Integrated health data capture and analysis system

• US 9,460,263 B2
• Filed: 10/10/2014
• Issued: 10/04/2016
• Est. Priority Date: 10/19/2009
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (FIG LLC (d/b/a Fortress Investment Group LLC))
• Original Assignee: Theranos Incorporated
• Inventors: Gibbons, Ian, Holmes, Elizabeth A., Young, Daniel L., Michelson, Seth G.
• Primary Examiner(s): Shah, Kamini S
• Assistant Examiner(s): OCHOA, JUAN CARLOS
• Application Number:
  US14/511,753
• Publication Number:
  US 20150100345A1
• Time in Patent Office: 725 Days
• Field of Search: 703/6, 703/11, 702/19
• US Class Current: 1/1
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16H 50/80 for detecting, monitoring or modelling epidemics or pandemics, e.g. flu
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The present invention provides an integrated health care surveillance and monitoring system that provides real-time sampling, modeling, analysis, and recommended interventions. The system can be used to monitor infectious and chronic diseases. When faced with outbreak of an infectious disease agent, e.g., influenza virus, the system can identify active cases through pro-active sampling in high risk locations, such as schools or crowded commercial areas. The system can notify appropriate entities, e.g., local, regional and national governments, when an event is detected, thereby allowing for proactive management of a possible outbreak. The system also predicts the best response for deployment of scarce resources.

Claims

1. A system for modeling a progression of a disease within a population, the system comprising:

a plurality of point-of-care sample processing devices each comprising a programmable fluid transfer device, at least one optical detector, and a communications assembly;

a central computing device operably in data communication with said plurality of point-of-care sample processing devices through the communications assembly on each of the sample processing devices, wherein the sample processing devices are positioned at distributed locations physically separate from the central computing device;

a computer modeling component configured to generate a model of the progression of the disease within the population based on data received by the central computing device from the sample processing devices and data in (1) a static database component and (2) a dynamic database component and provide modeling results;

wherein said central computing device electronically sends at least one protocol for running an assay based at least on said modeling results, to said plurality of sample processing devices without having to provide new sample processing devices to the distributed locations, wherein the protocol comprises at least one fluid transfer instruction to be performed by the programmable fluid transfer device.

2. The system of claim 1, wherein the disease is an infectious disease or a chronic disease.

3. The system of claim 2, wherein the disease is an infectious disease caused by a microorganism, a microbe, a virus, a bacterium, an archaeum, a protozoan, a protist, a fungus or a microscopic plant.

4. The system of claim 2, wherein the disease is a chronic disease or condition selected from the group consisting of diabetes, prediabetes, insulin resistance, metabolic disorder, obesity, and cardiovascular disease.

5. The system of claim 1, wherein one of the sample processing devices processes sample of bodily fluid from an individual.

6. The system of claim 5, wherein the bodily fluid comprises blood, plasma, serum, sputum, urine, feces, semen, mucous, lymph, saliva, or nasal lavage.

7. The system of claim 1, wherein one of the sample processing devices performs one or more of cartridge assays, real time PCR, rapid antigen tests, viral culture, and immunoassays.

8. The system of claim 1, wherein one of the sample processing devices is positioned at one or more of a school, a workplace, a shopping center, a community center, a religious institution, a hospital, a health clinic, a mobile unit, or a home.

9. The system of claim 1, wherein the computer modeling component is configured to predict one or more courses of action based on the modeling results, wherein the one or more courses of action are ranked according to a ranking parameter.

10. The system of claim 9, wherein the ranking parameter comprises financial considerations, number of affected individuals, quality-adjusted life year (QALY), and/or quality-adjusted life year (QALY) per economic cost unit.

11. The system of claim 9, wherein the one or more courses of action comprise a strategy to control the spread of the disease.

12. The system of claim 11, wherein the strategy to control the spread of the disease comprises one or more of household quarantine, individual quarantine, geographic quarantine, social distancing, hospitalization, school closure, work place closure, travel restrictions, public transit closure, therapeutic treatment or intervention, prophylactic treatment or intervention, vaccination, provision of protective clothing, provision of masks, and additional point-of-care testing.

13. The system of claim 1, wherein the computer modeling component is configured to estimate a surveillance strategy based on the modeling results, and wherein the surveillance strategy comprises determining a disease status of an individual or group of individuals using a point of care device.

