opening, with a reagent actuator configured to cause the deformable support member to deform when the lid is moved.
Molecular diagnostic device configuration-dependent sealing and puncturing architecture
A molecular diagnostic device includes a reagent housing defining a reagent reservoir with a puncturer, a reagent container containing a reagent sealed by a frangible seal that is released into the reagent reservoir when the puncturer pierces the frangible seal, and a deformable support member with a sealing portion coupled to the reagent housing to fluidically isolate the reagent reservoir and a coupling portion coupled to the reagent container, where the deformable support member deforms from a first configuration to a second configuration in response to an actuation force to maintain the puncturer spaced apart from the frangible seal in the first configuration and to allow the puncturer to pierce the frangible seal in the second configuration.
The independent claims collectively define a configuration-dependent mechanical architecture that isolates a reagent reservoir and controls reagent release by deforming a deformable support member so a puncturer changes from being spaced apart from a frangible seal to piercing the frangible seal. One independent claim additionally requires integration of a sample preparation module with a heater and a lid with positions exposing or covering an input opening, where lid movement triggers deformation of the deformable support member via a reagent actuator.
Stated Advantages
Portable disposable molecular diagnostic operation using single-action sample-to-answer testing.
Reagent sealing and controlled release into a reagent reservoir enabled by configuration-dependent puncturing.
Fluidic isolation of the reagent reservoir in a first configuration.
Lockout to prevent reuse and long-term storage are discussed in the partial content summary of the document.
Documented Applications
Single-action sample-to-answer testing of target viruses using portable disposable molecular diagnostic devices.
An RT-PCR enhanced platform for HIV-1 RNA detection in finger-stick blood [procedural detail omitted for safety].
Multiplex detection using primer/capture approaches and detection configurations for multiple targets (CT/NG/TV) plus controls.
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