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-10456783-B2
Publication Date
2019-10-29
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 describes an apparatus with a housing that includes a sample input module defining a sample input volume to receive an input sample. Within the sample input volume, the apparatus includes a solid control organism that is nonpathogenic to humans and is rehydrated and mixed with the input sample when the input sample is conveyed from the sample input volume. An amplification module coupled within the housing defines a reaction volume and includes a heater for amplifying a control nucleic acid in the control organism to produce a control amplicon while amplifying a target nucleic acid in the input sample to produce a target amplicon.
A reagent is formulated to produce a first signal indicating a presence of the target amplicon and a second signal indicating a presence of the control amplicon. The detection module receives an output produced by the amplification module that includes both the target amplicon and the control amplicon, and the detection module includes a first detection surface and a second detection surface configured to interact respectively with the target amplicon and the control amplicon to produce the corresponding signals when the reagent is present.
The invention further describes a flow-through serpentine PCR chip having heater-defined temperature zones, configured to perform PCR amplification cycles while the sample flows through the reaction volume. The detection module is implemented as a non-fluorescent, enzyme-linked colorimetric assay that uses a detection flow cell with multiple probe spots for target organism probes and positive and negative control spots. The apparatus is powered and controlled for heater and motor operation in a battery-powered implementation, supporting regulated operation of the amplification and detection modules.
Claims Coverage
The provided independent claims cover two apparatus embodiments. Each independent claim includes four inventive features: a housing with sample input and a nonpathogenic solid control organism, an amplification module with a heater that produces both target and control amplicons, a reagent that indicates presence of the target and control amplicons via distinct signals, and a detection module with separate detection surfaces that generate the respective signals.
Nonpathogenic solid control organism rehydrated and mixed
a solid control organism within the sample input volume, the solid control organism being nonpathogenic to humans and being rehydrated and mixed with the input sample when the input sample is conveyed from the sample input volume
Heater-based amplification producing target and control amplicons
an amplification module coupled within the housing and configured to receive the input sample, the amplification module defining a reaction volume and including a heater, the amplification module configured to amplify a control nucleic acid within the control organism to produce a control amplicon along with amplification of a target nucleic acid within the input sample to produce a target amplicon
Reagent producing target and control signals
a reagent formulated to produce a first signal indicating a presence of the target amplicon and a second signal indicating a presence of the control amplicon
Detection surfaces producing first and second signals for target and control
a detection module that receives an output produced by the amplification module including the target amplicon and the control amplicon, the detection module including a first detection surface and a second detection surface, the first detection surface configured to interact with the target amplicon such that when the detection module contains the reagent the first signal is produced from the first detection surface, the second detection surface configured to interact with the control amplicon such that when the detection module contains the reagent the second signal is produced from the second detection surface
Across the independent claims, the inventive coverage centers on pairing a nonpathogenic solid control organism with amplification that generates both a target amplicon and a control amplicon, and using a reagent and detection module with separate detection surfaces to generate corresponding first and second signals for target and control presence.
Stated Advantages
Rapid time-to-result for point-of-care operation.
Battery power operation for a handheld, disposable molecular diagnostic test device.
CLIA-waivable operation.
Lock-out mechanisms to prevent reuse or misuse.
Non-fluorescent visible detection using first and second detection surfaces without relying on an excitation light source inside the housing.
Produces a first signal indicating presence of the target amplicon and a second signal indicating presence of the control amplicon.
Provides separate first and second signals from first and second detection surfaces corresponding to target and control amplicons.
Documented Applications
Point-of-care molecular diagnostic testing using a handheld integrated molecular diagnostic test device.
Infectious disease detection, including an STI panel.
UTI panel.
Universal reagents.
URI/HAI.
Viral sample handling.
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