IP Library › Granted Patent US 12,263,478
Granted Patent B2
US 12,263,478 · App. 17/606,669 · Granted Apr 1, 2025

Molecular diagnostic devices with digital detection capability and wireless connectivity

Inventors: Teresa Abraham (Washington, DC); Victor Briones (Gilroy, CA); Brian Ciopyk (Santa Clara, CA); Paul Dentinger (Sunol, CA); Kamal Kajouke (San Jose, CA); Bryan D. Knysh (Toronto, CA); Brandon Ma (Santa Clara, CA)
Assignee: Visby Medical, Inc.
B01L3/502715C12Q1/6825G16B20/00G16B25/20G16B40/10B01L2200/16B01L2300/04B01L2300/0663B01L2300/0809
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Quick Facts
Patent No.
US 12,263,478
App. No.
17/606,669
Granted
Apr 1, 2025
Kind
B2
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.

Claims (108)

1. A molecular diagnostic test device, comprising:

a housing defining an input opening through which a biological sample can be conveyed;

a detection module within the housing, the detection module defining a detection volume into which the biological sample can be conveyed;

a reagent within the housing, the reagent formulated to facilitate production of an assay signal indicating a presence of a target polynucleotide sequence within the biological sample; and

an electronic system within the housing, the electronic system including a photodetector assembly, a memory, a processing device and a digital read module implemented in at least one of the memory or the processing device, the digital read module configured to:

receive, from the photodetector assembly, a first light signal for a first time period before the biological sample and a reagent are reacted within the detection volume;

determine a first magnitude associated with the first light signal during the first time period;

receive, from the photodetector assembly, a second light signal for a second time period after the biological sample and the reagent are reacted within the detection volume of the detection module, the second light signal associated with the assay signal;

determine a second magnitude associated with the second light signal during the second time period; and

determine, based on a comparison of the first magnitude and the second magnitude, whether the target polynucleotide sequence is present in the biological sample; the electronic system configured to produce an electronic output when the target polynucleotide sequence is determined to be present in the biological sample.

2. The molecular diagnostic test device of claim 1 , wherein:

the first magnitude is any one of a slope of the first light signal during the first time period or an average intensity of the first light signal during the first time period; and

the second magnitude is any one of a slope of the second light signal during the second time period or an average intensity of the second light signal during the second time period.

3. The molecular diagnostic test device of claim 1 , wherein:

the housing defines a status opening; and

the electronic system includes a light output device configured to produce the electronic output, which is a light output, the light output being visible via the status opening.

4. The molecular diagnostic test device of claim 1 , wherein:

the assay signal is a first assay signal;

the reagent is formulated to facilitate production of a second assay signal indicating the presence of a reference polynucleotide sequence; and

the digital read module is further configured to:

receive, from the photodetector assembly, a third light signal for a third time period after the biological sample and the reagent are reacted within the detection volume of the detection module, the third light signal associated with the second assay signal;

determine a third magnitude associated with the third light signal during the third time period; and

determine, based on a comparison of the second magnitude and the third magnitude, whether the target polynucleotide sequence is present in the biological sample.

5. The molecular diagnostic test device of claim 4 , wherein:

the reference polynucleotide sequence comprises at least one of a control polynucleotide sequence or an invariant polynucleotide sequence associated with the target polynucleotide sequence.

6. The molecular diagnostic test device of claim 1 , wherein:

the assay signal is a colorimetric signal;

the detection module includes a detection surface, the colorimetric signal being produced at the detection surface; and

the electronic system includes a light source, the light source configured to produce a first light beam through the detection module at the detection surface during the first time period and a second light beam through the detection module at the detection surface during the second time period, the first magnitude associated with a first attenuation of the first light beam, the second magnitude associated with a second attenuation of the second light beam.

7. The molecular diagnostic test device of claim 6 , wherein:

the detection module includes a probe adhered to the detection surface, the probe designed to bind an amplicon associated with the target polynucleotide sequence, the colorimetric signal being produced from the detection surface.

