Systems and methods for collecting and transmitting assay results

• US 9,858,660 B2
• Filed: 02/15/2013
• Issued: 01/02/2018
• Est. Priority Date: 09/25/2011
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (FIG LLC (d/b/a Fortress Investment Group LLC))
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth A.
• Primary Examiner(s): Chng, Joy
• Application Number:
  US13/768,748
• Publication Number:
  US 20130156286A1
• Time in Patent Office: 1,782 Days
• Field of Search: 705 2- 3
• CPC Class Codes: G06F 15/16 Combinations of two or more digital computers each having at least an arithmetic unit, a program unit and a register, e.g. for a simultaneous processing of several programs coordinating program control therefor G06F9/52; in regulating and control system G05B
• CPC Class Codes: G06T 7/0012 Biomedical image inspection

Abstract

Systems and methods are provided for collecting, preparing, and/or analyzing a biological sample. A sample collection site may be utilized with one or more sample processing device. The sample processing device may be configured to accept a sample from a subject. The sample processing device may perform one or more sample preparation step and/or chemical reaction involving the sample. Data related to the sample may be sent from the device to a laboratory. The laboratory may be a certified laboratory that may generate a report that is transmitted to a health care professional. The health care professional may rely on the report for diagnosing, treating, and/or preventing a disease in the subject.

Claims

1. A method of evaluating a biological sample collected from a subject, said method comprising:

Obtaining raw data at a designated sample collection site, said designated sample collection site being separate from a laboratory location, said raw data obtained from said biological sample using

a device having a housing, said device placed at said designated sample collection site said biological sample comprising a cell, wherein the device comprises a sample preparation unit in the housing comprising (i) a pipette, and ii) a centrifuge, a thermal controller, and a cytometer, wherein the device is configured to process the biological sample within said housing by;

(i) receiving the biological sample at said designated sample collection site, wherein said biological sample is provided to the device in a cartridge, said cartridge containing a disposable component and all reagents used in processing the biological sample;

(ii) preparing the biological sample and yielding raw data from multiplexed assays performed on a single sample within said housing for a subsequent qualitative and/or quantitative evaluation of said biological sample, wherein said raw data comprises (1) numerical values representative of a physical process or chemical reaction performed by the device and (2) electronic data representative of an image of a cell in said biological sample; and

(iii) transmitting electronically the raw data from said designated sample collection site to said laboratory location for performance of said subsequent evaluation at said laboratory location;

Then;

(a) receiving said raw data at said laboratory location separate from said designated sample collection site;

then

(b) analyzing the raw data at the laboratory location, to provide said evaluation of said biological sample, wherein said analysis is performed using a processor alone or in conjunction with an individual affiliated with the laboratory; and

(c) providing oversight of integrity of said analysis and operation of said device such that results generated from said analysis can be utilized by a health care professional for diagnosis or treatment of said subject, wherein the oversight is performed at the laboratory location using a processor alone or in conjunction with an individual affiliated with the laboratory.

2. The method of claim 1, wherein preparing the biological sample and yielding raw data within said housing comprises transporting a reagent, the biological sample, or a portion of the biological sample, with a pipette within said housing.

3. The method of claim 1, wherein preparing the biological sample and yielding raw data within said housing comprises centrifuging the biological sample, or a portion thereof, within said housing.

4. The method of claim 1, wherein the authorized analytical facility is a Clinical Laboratory Improvement Amendments (CLIA)-compliant laboratory.

5. The method of claim 1, wherein said designated sample collection site is a site selected from the group consisting of a retailer site, the subject'"'"'s home, a health assessment location, and a health treatment location.

6. The method of claim 1, wherein said electronic data representative of an image of a cell in said biological sample comprises electronic data derived from an optical assessment of histology of said cell, morphology of said cell, hematology, or cell count.

7. The method of claim 1, wherein receiving data comprises receiving data from an image of a physical process or chemical reaction performed by the device with said biological sample or a portion thereof.

8. The method of claim 1, wherein preparing the biological sample and yielding raw data within said housing comprises yielding raw data within said housing from at least two assays selected from an immunoassay, a nucleic acid assay, a receptor-based assay, and an enzymatic assay.

9. The method of claim 1, wherein the evaluation of said biological sample is effected without transporting said biological sample from the designated sample collection site to the laboratory location.

