Molecular diagnostic devices with digital detection capability and wireless connectivity
Inventors
ABRAHAM, Teresa • Briones, Victor • Ciopyk, Brian • Dentinger, Paul • KAJOUKE, Kamal • KNYSH, Bryan D. • MA, Brandon
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
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-12263478-B2
Publication Date
2025-04-01
Expiration Date
Abstract
In some embodiments, a stand-alone molecular diagnostic test device includes a detection circuit that includes a light emitting device and a light receiving device (e.g., a photodiode) that are arranged to produce an electronic signal associated with a colorimetric output produced by the stand-alone molecular diagnostic test.
Core Innovation
The invention provides a disposable stand-alone molecular diagnostic test device with a housing that defines an input opening through which a biological sample can be conveyed, and a detection module within the housing that defines a detection volume into which the biological sample can be conveyed. A reagent within the housing is formulated to facilitate production of an assay signal indicating a presence of a target polynucleotide sequence within the biological sample. The device includes an electronic system within the housing with a photodetector assembly, memory, a processing device, and a digital read module.
The electronic system receives a first light signal for a first time period before the biological sample and the reagent are reacted within the detection volume, determines a first magnitude associated with the first light signal, receives a second light signal for a second time period after the biological sample and the reagent are reacted, and determines a second magnitude associated with the second light signal. The electronic system determines, based on a comparison of the first magnitude and the second magnitude, whether the target polynucleotide sequence is present in the biological sample and produces an electronic output when the target polynucleotide sequence is determined to be present.
In related device and method forms, the assay signal is a colorimetric signal, and the system determines magnitudes of light signals using a digital read module to indicate whether the colorimetric signal is present in the detection volume. Time-separated measurements can be evaluated using slope differences or other magnitude metrics such as intensity, slope, or variability, and the comparison is used to produce an electronic output. In some implementations, the device communicates an indication of assay signal presence to a computing device using radio and a short-range wireless communication protocol, and supports connected health workflows including EHR integration and telemedicine support [procedural detail omitted for safety].
Claims Coverage
Independent claims identified: clm-00001, clm-00008, clm-00013, clm-00021, and clm-00025. Across these, the inventive features focus on a stand-alone molecular diagnostic device and computer-implemented methods that use time-separated photodetector measurements, magnitude determination, and comparison to produce an electronic output indicating presence of a target polynucleotide sequence, including colorimetric signals, reference polynucleotide signals, and wireless communication.
Time-separated photodetector magnitudes for target presence
A molecular diagnostic test device includes an electronic system with a photodetector assembly and a digital read module configured to receive a first light signal for a first time period before reaction, determine a first magnitude, receive a second light signal for a second time period after reaction, determine a second magnitude, and determine based on a comparison of the first magnitude and the second magnitude whether the target polynucleotide sequence is present, producing an electronic output when the target is present.
Reference-polynucleotide assay signals with magnitude comparison
A computer-implemented method detects a presence of a target polynucleotide sequence by receiving a first light signal associated with a first assay signal indicating target presence and a second assay signal indicating reference polynucleotide sequence presence, determining a first magnitude, receiving a second light signal associated with the second assay signal, determining a second magnitude, and producing an electronic output when a comparison indicates the target polynucleotide sequence is present.
Colorimetric signal detection using light-assembly and photodetector magnitude
A molecular diagnostic test device includes a reagent formulated to facilitate production of a colorimetric signal indicating presence of a target polynucleotide sequence, and an electronic system including a light assembly and a photodetector assembly positioned to receive a light signal associated with reflection or attenuation; a digital read module determines a magnitude of the light signal and produces an indication, based on the magnitude, whether the colorimetric signal is present in the detection volume.
Slope-based determination with predetermined threshold
A computer-implemented method receives first and second light signals for respective time periods, determines a first slope and a second slope of the first and second light signals, and produces an electronic output indicating presence of the colorimetric signal when a slope difference between the first slope and the second slope exceeds a predetermined slope threshold.
Sensor-signal metrics with short-range wireless transmission
A molecular diagnostic test device includes a sensor configured to produce a sensor signal associated with the assay signal, and a digital read module configured to determine whether the assay signal is present based on at least one of intensity, slope, or variability of the sensor signal; the device further includes a radio configured to electronically communicate with a computing device via a short-range wireless communication protocol and to send a wireless signal indicating whether the assay signal is present.
The independent claims collectively cover a molecular diagnostic test device and computer-implemented methods that measure light or sensor signals at different time periods or compute signal metrics, compare computed values, and produce an electronic output indicating presence of a target polynucleotide sequence, with some claim sets emphasizing colorimetric signals, reference polynucleotide signals, and short-range wireless communication.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
Interested in licensing this patent?