8. A computer-implemented method of detecting a presence of a target polynucleotide sequence within a biological sample, the method performed by a molecular diagnostic test device including an electronic system and a detection module, the method comprising:

receiving, at a photodetector assembly of the electronic system, a first light signal for a first time period after the biological sample and a reagent are reacted within a detection volume of the detection module, the reagent formulated to facilitate production of a first assay signal and a second assay signal, the first assay signal indicating the presence of the target polynucleotide sequence, the second assay signal indicating the presence of a reference polynucleotide sequence, the first light signal associated with the first assay signal;

determining a first magnitude associated with the first light signal during the first time period;

receiving, at the photodetector assembly, a second light signal for a second time period after the biological sample and the reagent are reacted within the detection volume of the detection module, the second light signal associated with the second assay signal;

determining a second magnitude associated with the second light signal during the second time period; and

producing an electronic output when a comparison of the first magnitude and the second magnitude indicates that the target polynucleotide sequence is present.

9. The computer-implemented method of claim 8 , wherein:

the first magnitude is any one of a slope of the first light signal during the first time period or an average intensity of the first light signal during the first time period; and

the second magnitude is any one of a slope of the second light signal during the second time period or an average intensity of the second light signal during the second time period.

10. The computer-implemented method of claim 8 , wherein the determining the first magnitude, the determining the second magnitude, and the comparing of the first magnitude and the second magnitude are performed in a digital read module implemented in at least one of a memory or a processing device of the electronic system.

11. The computer-implemented method of claim 8 , wherein:

the first assay signal is any one of a colorimetric signal, a chemiluminescence signal, or a fluorescence signal.

12. The computer-implemented method of claim 8 , wherein:

the detection module includes a first detection surface and a second detection surface;

the first assay signal is a first colorimetric signal produced at the first detection surface, the first light signal being associated with a first light beam conveyed through the first detection surface, the first magnitude associated with a first attenuation of the first light beam; and

the second assay signal is a second colorimetric signal produced at the second detection surface, the second light signal being associated with a second light beam conveyed through the second detection surface, the second magnitude associated with a second attenuation of the second light beam.

13. A molecular diagnostic test device, comprising:

a housing defining an input opening through which a biological sample can be conveyed;

a detection module within the housing, the detection module defining a detection volume into which the biological sample can be conveyed;

a reagent within the housing, the reagent formulated to facilitate production of a colorimetric signal within the detection module after the biological sample and the reagent are reacted within the detection volume, the colorimetric signal indicating a presence of a target polynucleotide sequence within the biological sample; and

an electronic system within the housing, the electronic system including a light assembly, a photodetector assembly, a memory, a processing device and a digital read module implemented in at least one of the memory or the processing device,

the light assembly positioned on a first side of the detection module, the light assembly configured to produce a light beam that passes through detection volume of the detection module;

the photodetector assembly positioned on the first side of the detection module, the photodetector assembly configured to receive a light signal, the light signal associated with any of a reflection or an attenuation of the light beam; and

the digital read module configured to determine a magnitude of the light signal and produce, based on the magnitude, an indication whether the colorimetric signal is present in the detection volume.

14. The molecular diagnostic test device of claim 13 , wherein:

the light signal is a first light signal;

the magnitude is a first magnitude; and

the digital read module is configured to:

receive, from the photodetector assembly, the first light signal for a first time period before the biological sample and the reagent are reacted within the detection volume;

determine the first magnitude associated with the first light signal during the first time period;

receive, from the photodetector assembly, a second light signal for a second time period after the biological sample and the reagent are reacted within the detection volume of the detection module, the second light signal associated with the colorimetric signal; and

determine a second magnitude associated with the second light signal during the second time period; and

determine, based on a comparison of the first magnitude and the second magnitude, whether the colorimetric signal is present in the detection volume.

15. The molecular diagnostic test device of claim 13 , wherein the electronic system is configured to produce any one of a light output, an audible output, a wireless signal, or a haptic output based on the indication whether the colorimetric signal is present in the detection volume.

16. The molecular diagnostic test device of claim 13 , wherein:

the detection module includes a detection flow cell that includes a reflective portion on a second side of the detection module, the reflective portion configured to reflect the light beam produced by the light assembly positioned on the first side of the detection module back towards the photodetector assembly positioned on the first side of the detection module.

17. The molecular diagnostic test device of claim 16 , wherein:

the detection flow cell includes a light-blocking portion on a third side of the detection module, the third side of the detection module being nonparallel to the first side and the second side.

