IP Library Granted Patent US 11,545,241
Granted Patent B1
US 11,545,241 · App. 14/480,405 · Granted Jan 3, 2023

Systems and methods for analyte testing and data management

Inventors: Elizabeth A. Holmes (Palo Alto, CA); Sunny Balwani (Palo Alto, CA); Daniel Young (San Francisco, CA)
Assignee: Labrador Diagnostics LLC
G16H10/40G06Q10/06311
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Quick Facts
Patent No.
US 11,545,241
App. No.
14/480,405
Granted
Jan 3, 2023
Kind
B1
Abstract

Systems, methods, and devices are provided for clinical laboratory testing using less than 1 mL of sample collected from a subject. Some embodiments collect between 1 mL and about 10 uL of sample from a subject. A method is also provided for analyte testing, wherein a mobile computing device may be used for laboratory test requests and for handling of the analyte testing process.

Claims (26)

1. A method comprising:

clinical laboratory testing using less than 1 mL of sample from a subject comprising:

inserting a cartridge containing the sample and all reagents into a benchtop sample processing device;

using said sample processing device that has on-board controls and wherein the sample processing device is calibrated on a consumable provided by the cartridge;

using a convective flow unit of the sample processing device to thermally maintain a desired air temperature range within substantially light tight confines of the sample processing device, wherein a filtered outlet is provided to filter air exhausting from the sample processing device; and

processing the sample within the light tight, temperature controlled environment of the sample processing device to measure at least one analyte in the sample.

2. A method comprising:

clinical laboratory testing using less than 1 mL but more than 20 μL of sample from a subject comprising:

inserting a cartridge containing the sample and all reagents into a benchtop sample processing device;

using said sample processing device that has on-board controls and wherein the sample processing device is calibrated on a consumable provided by the cartridge;

using a convective flow unit of the sample processing device to thermally maintain a desired air temperature range within substantially light tight confines of the sample processing device, wherein a filtered outlet is provided to filter air exhausting from the sample processing device; and

processing the sample within the light tight, temperature controlled environment of the sample processing device to measure at least one analyte in the sample.

3. A method comprising:

using a mobile computing device to schedule an appointment time for a laboratory test;

displaying a laboratory test menu on the mobile computing device, selecting one or more tests from said test menu, wherein the test menu is variable-based on geographic location; and

using eligibility software to confirm information about a subject and/or subject's coverage before analyte testing is begun and cartridge and/or reagents are opened and/or used;

inserting the cartridge containing the sample and all reagents into a benchtop sample processing device;

using said sample processing device that has on-board controls and wherein the sample processing device is calibrated on a consumable provided by the cartridge;

using a convective flow unit of the sample processing device to thermally maintain a desired air temperature range within substantially light tight confines of the sample processing device, wherein a filtered outlet is provided to filter air exhausting from the sample processing device; and

processing the sample within the light tight, temperature controlled environment of the sample processing device to measure at least one analyte in the sample.

4. The method of claim 1 wherein said clinical laboratory testing is initiated from a consumer ordered laboratory test request.

5. The method of claim 2 wherein said clinical laboratory testing is initiated from a consumer ordered laboratory test request.

6. The method of claim 1 wherein said clinical laboratory testing is initiated from a laboratory test request document scanned by optical character recognition and electronically transmitted to a laboratory where the clinical laboratory testing is to be performed.

7. The method of claim 2 wherein said clinical laboratory testing is initiated from a laboratory test request document scanned by optical character recognition and electronically transmitted to a laboratory where the clinical laboratory testing is to be performed.

8. The method of claim 3 wherein said laboratory test is initiated from a consumer ordered laboratory test request.

9. The method of claim 3 wherein said laboratory test is initiated from a laboratory test request document scanned by optical character recognition and electronically transmitted to a laboratory.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 15, 2022
From: YOUNG, DANIEL
To: THERANOS, INC.
Reel/Frame 059273/0393 →
CHANGE OF NAME Recorded Apr 15, 2020
From: THERANOS IP COMPANY, LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052410/0432 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 16, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 045075/0310 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2017
From: THERANOS INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 044838/0909 →
SECURITY INTEREST Recorded Dec 12, 2017
From: THERANOS IP COMPANY, LLC
To: FORTRESS CREDIT CORP.
Reel/Frame 044839/0568 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 29, 2017
From: HOLMES, ELIZABETH A.; BALWANI, SUNNY
To: THERANOS, INC.
Reel/Frame 044532/0205 →
Continuity (2)
Provisional Application 61875033 · Sep 7, 2013
Provisional Application 61875687 · Sep 9, 2013
Cited By (1)
US 12,718,913