SYSTEMS AND METHODS FOR SAMPLE PROCESSING AND ANALYSIS

• US 20130080071A1
• Filed: 09/26/2011
• Published: 03/28/2013
• Est. Priority Date: 09/25/2011
• Status: Abandoned Application

• Current Assignee: Theranos Incorporated
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth
• Application Number:
  US13/244,951
• Publication Number:
  US 20130080071A1
• Time in Patent Office: Days
• US Class Current: 702/21
• CPC Class Codes: G16B 50/00 ICT programming tools or database systems specially adapted for bioinformatics
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

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 at a designated site, said method comprising:

(a) collecting and processing, by a Clinical Laboratory Improvement Amendments (CLIA)-compliant device the biological sample at said designated site wherein the sample is collected from the subject, and wherein the device is configured to

(i) receive the biological sample;

(ii) prepare the biological sample and yield data for a subsequent qualitative and/or quantitative evaluation of said biological sample; and

(iii) transmit the data to a health care provider of an authorized analytical facility and/or an affiliate thereof for performance of said evaluation; and

(b) transmitting the data to the authorized analytical facility and/or an affiliate thereof;

where said evaluation is carried out, wherein said evaluation utilizes the data transmitted from the device and yields results that can be utilized by a health care professional for the diagnosis or treatment of said subject, and wherein the authorized analytical facility and the designated site are distinct facilities.

2. The method of claim 1, wherein the evaluation determines presence or concentration of analyte present in the biological sample or a disease condition of the biological sample.

2-30. -30. (canceled)

3. The method of claim 2, wherein the analyte is selected from the group consisting of protein, nucleic acid, drug, drug metabolite, gas, ions, particles, small molecules and metabolites thereof, elements, toxins, lipids, carbohydrates, prions, formed elements, and combination thereof.

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

5. The method of claim 4, wherein the designated site is the subject'"'"'s home.

6. The method of claim 1, further comprising aggregating the data to a yield a longitudinal analysis over time.

7. The method of claim 1, further comprising generating a report for said subject including information about said evaluation of the biological sample.

8. The method of claim 1, wherein the biological sample is collected from a fingerstick.

9. The method of claim 1, wherein the biological sample has a volume of 250 uL or less.

10. The method of claim 1, further comprising the step of providing oversight (i) by a health care professional of the authorized analytical facility or its affiliate, and/or (ii) by a software program.

11. The method of claim 1 further comprising

(c) verifying (x) whether the subject received an order from a health care professional to undertake said evaluation of said biological sample, or (y) whether the order for the evaluation of said biological sample is within the policy guidelines, restrictions, and/or clinical decision support of a payer or a prescribing physician for said evaluation, and/or (z) whether the subject is covered by health insurance for said evaluation of the biological sample;

wherein said verifying step is performed prior to, concurrently with, or after steps (a) and/or (b).

12. The method of claim 1 further comprising providing the device to the designated site from the authorized analytical facility.

13. The method of claim 1 wherein said evaluation is performed with aid of a processor.

14. The method of claim 1, wherein preparing the biological sample includes performing a biochemical assay.

15. The method of claim 14, wherein the assay is selected from one or more of the following:

immunoassay., enzymatic assay, microscopy, or nucleic acid assay.

16. The method of claim 10, wherein said oversight includes the selection of the evaluation methodology and procedures.

17. The method of claim 10, wherein said oversight is provided by a software program executed by a processor.

18. The method of claim 17, wherein the software program accesses an increasing pool of data and evolving rules and/or procedures.

19. The method of claim 17, wherein the software program is provided on-board the device.

20. The method of claim 17, wherein the software program is provided at the authorized analytical facility and/or affiliate thereof.

21. The method of claim 1, wherein the data is electronic data representative of an image of said biological sample, a physical process and/or chemical reaction performed with said biological sample or a portion thereof.

22. The method of claim 21, wherein the evaluation is performed with the aid of a pathologist of the authorized analytical facility and/or affiliate thereof.