18. The molecular diagnostic test device of claim 13 , wherein:

the colorimetric signal is a first colorimetric signal;

the light signal is a first light signal;

the light beam is a first light beam;

the magnitude is a first magnitude; and

the detection module includes a first detection surface and a second detection surface, the first colorimetric signal being produced at the first detection surface, the reagent formulated to facilitate production of a second colorimetric signal at the second detection surface after the biological sample and the reagent are reacted within the detection volume, the second colorimetric signal indicating the presence of a reference polynucleotide sequence;

the light assembly is configured to produce the first light beam and a second light beam, the first light beam incident upon the first detection surface, the second light beam incident upon the second detection surface;

the photodetector assembly is configured to receive the first light signal and a second light signal, the first light signal associated with any of the reflection or the attenuation of the first light beam, the second light signal associated with any of a reflection or an attenuation of the second light beam; and

the digital read module is configured to determine a second magnitude of the second light signal.

19. The molecular diagnostic test device of claim 18 , wherein:

a first detection envelope is defined about the first detection surface, the first light beam and the first light signal each being within the first detection envelope; and

a second detection envelope is defined about the second detection surface, the second light beam and the second light signal each being within the second detection envelope;

the molecular diagnostic test device further comprising:

a light shield between the first detection envelope and the second detection envelope.

20. The molecular diagnostic test device of claim 19 , wherein:

the housing defines a status opening;

the electronic system includes a light output device configured to produce a light output visible via the status opening; and

the light shield is a first light shield;

the molecular diagnostic test device further comprising:

a second light shield surrounding at least a portion of the light output device.

21. A computer-implemented method of detecting a presence of a colorimetric signal produced by a molecular diagnostic test device to indicate the presence of a target polynucleotide sequence within a biological sample, the method comprising:

receiving, at a photodetector of an electronic system of the molecular diagnostic test device, a first light signal for a first time period before the biological sample and a reagent are reacted within a detection volume of a detection module of the molecular diagnostic test device, the reagent formulated to facilitate production of the colorimetric signal within the detection volume, the colorimetric signal indicating the presence of the target polynucleotide sequence, the first light signal associated with a light beam conveyed through the detection module and into the detection volume;

determining a first slope of the first light signal during the first time period;

receiving, at the photodetector, a second light signal for a second time period after the biological sample and the reagent are reacted within the detection volume of the detection module, the second light signal associated with the light beam conveyed through the detection module and into the detection volume;

determining a second slope of the second light signal during the second time period; and

producing an electronic output indicating the presence of the colorimetric signal when a slope difference between the first slope and the second slope exceeds a predetermined slope threshold.

22. The computer-implemented method of claim 21 , wherein the determining the first slope and the determining the second slope is performed in a digital read module implemented in at least one of a memory or a processing device of the electronic system.

23. The computer-implemented method of claim 21 , wherein the first light signal and the second light signal are each associated with an attenuation of the light beam through the detection volume of the detection module.

24. The method of claim 21 , wherein:

a housing defines a status opening; and

the electronic output includes a light output, the light output being visible via the status opening.

25. A molecular diagnostic test device, comprising:

a housing defining an input opening through which a biological sample can be conveyed;

a detection module within the housing, the detection module defining a detection volume into which the biological sample can be conveyed;

a reagent within the housing, the reagent formulated to facilitate production of an assay signal within the detection module after the biological sample and the reagent are reacted within the detection volume, the assay signal indicating a presence of a target polynucleotide sequence within the biological sample; and

an electronic system within the housing, the electronic system including:

a sensor configured to produce a sensor signal associated with the assay signal;

a digital read module implemented in at least one of a memory or a processing device, the digital read module configured to determine, based on at least one of an intensity of the sensor signal, a slope of the sensor signal, or a variability of the sensor signal, whether the assay signal is present in the detection volume; and

a radio configured to electronically communicate with a computing device via a short-range wireless communication protocol, the radio sending a first wireless signal to establish a communications link between the computing device and the molecular diagnostic test device, the radio sending a second wireless signal indicating whether the assay signal is present.

Assignments (2)
SECURITY INTEREST Recorded Mar 7, 2025
From: VISBY MEDICAL, INC.
To: ANKURA TRUST COMPANY, LLC
Reel/Frame 070442/0884 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 27, 2021
From: ABRAHAM, TERESA; BRIONES, VICTOR; CIOPYK, BRIAN; DENTINGER, PAUL; KAJOUKE, KAMAL; KNYSH, BRYAN D.; MA, BRANDON
To: VISBY MEDICAL, INC.
Reel/Frame 057937/0907 →
Continuity (3)
Provisional Application 62957068 · Jan 3, 2020
Provisional Application 62839724 · Apr 28, 2019
Related Publication 20220203365A1 · Jun 30, 2022
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