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-10279346-B2
Publication Date
2019-05-07
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 molecular diagnostic test device and methods of detecting a target nucleic acid molecule. A biological sample is conveyed from a sample input volume within the device toward an amplification module so that a solid control organism, nonpathogenic to humans, is rehydrated and mixed with the biological sample to form an input solution. The amplification module defines a reaction volume and includes a heater.
Heating amplifies a control nucleic acid within the control organism and a target nucleic acid molecule within the biological sample, thereby producing an output solution containing a target amplicon and a control amplicon. The output solution is reacted within a detection module in the housing with a reagent to produce a first signal indicating a presence of the target amplicon and a second signal indicating a presence of the control amplicon.
In some implementations, the signals are produced as non-fluorescent visible signals without an excitation light source inside the device housing. The amplification module includes a serpentine flow channel reaction volume and heater segments configured to create first and second temperature zones, and the input solution is flowed through portions of the serpentine flow channel to thermally cycle between the temperature zones.
Claims Coverage
The document provides two independent method claims. Across these independent claims, the core inventive coverage centers on mixing a solid nonpathogenic control organism into a biological sample, heater-based amplification producing both target and control amplicons, and detection in a detection module that produces a first signal for the target amplicon and a second signal for the control amplicon.
Rehydrating and mixing a solid nonpathogenic control organism with the biological sample
Conveying a biological sample from a sample input volume defined by a sample input module towards an amplification module to rehydrate and mix a solid control organism within the sample input volume with the biological sample to form an input solution, the solid control organism being nonpathogenic to humans, the sample input module and the amplification module each coupled within a housing of the molecular diagnostic test device.
Heater amplification of both target and control nucleic acids
Heating the input solution within at least a portion of the reaction volume via the heater to amplify a control nucleic acid within the control organism and the target nucleic acid molecule within the biological sample thereby producing an output solution containing a target amplicon and a control amplicon.
Detection module producing separate target and control signals from reagent reaction
Reacting within a detection module within the housing each of the output solution and a reagent to produce a first signal indicating a presence of the target amplicon and a second signal indicating a presence of the control amplicon.
At least 30 thermal cycles amplification
Heating the input solution within the reaction volume via the heater through at least 30 thermal cycles to amplify a control nucleic acid within the control organism and the target nucleic acid molecule within the biological sample thereby producing an output solution containing a target amplicon and a control amplicon.
Both independent claims share the same core architecture: a nonpathogenic solid control organism is mixed with the sample, the heater amplifies both control and target nucleic acids to form target and control amplicons, and the detection module reacts the output solution with a reagent to generate a first signal for the target amplicon and a second signal for the control amplicon. The second independent claim further specifies amplification through at least 30 thermal cycles.
Stated Advantages
The signals are produced as non-fluorescent visible signals without an excitation light source inside the device housing.
Documented Applications
Infectious disease panels, including a STI 4-plex and a urinary tract infection panel.
STI panel with possibility of other panels and viral targets.
Universal reagent immunoabsorbent assay (URI).
Hemagglutination inhibition (HAI).
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