IP Library Granted Patent US 10,545,161
Granted Patent B2
US 10,545,161 · App. 15/456,326 · Granted Jan 28, 2020

Systems and methods for detection and quantification of analytes

Inventors: Ayub Khattak (San Diego, CA); Clinton Sever (San Diego, CA)
Assignee: CUE HEALTH INC.
G01N35/00871B01L3/502715G01N35/1095B01L2200/027B01L2300/0645B01L2300/0816B01L2300/1827B01L2400/0677G01N2035/0091
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Quick Facts
Patent No.
US 10,545,161
App. No.
15/456,326
Granted
Jan 28, 2020
Kind
B2
Abstract

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. In some embodiments, the reader component communicates with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

Claims (30)

1. A system for generating a signal that detects at least one of a presence, absence, and quantity of one or more analytes, the system comprising:

a sample analysis cartridge comprising:

an input tunnel that extends from an aperture, the input tunnel configured to permit insertion of a distal portion of a sample collection device adapted to be exposed to a sample;

a reservoir configured to hold a liquid and configured to receive the sample from the distal portion of the sample collection device;

an analysis channel configured to receive, from the reservoir, the liquid having the sample and reagents mixed therein; and

an electrochemical sensor configured to be exposed to the mixed liquid in the analysis channel and to generate a signal indicative of at least one of the presence, absence, and quantity of one or more analytes within the sample, the electrochemical sensor comprising a mixture of an oligo-ethyleneglycol dithiol and a carboxylic acid terminated thiol.

2. The system of claim 1 , further comprising a sample analysis reader electrically coupled to the sample analysis cartridge, the sample analysis reader configured to receive the signal for processing and to transmit the processed signal indicative of at least one of the presence, absence, and quantity of the one or more analytes within the sample to a computer; and

a computer readable medium with instructions that, when executed by a processor of the computer, cause a graphical user interface to display information indicative of at least one of the presence, absence, and quantity of the one or more analytes.

3. The system of claim 1 , wherein an oligo-ethylene glycol dithiol is selected from hexa-ethylene glycol diothiol and tetra-ethylene glycol dithiol.

4. The system of claim 1 , wherein the carboxylic acid terminated thiol is 11-mercaptoundecanoic acid.

5. The system of claim 2 , wherein the graphical user interface is generated by an application accessible via the computer.

6. The system of claim 5 , wherein the application is downloadable from the Internet.

7. The system of claim 5 , wherein the application requires a secure login prior to use.

8. The system of claim 2 , wherein the computer is configured to transmit and receive data to and from a server.

9. The system of claim 8 , wherein the data comprises data indicative of at least one of the presence, absence, and quantity of the one or more analytes.

10. The system of claim 8 , wherein the data comprises past test results stored at the server.

11. The system of claim 2 , wherein the information displayed on the graphical user interface comprises a recommendation for user action based on at least one of the presence, absence, and quantity of the one or more analytes.

12. The system of claim 2 , wherein the information displayed on the graphical user interface comprises a table or graph or both based on at least one of the presence, absence, and quantity of the one or more analytes.

13. The system of claim 2 , wherein the computer is configured to receive data from a wearable device, and

wherein the processor of the computer is configured to process the data from the wearable device and to cause the graphical user interface to display information based on the data from the wearable device.

14. The system of claim 5 , wherein the application is configured to sync with a calendar application and to notify a user at particular times based on the synchronization with the calendar application.

15. The system of claim 2 , wherein the application is configured to link to one or more of a user's social networks.

16. The system of claim 15 , wherein the application is configured to notify one or more contacts in the user's one or more social networks of test results indicative of at least one of the presence, absence, and quantity of the one or more analytes within the sample.

17. The system of claim 2 , wherein the application is configured to notify the one or more contacts about test results indicative of fertility levels.

18. The system of claim 15 , wherein the application is configured to anonymously notify the one more contacts in the user's social networks.

19. The system of claim 2 , wherein the instructions, when executed by the processor, cause the graphical user interface to prompt a user to contact a physician or pharmacy or both based on at least one of the presence, absence, and quantity of the one or more analytes.

20. The system of claim 2 , wherein the graphical user interface is configured to display a map indicating positive test results for one or more analytes by other users at locations on the map.

21. The system of claim 2 , wherein the computer comprises a smartphone, a tablet, a wearable device, or a laptop.

22. The system of claim 2 , wherein receipt of the sample analysis cartridge by the sample analysis reader causes electric coupling between the sample analysis cartridge and the sample analysis reader.

23. The system of claim 1 or 2 , wherein the system further comprises the sample collection device.

Assignments (7)
ASSIGNMENT BY BANKRUPTCY Recorded Oct 4, 2024
From: CUE HEALTH INC.
To: SIRO DIAGNOSTICS, INC.
Reel/Frame 070226/0119 →
RELEASE OF SECURITY INTEREST Recorded May 17, 2024
From: EAST WEST BANK, AS COLLATERAL AGENT AND ADMINISTRATIVE AGENT
To: CUE HEALTH INC.
Reel/Frame 067456/0574 →
SECURITY AGREEMENT Recorded Jul 11, 2022
From: CUE HEALTH INC.
To: EAST WEST BANK, AS COLLATERAL AGENT AND ADMINISTRATIVE AGENT
Reel/Frame 060621/0319 →
RELEASE OF SECURITY INTEREST Recorded Jun 25, 2021
From: EAST WEST BANK
To: CUE HEALTH INC.
Reel/Frame 056668/0043 →
SECURITY INTEREST Recorded Apr 9, 2021
From: CUE HEALTH INC.
To: EAST WEST BANK, AS COLLATERAL AND ADMINISTRATIVE AGENT
Reel/Frame 055875/0575 →
MERGER AND CHANGE OF NAME Recorded May 3, 2018
From: CUE INC.; CUE HEALTH INC.
To: CUE HEALTH INC.
Reel/Frame 045711/0743 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 22, 2017
From: KHATTAK, AYUB; SEVER, CLINTON
To: CUE INC.
Reel/Frame 042455/0290 →
Continuity (8)
Continuation In Part 15368249 · Dec 2, 2016
Continuation 14954817 · Nov 30, 2015
Continuation PCTUS2015049439 · Sep 10, 2015
Continuation 14599372 · Jan 16, 2015
Continuation PCTUS2014023821 · Mar 11, 2014
Provisional Application 62049313 · Sep 11, 2014
Provisional Application 61776254 · Mar 11, 2013
Related Publication 20170248622A1 · Aug 31, 2017
Cited By (11)
US 1,063,100 US 1,079,050 US 1,087,801 US 1,101,190 US 1,117,813 US 1,124,400 US 12,208,389 US 12,320,803 US 12,540,915 US 12,546,774 US 12,644,858