Devices and methods for the detection of molecules using a flow cell
Inventors
Andreyev, Boris • Bhatia, Rajinder K. • Briones, Victor • CAO, Phoebe • Ching, Jesus • Ciopyk, Brian • De La Zerda, Adam • HONG, Jonathan H. • Huang, Helen • Kelly, Colin • LAM, Adrienne C. • Loney, Gregory • MCSHEERY, Danielle • Moravick, Keith E. • REVILLA, Valeria • Roy, Shaunak • Swenson, David D.
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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-10675623-B2
Publication Date
2020-06-09
Expiration Date
Abstract
A method includes conveying a detection solution containing a target amplicon into a detection module of a molecular diagnostic test device. The detection module includes a detection surface including a series of capture probes to which a first portion of the target amplicon is bound when the detection solution is conveyed. A first reagent formulated to produce a visible signal indicating a presence of the target amplicon is then conveyed into the detection module. The first reagent is bound to a second portion of the target amplicon when the first reagent is conveyed. A second reagent is conveyed into the detection module. The second reagent includes a precipitating substrate formulated to catalyze the production of the visible signal by producing an insoluble colored product when the second reagent is in contact with the first reagent. The method includes viewing the visible signal via a transparent portion of the detection module.
Core Innovation
The document describes a self-contained disposable molecular diagnostic test device in which nucleic-acid amplification produces a detection solution containing a target amplicon that is conveyed through a detection channel of a detection module. The detection channel is defined at least in part by a detection surface bearing a plurality of capture probes to which a first portion of the target amplicon is bound.
The device further conveys through the detection channel a first reagent formulated to cause production of a signal indicating a presence of the target amplicon, where the first reagent is bound to a second portion of the target amplicon when conveyed through the detection channel. A second reagent is conveyed through the detection channel and is formulated to catalyze production of the signal when the second reagent is in contact with the first reagent.
In related implementations, the second reagent is formulated to produce the signal by producing an insoluble colored product when contacted with the first reagent. The visible color is read through a transparent portion of the detection module, and in other implementations a result associated with the signal is read via a status window of the housing.
The device includes modules for a sample input volume, amplification, and detection, with lysis and amplification producing an input sample and a detection solution containing the target amplicon. Mechanical lock-out concepts are included through lid and actuator interactions to retain a positioned actuator, including a lock protrusion engaged with a lock surface to retain the actuator in a first position when the lid is opened and disengaged when the lid is in a closed position, and an irreversibly engaging lock protrusion that maintains a reagent actuator in a second position.
Claims Coverage
The partial content includes two independent method claims. The independent claims each include sample loading and device actuation, amplification to produce a detection solution with a target amplicon, capture on a detection surface with capture probes, and signal generation in the detection channel by reacting first and second reagents to indicate the presence of the target amplicon; Claim 15 additionally specifies precipitating substrate-driven insoluble colored product signaling and reading via a housing status window.
Self-contained actuatable sample-to-amplification-to-detection workflow with lid-actuator lock
Loading a biological sample via an opening defined by an actuator, moving a lid to a closed position so a lock protrusion engages a lock surface to retain the actuator in a first position when the lid is opened and disengages when the lid is closed, and actuating the device to convey the biological sample to an amplification module, heat an amplification portion to amplify nucleic acid to produce a detection solution containing the target amplicon, convey the detection solution through a detection channel defined at least in part by a detection surface including a plurality of capture probes, convey through the detection channel a first reagent bound to a second portion of the target amplicon, convey through the detection channel a second reagent formulated to catalyze production of the signal, and reading a result associated with the signal.
Reagent containers with irreversibly locked reagent actuation producing insoluble colored product signal and status-window reading
Including a first container containing a first reagent and a second container containing a second reagent within a housing, actuating a reagent actuator coupled to the housing to release the first and second reagents while a lock protrusion irreversibly engages a shoulder to maintain the reagent actuator in a second position, heating the biological sample within a lysis module to lyse a portion to produce an input sample, heating the input sample within an amplification module to amplify nucleic acid to produce a detection solution containing a target amplicon, conveying the detection solution through a detection channel defined at least in part by a detection surface including a plurality of capture probes, reacting within the detection channel the captured target amplicon with the first reagent and the second reagent to produce a signal indicating presence of the target amplicon where the first reagent is formulated to cause production of the signal and the second reagent includes a precipitating substrate formulated to produce the signal by producing an insoluble colored product when contacted with the first reagent, and reading via a status window of the housing a result associated with the signal.
Across the independent claims, the inventive coverage is directed to a self-contained molecular diagnostic test device method in which a target amplicon is amplified and then captured on a detection surface with capture probes, followed by signal generation in the detection channel by reaction of a first reagent and a second reagent, with mechanical lock concepts for actuator positioning and result reading via a transparent detection portion or a housing status window.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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