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 • Kelly, Colin • Chu, Steven • Swenson, David • Huang, Helen
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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-9623415-B2
Publication Date
2017-04-18
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 provides a molecular diagnostic test device in which the amplification module and the detection module are integrated within a housing together with a sample preparation module. The sample preparation module includes a sample input module and a filter assembly disposed within the housing, with an inlet port configured to receive an input sample and an outlet port for conveying the sample. A sample actuator applies force to convey the input sample through the filter assembly when moved from a first position to a second position, and a tab irreversibly engages a portion of the housing to maintain the sample actuator in the second position.
The amplification module is configured to receive the input sample from the sample preparation module and defines a reaction volume including a heater such that the amplification module can perform polymerase chain reaction (PCR). The detection module defines a detection channel configured to receive an output from the amplification module and a reagent formulated to produce a signal indicating a presence of a target amplicon within the input sample. The integrated device architecture combines sample preparation, PCR amplification, and detection within a single housing.
Claims Coverage
The document includes two independent claims. The inventive features concentrate on integrating sample preparation, PCR amplification, and detection within a single disposable housing, and on actuator-based sample conveyance with irreversible locking, followed by viewing of a visible colored signal indicating a target amplicon.
Integrated molecular diagnostic device within a single housing
The amplification module, the sample preparation module, and the detection module are integrated within the housing.
Sample preparation module with filter and actuator-driven conveyance
A sample preparation module including a sample input module and a filter assembly disposed within the housing, the sample input module including an inlet port configured to receive an input sample and an outlet port; a sample actuator operatively coupled to the sample input module and configured to apply a force to convey the input sample from the outlet port through the filter assembly when the sample actuator is moved from a first position to a second position, with a tab configured to irreversibly engage a portion of the housing to maintain the sample actuator in the second position.
PCR amplification module with defined reaction volume and heater
An amplification module configured to receive the input sample from the sample preparation module, the amplification module defining a reaction volume and including a heater such that the amplification module can perform polymerase chain reaction (PCR) on the input sample.
Detection module producing a signal indicating presence of a target amplicon
A detection module defining a detection channel 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 main inventive features are the integrated within-housing combination of sample preparation, heater-based PCR amplification in a defined reaction volume, and detection using a reagent that produces a signal indicating a target amplicon, with actuator-driven sample conveyance through a filter assembly and irreversible locking in the second actuator position.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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