14. The system of claim 1, wherein the model comprises a plurality of states, wherein the plurality of states comprise one or more of:

susceptible individuals, early exposed individuals, late exposed individuals, early infected individuals, late infected individuals, recovered individuals, individuals who died due to the infection and/or associated complications, asymptomatic individuals, individuals given therapeutic treatment, individuals given therapeutic treatment and quarantined, individuals treated prophylactically, vaccinated individuals, individuals protected due to vaccination, early infected individuals who are hospitalized, late infected individuals who are hospitalized, susceptible individuals who are home quarantined, early exposed individuals who are home quarantined, late exposed individuals who are home quarantined, early infected individuals who are home quarantined, late infected individuals who are home quarantined, asymptomatic individuals who are home quarantined, susceptible individuals quarantined in the whole neighborhood, early exposed individuals quarantined in the whole neighborhood, late exposed individuals quarantined in the whole neighborhood, early infected individuals quarantined in the whole neighborhood, late infected individuals quarantined in the whole neighborhood, asymptomatic individuals quarantined in the whole neighborhood, amount of therapeutic drug doses available, amount of antivirals and/or antibiotics available to the target population, home quarantined individuals that are vaccinated, home quarantined individuals that are protected due to vaccination, home quarantined individuals that recovered, susceptible individuals earmarked by mitigation policies for action, early exposed individuals earmarked by mitigation policies for action, late exposed individuals earmarked by mitigation policies for action, asymptomatic individuals earmarked by mitigation policies for action, early infected individuals earmarked by mitigation policies for action, late infected individuals earmarked by mitigation policies for action, prophylactic-treated individuals earmarked by mitigation policies for action, vaccinated individuals earmarked by mitigation policies for action, protected individuals earmarked by mitigation policies for action, recovered individuals earmarked by mitigation policies for action, susceptible individuals earmarked for therapeutic treatment, early exposed individuals earmarked for therapeutic treatment, late exposed individuals earmarked for therapeutic treatment, asymptomatic individuals earmarked for therapeutic treatment, early infected individuals earmarked for therapeutic treatment, late infected individuals earmarked for therapeutic treatment, susceptible individuals earmarked for surveillance, early exposed individuals earmarked for surveillance, late exposed individuals earmarked for surveillance, asymptomatic individuals earmarked for surveillance, early infected individuals earmarked for surveillance, late infected individuals earmarked for surveillance, prophylactic individuals earmarked for surveillance, vaccinated individuals earmarked for surveillance, protected individuals earmarked for surveillance, susceptible individuals in whole neighborhood quarantine earmarked by mitigation policies for action, early exposed individuals in whole neighborhood quarantine earmarked by mitigation policies for action, late exposed individuals in whole neighborhood quarantine earmarked by mitigation policies for action, asymptomatic individuals in whole neighborhood quarantine earmarked by mitigation policies for action, early infected individuals in whole neighborhood quarantine earmarked by mitigation policies for action, late infected individuals in whole neighborhood quarantine earmarked by mitigation policies for action, prophylactic-treated individuals in whole neighborhood quarantine individuals earmarked by mitigation policies for action, cumulative number of therapeutic doses administered, cumulative number of antivirals and/or antibiotics administered, cumulative number of home quarantined asymptomatic individuals, cumulative number of home quarantined symptomatic individuals, cumulative number of total infected individuals, cumulative number of infected individuals who are not quarantined, cumulative number of infected individuals with some action taken, cumulative number of hospitalized individuals, and cumulative number of deaths.

15. The system of claim 1 wherein said programmable fluid transfer device comprises a robotic pipette controlled by a programmable processor.

16. The system of claim 1 wherein the central computing device stores a plurality of protocols for a group of individuals.

17. The system of claim 1 wherein one of the sample processing devices is configured to receive a cartridge comprising the sample and a plurality of reagent units and assay units.

18. The system of claim 1 wherein the computer modeling component selects a first set of assays for testing and based on testing results, selects a second set of assays to test on selected individuals, wherein assays of said second set of assays are more sensitive than corresponding assays of said first set.

19. The system of claim 1, wherein one of the sample processing devices comprises a portable instrument.

20. The system of claim 1, wherein one of the sample processing devices comprises a benchtop instrument.