IP Library Granted Patent US 12,085,583
Granted Patent B2
US 12,085,583 · App. 17/319,842 · Granted Sep 10, 2024

Systems and methods for multi-analysis

Inventors: Elizabeth A. Holmes (Palo Alto, CA); Michael Chen (Sunnyvale, CA); Pey-Jiun Ko (Redwood City, CA)
Assignee: Labrador Diagnostics LLC
G01N35/0092B01L3/021B01L3/5027B01L3/5082B01L3/50855B01L7/52B01L9/06B01L9/543C12Q1/42C12Q1/52C12Q1/6883C12Q1/70G01N15/1433G01N21/25G01N21/27G01N33/54306G01N33/54313G01N33/54366G01N33/56972G01N33/56983G01N33/62G01N33/6827G01N33/80G01N33/92G01N35/00029G01N35/00069G01N35/00623G01N35/00871G01N35/026G01N35/04G01N35/10G01N35/1009G01N35/1011G01N35/1065G01N35/1072B01L9/52B01L2300/1827B01L2300/1855G01N2015/012G01N2015/016G01N2015/1006G01N2015/1486G01N33/5005G01N35/00G01N2035/00138G01N2035/00148G01N2035/00237G01N2035/00306G01N2035/00326G01N2035/00356G01N2035/00366G01N2035/00425G01N2035/00435G01N2035/00495G01N2035/00633G01N2035/0449G01N2035/0474G01N2035/0486G01N2035/0491G01N2035/0493G01N2035/0494G01N2201/024G01N2201/04G01N2201/12Y10T436/111666Y10T436/113332
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Quick Facts
Patent No.
US 12,085,583
App. No.
17/319,842
Granted
Sep 10, 2024
Kind
B2
Abstract

Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.

Claims (31)

1. A method of performing two or more assays for detecting a plurality of analytes in a biological sample from a subject, comprising:

receiving the biological sample in a biological sample processing system, wherein

the biological sample processing system comprises:

a sample handling system;

a plurality of assay units for performing said two or more assays to detect a plurality of analytes in the biological sample, and

at least two detection units;

receiving a cartridge in the biological sample processing system, the cartridge comprising a plurality of vessels;

executing, by a computer, a command to a controller to facilitate aliquoting of the two or more assays;

aliquoting at least a diluted portion of the sample into one of the plurality of assay units of the biological sample processing system while the cartridge remains inside the biological sample processing system;

decoupling one or more vessels from the cartridge while the cartridge remains inside the biological sample processing system to form one or more decoupled components;

using a centrifuge on one of said assay units;

performing in the biological sample processing system two or more assays using the plurality of assay units; and

detecting the plurality of analytes with at least one of a plurality of detection units in the biological sample processing system.

2. The method of claim 1 , wherein the biological sample is a blood sample.

3. The method of claim 2 , wherein the two or more assays are performed from a single blood sample obtained from the subject.

4. The method of claim 2 , wherein the blood sample is a plasma sample.

5. The method of claim 1 , wherein the biological sample processing system comprises at least three assay units and performs three or more assays at least partially in parallel, wherein the three or more assays comprise a nucleic acid amplification, an immunoassay, and a cytometric assay, and wherein the plurality of analytes comprise an antibody, an antigen, a nucleic acid, and a cell.

6. The method of claim 5 , wherein the biological sample processing system further comprises a cytometer.

7. The method of claim 1 , wherein the biological sample processing system further comprises a centrifuge.

8. The method of claim 1 , wherein the biological sample processing system further comprises a housing.

9. The method of claim 8 , wherein the cartridge comprises at least one thermal heating unit.

10. The method of claim 9 , wherein the cartridge further comprises at least one tip, and wherein a sample handling system of the biological sample processing system comprises at least one pipette nozzle configured to engage with the at least one tip.

11. The method of claim 1 , where the cartridge is provided in a refrigerated condition in a temperature in the range of about −20° ° C. to about 8° C. range for days to weeks.

12. The method of claim 11 , where the cartridge in the refrigerated condition has temperature in the range of about 2° ° C. to about 8° C. range for days to weeks.

13. The method of claim 11 , where the cartridge in the refrigerated condition has temperature in the range of about 0° ° C. to about 8° C. range for days to weeks.

14. The method of claim 1 , further comprising a heater mounted below a cartridge receiving location in the biological sample processing system.

15. The method of claim 14 , wherein the heater comprises thermoelectric device.

16. The method of claim 15 , wherein the heater further comprises a fan.

17. The method of claim 15 , wherein the heater further comprises a plurality of holes sized to engage portions of vessels in the cartridge.

18. The method of claim 15 , wherein the heater is configured to direct heat towards an underside of the cartridge when the cartridge is in a cartridge receiving location.

19. The method of claim 15 , wherein heater is configured to direct heat directly towards only a portion of an underside of the cartridge when the cartridge is in a cartridge receiving location.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 13, 2021
From: HOLMES, ELIZABETH A.; CHEN, MICHAEL; KO, PEY-JIUN
To: THERANOS, INC.
Reel/Frame 056239/0511 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 13, 2021
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 056239/0919 →
CHANGE OF NAME Recorded May 13, 2021
From: THERANOS IP COMPANY, LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 056239/0974 →
Continuity (39)
Continuation 14860048 · Sep 21, 2015
Continuation 14789930 · Jul 1, 2015
Continuation 14183500 · Feb 18, 2014
Continuation 14183503 · Feb 18, 2014
Continuation In Part 13769779 · Feb 18, 2013
Continuation In Part 13769820 · Feb 18, 2013
Continuation In Part PCTUS2012057155 · Sep 25, 2012
Continuation In Part PCTUS2011053188 · Sep 25, 2011
Continuation In Part PCTUS2011053189 · Sep 25, 2011
Continuation In Part 13244947 · Sep 26, 2011
Continuation In Part 13244946 · Sep 26, 2011
Continuation In Part 13244949 · Sep 26, 2011
Continuation In Part 13244956 · Sep 26, 2011
Continuation In Part 13244952 · Sep 26, 2011
Continuation In Part 13244950 · Sep 26, 2011
Continuation In Part 13244953 · Sep 26, 2011
Continuation In Part 13244954 · Sep 26, 2011
Continuation In Part PCTUS2011053188 · Sep 25, 2011
Continuation In Part PCTUS2011053189 · Sep 25, 2011
Continuation In Part 13244947 · Sep 26, 2011
Continuation In Part 13244946 · Sep 26, 2011
Continuation In Part PCTUS2012057155 · Sep 25, 2012
Continuation In Part PCTUS2011053188 · Sep 25, 2011
Continuation In Part PCTUS2011053189 · Sep 25, 2011
Continuation In Part 13244947 · Sep 26, 2011
Continuation In Part 13244946 · Sep 26, 2011
Continuation In Part 13244949 · Sep 26, 2011
Continuation In Part 13244956 · Sep 26, 2011
Continuation In Part 13244952 · Sep 26, 2011
Continuation In Part 13244950 · Sep 26, 2011
Continuation In Part 13244953 · Sep 26, 2011
Continuation In Part 13244954 · Sep 26, 2011
Continuation In Part PCTUS2011053188 · Sep 25, 2011
Continuation In Part PCTUS2011053189 · Sep 25, 2011
Continuation In Part 13244947 · Sep 26, 2011
Continuation In Part 13244946 · Sep 26, 2011
Provisional Application 61766119 · Feb 18, 2013
Provisional Application 61766113 · Feb 18, 2013
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