IP Library Granted Patent US 10,557,863
Granted Patent B2
US 10,557,863 · App. 14/789,930 · Granted Feb 11, 2020

Systems and methods for multi-analysis

Inventors: Elizabeth A. Holmes (Palo Alto, CA); Michael Chen (Palo Alto, CA); John K. Frankovich (Palo Alto, CA); Samartha Anekal (Palo Alto, CA); Adrit Lath (Palo Alto, CA); Alexander Loo (Palo Alto, CA); Chinmay Pangarkar (Palo Alto, CA); Joy Roy (Palo Alto, CA); Timothy Smith (Palo Alto, CA); Daniel Young (Palo Alto, CA)
Assignee: Theranos IP Company, LLC
G01N35/0092B01L3/021B01L3/5082B01L3/50855B01L7/52B01L9/06B01L9/543C12Q1/42C12Q1/52C12Q1/6883C12Q1/70G01N15/1475G01N21/25G01N21/27G01N33/54306G01N33/54313G01N33/54366G01N33/56983G01N33/62G01N33/6827G01N33/80G01N33/92G01N35/00029G01N35/00069G01N35/00623G01N35/00871G01N35/026G01N35/04G01N35/10G01N35/1009G01N35/1011G01N35/1065G01N35/1072B01L9/52B01L2300/1827B01L2300/1855G01N33/5005G01N35/00G01N2015/008G01N2015/0073G01N2015/1006G01N2015/1486G01N2035/00138G01N2035/00148G01N2035/00237G01N2035/00306G01N2035/00326G01N2035/00356G01N2035/00366G01N2035/00425G01N2035/00435G01N2035/00495G01N2035/00633G01N2035/0449G01N2035/0474G01N2035/0486G01N2035/0491G01N2035/0493G01N2035/0494G01N2201/024G01N2201/04G01N2201/12Y10T436/111666Y10T436/113332
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Quick Facts
Patent No.
US 10,557,863
App. No.
14/789,930
Granted
Feb 11, 2020
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 (45)

1. A biological sample processing system comprising:

an insertable and removable cartridge comprising:

at least one receptacle for receiving a blood sample obtained by a fingerstick from a subject,

at least one assay unit for performing a nucleic acid amplification assay to detect a nucleic acid from the blood sample,

at least a second assay unit for performing another assay on a portion of the blood sample, wherein said another assay does not involve nucleic acid amplification; and

all reagents for performing the nucleic acid amplification assay and said another assay;

and a biological sample processing device comprising:

a housing containing the following:

a cartridge receiving location,

a nucleic acid assay assembly comprising at least one light source, a thermal device comprising a temperature control for the nucleic acid amplification assay, and at least one detector for detecting the nucleic acid;

at least a second detector for use in performing said another assay;

a sample handling system for transporting the blood sample to the at least one assay unit and the at least one assay unit to the detector; and

an airflow unit configured to provide a controlled air-flow environment within said housing;

wherein the at least one light source is mounted on a movable portion of the nucleic acid assay assembly that is movable to cover or uncover a portion of the thermal device.

2. The system of claim 1 , further comprising a centrifuge.

3. The system of claim 1 , wherein the thermal device provides thermocycling for the nucleic acid amplification.

4. The system of claim 1 , wherein the nucleic acid amplification is isothermal amplification.

5. The system of claim 1 , wherein the nucleic acid is a nucleic acid from a virus.

6. The system of claim 5 , wherein the virus is selected from measles, mumps, rubella, poliomyelitis, hepatitis A, hepatitis B, hepatitis C, hepatitis delta, hepatitis E, influenza, adenovirus, rabies, yellow fever, Epstein-Barr virus, papillomavirus, Ebola virus, Japanese encephalitis, dengue virus, hantavirus, Sendai virus, respiratory syncytial virus, othromyxovirus, vesicular stomatitis virus, visna virus, cytometalovirus, human immunodeficiency virus, and herpes simplex virus.

7. A biological sample processing device comprising:

an insertable and removable cartridge comprising:

a blood sample obtained by a fingerstick from a subject, at least one assay unit for performing a nucleic acid amplification assay to detect a nucleic acid from the blood sample,

at least a second assay unit for performing another assay on a portion of the blood sample, wherein said another assay does not involve nucleic acid amplification, and

all reagents for performing the nucleic acid amplification assay and said another assay;

a housing containing the following:

a nucleic acid assay assembly comprising at least one light source, a thermal device comprising a temperature control for the nucleic acid amplification assay, and at least one detector for detecting the nucleic acid;

at least a second detector for use in performing said another assay;

a sample handling system for transporting (i) the blood sample to the at least one assay unit and the second assay unit; (ii) the at least one assay unit to the detector for detecting the nucleic acid; and (iii) the second assay unit to the second detector; and

an airflow unit configured to provide a controlled air-flow environment within said housing;

wherein the at least one light source is mounted on a movable portion of the nucleic acid assay assembly that is movable to cover or uncover a portion of the thermal device.

8. The device of claim 7 , further comprising a centrifuge.

9. The device of claim 7 , wherein the thermal device provides thermocycling for the nucleic acid amplification.

10. The device of claim 7 , wherein the nucleic acid is a nucleic acid from a virus.

11. A biological sample processing device comprising:

an insertable and removable cartridge comprising:

a blood sample obtained by a fingerstick from a subject, at least one assay unit for performing a nucleic acid amplification assay to detect a nucleic acid from the blood sample,

at least a second assay unit for performing another assay on a portion of the blood sample, wherein said another assay does not involve nucleic acid amplification, and

all reagents for performing the nucleic acid amplification assay and said another assay;

a housing containing the following:

a nucleic acid assay assembly comprising at least one light source, a thermal device comprising a temperature control for the nucleic acid amplification assay, and at least one detector for detecting the nucleic acid;

at least a second detector for use in performing said another assay;

a sample handling system for transporting (i) the blood sample to the at least one assay unit and the second assay unit; (ii) the at least one assay unit to the detector for detecting the nucleic acid; and (iii) the second assay unit to the second detector; and

an airflow unit configured to provide a controlled air-flow environment within said housing;

wherein the at least one light source is mounted on a movable portion of the nucleic acid assay assembly that is movable to cover or uncover a portion of the thermal device;

wherein the thermal device and at least one detector for detecting the nucleic acid are combined in a single assembly with at least one light source located in the movable portion of the nucleic acid assay assembly positionable so that the light source is in-line with a well of the thermal device holding the at least one assay unit.

Assignments (5)
CHANGE OF NAME Recorded Apr 3, 2020
From: THERANOS IP COMPANY, LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052313/0011 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 045205/0686 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 24, 2018
From: BALWANI, SUNNY; LATH, ADRIT; GANGAKHEDKAR, SUREKHA; LOO, ALEXANDER; CHEN, MICHAEL; PANGARKAR, CHINMAY; YOUNG, DANIEL; HOLMES, ELIZABETH A.; FRENZEL, GARY; FRANKOVICH, JOHN K.; ROY, JOY; PATEL, PAUL; ANEKAL, SAMARTHA; SMITH, TIMOTHY; GIBBONS, IAN
To: THERANOS, INC.
Reel/Frame 045140/0574 →
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 →
Continuity (18)
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
Provisional Application 61766113 · Feb 18, 2013
Provisional Application 61766119 · Feb 18, 2013
Related Publication 20150368717A1 · Dec 24, 2015
Cited By (1)
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