Devices and methods for molecular diagnostic testing
Inventors
Andreyev, Boris • Chu, Steven • Ciopyk, Brian • De La Zerda, Adam • Huang, Helen • Loney, Gregory • 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-10112196-B2
Publication Date
2018-10-30
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 stand-alone molecular diagnostic test device and method that detects a target nucleic acid without any external instrument. An input sample is conveyed from a sample preparation module to an amplification module fixedly coupled within a housing, and the housing has an overall size of less than about 260 cubic centimeters. The amplification module defines a reaction volume and includes a heater that heats the input sample to amplify the target nucleic acid molecule and produce an output solution containing a target amplicon.
The amplified output solution is reacted within a detection module within the housing with a reagent formulated to produce a signal indicating a presence of the target amplicon. The detection module includes a detection surface configured to capture the target amplicon to produce the signal. The device produces the signal in less than about 25 minutes after the input sample is conveyed from the sample preparation module.
A further aspect conveys a biological sample into a sample preparation module and actuates the device to heat the biological sample via a heater of a lysis module to lyse a portion of the biological sample and produce an input sample. The input sample is then conveyed to the amplification module to be heated through at least 30 thermal cycles to amplify nucleic acid and produce an output solution containing a target amplicon.
The detection module reacts the output solution with a reagent to produce a signal in less than about 25 minutes after actuating, and the method further includes reading a result associated with the signal and discarding, after the reading, the stand-alone molecular test device.
Claims Coverage
The document provides two independent claims covering a stand-alone, housing-based workflow for sample preparation, thermal amplification, and signal generation in less than about 25 minutes, without any external instrument.
Stand-alone nucleic-acid detection with internal modules and compact housing
A method of detecting a target nucleic acid using a stand-alone molecular diagnostic test device without any external instrument, comprising conveying an input sample from a sample preparation module to an amplification module fixedly coupled within a housing, heating the input sample via a heater to amplify the target nucleic acid molecule and produce an output solution containing a target amplicon, and reacting within a detection module within the housing the output solution and a reagent formulated to produce a signal indicating a presence of the target amplicon, the detection module including a detection surface configured to capture the target amplicon to produce the signal, the device producing the signal in less than about 25 minutes after the input sample is conveyed from the sample preparation module.
Actuated lysis-to-amplification-to-detection with timed signal generation and disposal
A method of detecting a nucleic acid using a stand-alone molecular diagnostic test device without any external instrument, comprising conveying a biological sample into a sample preparation module; actuating the device to heat the biological sample via a heater of a lysis module to lyse to produce an input sample; conveying the input sample to an amplification module fixedly coupled within the device and heating the input sample within a reaction volume through at least 30 thermal cycles to produce an output solution containing a target amplicon; reacting within a detection module each of the output solution and a reagent formulated to produce a signal indicating a presence of the target amplicon; reading a result associated with the signal; and discarding, after the reading, the stand-alone molecular test device.
The core coverage is a self-contained, in-housing molecular diagnostic workflow that prepares or lyses a biological input, performs heater-based thermal amplification through a reaction volume with at least 30 thermal cycles, and generates a detection signal by reacting the amplified output solution with a formulated reagent and capturing the target amplicon on a detection surface, with signal generation in less than about 25 minutes and no external instrument.
Stated Advantages
Produces the signal in less than about 25 minutes after the input sample is conveyed from the sample preparation module.
Produces the signal in less than about 25 minutes after actuating the stand-alone molecular diagnostic test device.
Enables detection without any external instrument.
Supports a compact device size with an overall housing size less than about 260 cubic centimeters.
Allows discarding the stand-alone molecular test device after reading.
Documented Applications
Detecting target nucleic acid using a stand-alone molecular diagnostic test device without any external instrument, including examples tied to pathogen/amplicon associations and bodily fluids/specimen types explicitly mentioned in dependent claim refinements (e.g., blood, urine, male urethral specimen, vaginal specimen, cervical swab specimen, nasal swab specimen).
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