Integrated health data capture and analysis system

• US 8,862,448 B2
• Filed: 10/18/2010
• Issued: 10/14/2014
• Est. Priority Date: 10/19/2009
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth A., Gibbons, Ian, Young, Daniel L., Michelson, Seth G.
• Primary Examiner(s): Jacob, Mary C
• Application Number:
  US12/906,975
• Publication Number:
  US 20110093249A1
• Time in Patent Office: 1,457 Days
• Field of Search: 703/6
• US Class Current: 703/6
• 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, comprising:

a plurality of point-of-care (POC) devices each comprising at least one programmable processor for executing at least one assay according to at least one assay protocol wherein the assay protocol comprises at least fluid transfer instructions to be performed by the POC devices;

a central computing device operably in data communication with said plurality of POC devices, wherein the POC devices are positioned at distributed locations physically separate from the central computing device;

a static database component comprising static data related to the disease and/or the population;

a dynamic database component comprising dynamic data about the population and individual subjects, wherein the data in the dynamic database component comprises an indication of disease state of individuals in the population; and

a computer modeling component that is configured to generate a model of the progression of the disease within the population based on the data in (1) the static database component and (2) the dynamic database component, thereby providing modeling results;

wherein said at least one assay protocol when changed at the central computing device based at least on said modeling results, is sent from the central computing device to said plurality of POC devices for execution of a changed assay protocol by the devices without having to provide new devices to the distributed locations.

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 the static database component comprises information about the individuals in the population comprising one or more of age, race, sex, location, genetic factors, single nucleotide polymorphisms (SNPs), family history, disease history or therapeutic history.

6. The system of claim 1, wherein the static database component comprises information about the disease, wherein the information about the disease comprises one or more of virulence, contagiousness, mode of transmission, treatment availability, vaccine availability, death rate, recovery time, cost of treatment, infectivity, rate of spread, rate of mutation, and past outbreak.

7. The system of claim 1, wherein the data in the dynamic database component is updated in real-time.

8. The system of claim 1, wherein the biomarker is measured in a sample of bodily fluid from the individual.

9. The system of claim 8, wherein the bodily fluid comprises blood, plasma, serum, sputum, urine, feces, semen, mucous, lymph, saliva, or nasal lavage.

10. The system of claim 1, wherein the point of care device performs one or more of cartridge assays, real time PCR, rapid antigen tests, viral culture, and immunoassays.

11. The system of claim 1, wherein the point of care device 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.

12. 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.

13. The system of claim 12, 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.

14. The system of claim 12, wherein the one or more courses of action comprise a strategy to control the spread of the disease.

15. The system of claim 14, 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.

16. 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 the disease status of an individual or group of individuals using a point of care device.

17. The system of claim 1, wherein the model of the data 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.

18. The system of claim 1 wherein each of the point-of-care devices comprises a robotic pipette controlled by said programmable processor.

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

20. The system of claim 1 wherein said change comprises a revised schedule for performing assays.

21. The system of claim 1 wherein an analyte set comprising one or more analytes is chosen prospectively as a sub-set of analytes from a set comprising two or more analytes to be assayed by an assay, wherein said assay is selected from an assay menu that can be performed by the point-of-care devices.

22. The system of claim 1 wherein the 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.