10. The method of claim 1, wherein the biological sample is selected from the group consisting of blood, serum, plasma, nasal swab, nasopharyngeal wash, saliva, urine, tears, gastric fluid, spinal fluid, stool, mucus, sweat, earwax, oil, glandular secretion, cerebral spinal fluid, tissue, semen, vaginal fluid, throat swab, breath, hair, finger nails, skin, biopsy, placental fluid, amniotic fluid, cord blood, lymphatic fluids, cavity fluids, sputum, mucus, pus, microbiota, meconium, breast milk and other excretions.

11. The method of claim 1, wherein the biological sample is a fluid sample having a volume of 250 μ

L or less.

12. The method of claim 1, wherein said oversight includes the selection of analysis methodology and procedures.

13. The method of claim 1, further comprising the step of verifying insurance eligibility of said subject prior to, concurrent with or subsequent to said analysis.

14. The method of claim 1, further comprising generating a report for said subject based on said evaluation.

15. The method of claim 1, comprising evaluating a plurality of types of biological samples collected from a subject, wherein said data transmitted from said device comprises raw data from said plurality of types of biological samples, wherein at least one of said biological samples comprises a cell.

16. The method of claim 15, wherein preparing the biological sample and yielding raw data within said housing comprises yielding raw data within said housing from at least two types of biological samples and at least two assays selected from an immunoassay, a nucleic acid assay, a receptor-based assay, and an enzymatic assay.

17. The method of claim 15, wherein the evaluation of said plurality of types of biological samples is effected without transporting any of said samples from the designated sample collection site to the laboratory location.

18. The method of claim 15, wherein fluid samples of the plurality of types of biological samples each have a volume of 250 μ

L or less.

19. The method of claim 15, wherein said oversight includes the selection of analysis methodology and procedures for each of said plurality of types of biological samples.

20. A system of evaluating a biological sample collected from a subject, said system comprising:

(a) a communication unit placed at a laboratory location configured to receive raw data from a device placed at a designated sample collection site separate from said laboratory location, wherein the device comprises a housing and is configured to process a biological sample within said housing, said biological sample comprising a cell, said processing by said device generating raw data for a subsequent qualitative and/or quantitative evaluation of said biological sample, and wherein the device comprises;

(i) a sample collection unit within said housing configured to receive the biological sample;

(ii) a sample preparation unit within said housing configured to prepare the biological sample and to yield raw data from multiplexed assays performed on a single sample for the evaluation within said housing, wherein the sample preparation unit comprises (i) a pipette, and ii) a centrifuge, a thermal controller, and a cytometer, said sample is provided to the device in a cartridge, wherein said raw data (1) comprises numerical values representative of a physical process or chemical reaction performed by the device and (2) and electronic data representative of an image of a cell in said biological sample; and

(iii) a transmission unit configured to transmit the raw data from said designated sample collection site to said laboratory location;

(b) a processor at said laboratory location that processes said data alone or in conjunction with an individual affiliated with the laboratory for (A) the evaluation of said biological sample at the laboratory location, and (B) the oversight of said integrity of evaluation and operation of said device, such that results generated from said evaluation can be utilized by a health care professional for diagnosis or treatment of said subject.

21. The system of claim 20, wherein said sample preparation unit comprises a fluid handling system comprising a pipette within said housing.

22. The system of claim 20, wherein said sample preparation unit comprises a centrifuge within said housing.

23. The system of claim 20, wherein the authorized analytical facility is a Clinical Laboratory Improvement Amendments (CLIA)-compliant laboratory.

24. The system of claim 20, wherein said designated sample collection site is a site selected from the group consisting of a retailer site, the subject'"'"'s home, and a health assessment/treatment location.

25. The system of claim 20, wherein said electronic data representative of an image of a cell in said biological sample comprises electronic data derived from an optical assessment of histology or morphology of said cells, and said raw data comprises raw data from an image of a physical process or chemical reaction performed by the device with said biological sample or a portion thereof.

26. The system of claim 20, wherein said raw data comprises raw data from at least two assays selected from an immunoassay, a nucleic acid assay, a receptor-based assay, and an enzymatic assay.

27. The system of claim 20, wherein the evaluation of said biological sample is effected without transporting said sample from the designated sample collection site laboratory location.

28. The system of claim 20, wherein said processor at said laboratory location is configured to generate a report.

29. The system of claim 20, wherein the processor is configured to communicate with a record database comprising one or more medical records of, or insurance information for, the subject.

30. The system of claim 20, wherein the processor is configured to communicate with a payer database comprising the insurance information for the subject.