Biological status classification

Patent metadata

Field	Value
Publication number	US-12498377-B2
Application number	US-202016943348-A
Country	US
Kind code	B2
Filing date	Jul 30, 2020
Priority date	Aug 2, 2019
Publication date	Dec 16, 2025
Grant date	Dec 16, 2025

Abstract

There is provided a method of classifying a biological status of an individual. The method comprising: obtaining a biological sample from a patient; obtaining health-related information from the patient, said information including patient gender; analysing the sample to identify a quantity of each of 2 or more endogenous analytes in the sample; comparing the analyte quantities to reference data from healthy individuals to classify the patient as healthy, pre-diseased, at risk of disease or diseased for at least one health-related condition. The reference data includes data derived from a group of biological samples of individuals having the same gender as the patient and not having a need for medical treatment for a disease or illness, each biological sample of the group of biological samples having been analysed by the same process as used to analyse the patient sample, the process being monitored to maintain a predetermined level of consistency.

First claim

The invention claimed is:

1 . In a method of treating an individual in which a first biological sample of the individual obtained at a first time and a second biological sample of the individual obtained at a second time are analysed to identify a quantity of each of 2 or more analytes in the first and second samples and the analyte quantities in the first and second samples are compared to a first reference range of first reference data and a second reference range of second reference data, respectively, to classify the individual as healthy, pre-diseased, at risk of disease or diseased for at least one health-related condition, and upon finding the individual is pre-diseased, at risk of disease, or diseased, applying an appropriate medical treatment to the individual, the improvement comprising:
obtaining health-related information from the patient at the first time and at the second time, wherein the health-related information at the first time comprises an indication of a first geographic location and wherein the health-related information at the second time comprises an indication of a second geographic location which is different from the first geographic location, wherein the first geographic location has a first diagnostic unit for analysing the first biological sample obtained at the first time and the second geographic location has a second diagnostic unit for analysing the second biological sample obtained at the second time, wherein the first reference range is a geographically-specific reference range corresponding to the first geographic location, and the first reference data is derived from a first group of biological samples of individuals having the same gender as the individual and not having a need for medical treatment for a disease or illness, each biological sample of the first group of biological samples having been analysed by the same process and using the same first diagnostic unit as used to analyse the first biological sample, wherein each biological sample of the first group of biological samples is a biological sample obtained from individuals at the first geographic location, and wherein the first geographic location is a home region of the individual, wherein the second reference range is a geographically-specific reference range corresponding to the second geographic location, and the second reference data is derived from a second group of biological samples of individuals having the same gender as the individual and not having a need for medical treatment for a disease or illness, each biological sample of the second group of biological samples having been analysed by the same process and using the same second diagnostic unit as used to analyse the second biological sample, and wherein each biological sample of the second group of biological samples is a biological sample obtained from individuals at the second geographic location, and wherein the second geographic location is not a home region of the individual.

2 . The method according to claim 1 , wherein the health-related information includes age, and the individual is in the same age cohort of the individuals of the group of biological samples.

3 . The method according to claim 1 , wherein the analyte quantities in the first and second samples comprise quantities of one or more endogenous analytes selected from the group consisting of Glucose, Albumin, HbAlc, HDL, Sodium, Cholesterol, WBC, Calcium, Creatinine, ALT, Urea, Cystatin C, CRP, AAT, GGT, Total bilirubin, Lipase, TAS, H. pylori , Ferritin, CK Nac, Insulin, FT4, IgG, Magnesium, TSH, Vitamin D, IgE, Myoglobin, Uric acid, ASO, Vitamin B12, Rheumatoid factor, Iron, Transferrin, AST, Folic acid, FT3, Pancreatic amylase, and ALP, and
wherein for endogenous analytes glucose, sodium, cholesterol, WBC, calcium, ALT, cystatin C, CRP, AAT, total bilirubin, lipase, TAS, albumin, HbA1c, HDL, urea, insulin, and magnesium the reference range values assigned to each endogenous analyte corresponds to upper and lower values of the 95% percentile calculated from biological samples of the group of biological samples.

4 . The method according to claim 1 , further comprising:
when the method indicates the individual is pre-diseased, at risk of disease or diseased, analysing a further biological sample obtained from the individual after a predetermined time interval.

5 . The method according to claim 1 , wherein the analyte quantities in the first and second samples comprise one or more exogenous analytes,
wherein classifying the individual as healthy, pre-diseased, at risk of disease or diseased for at least one health-related condition comprises classifying, based upon the presence, absence or a concentration of biochemicals in the sample, the individual as disease free without exogenous contaminant, disease free with exogenous toxic biochemical, pre-disease without exogenous toxic biochemical, pre-disease with exogenous toxic biochemical, disease present without exogenous toxic biochemical or disease present with exogenous toxic biochemical.

6 . The method according to claim 1 , wherein each of the first and second diagnostic units are co-located with a respective fitness unit or nutritional unit.

7 . The method according to claim 1 , wherein each of the first and second diagnostic units comprise one or more analysers for analysing the first and second biological samples, each analyser used for a specific analyte in each respective sample being of the same model analyser, and wherein:
(a) each analyser used for the specific analyte is the same analyser as used for a previous analysis of the specific analyte in a sample from the same individual; (b) each analyser used for the specific analyte is derived from a single manufacturer; or (c) the reagents used during sample analysis are derived from a same single manufacturer.

8 . The method according to claim 1 , wherein when sample analysis is to transition from a first analyser to a further analyser, the same model analyser or a newer model of the analyser is used as the further analyser, and wherein one or more samples from one or more individuals that have been analysed on the first analyser are further analysed on the further analyser.

9 . The method of claim 4 further comprising: obtaining health-related information from the individual again after the predetermined time interval.

10 . The method of claim 5 further comprising: referring to a nutritional and personal care specialist an individual who is classified as disease free with exogenous toxic biochemical or pre-disease with exogenous toxic biochemical.

11 . The method of claim 1 , wherein when the individual is classified as pre-diseased, at risk of disease, or diseased based on the analysis, the individual is put on a healthcare regime provided by a medical professional based on the identified quantity of one or more of the analytes.

Assignees

• Randox Laboratories Ltd

Inventors

• Innocenzi Paul John
• Fitzgerald Stephen Peter
• Mcconnell Ivan Robert

Classifications

• G01N2800/50

  Determining the risk of developing a disease · CPC title

• G16H20/60

  relating to nutrition control, e.g. diets · CPC title

• G16H50/30 Primary

  for calculating health indices; for individual health risk assessment · CPC title

• G16H10/40

  for data related to laboratory analysis, e.g. patient specimen analysis · CPC title

• G16H70/60

  relating to pathologies · CPC title