Obstructive sleep apnea (osa) biomarker panel
AssigneeBeckman Coulter, Inc.
InventorsPaula C. Southwick, Jiuliu Lu, John S. Riley, Michael K. Samoszuk, Amabelle B. Cruz
Life of this patent
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Abstract
This invention provides combinations of biomarkers for diagnosis of obstructive sleep apnea.
Claims27
A method of diagnosing obstructive sleep apnea (OSA) in a patient, the method comprising
- a. measuring the levels of two or more biomarkers in a sample from a patient, the biomarkers selected from the group consisting of HbA1c, CRP, IL-6, uric acid, and EPO;
- b. determining a multimarker index for the two or more biomarkers using a predetermined algorithm;
- c. comparing the multimarker index with a predetermined reference value for the multimarker index;
- and
- d. diagnosing the patient as having OSA if the multimarker index is higher than the predetermined reference value and the predetermine algorithm is positive logic;
- or
- diagnosing the patient as having OSA if the multimarker index is lower than the predetermined reference value and the predetermined algorithm is negative logic
- wherein the biomarkers are selected such that the AUC of the method of using the combined biomarkers in diagnosing OSA is at least 0.8.
(canceled)
A method of determining whether a therapy is effective for treating OSA, comprising the steps of
- a) taking a sample from a patient before the therapy;
- b) measuring the levels of two or more biomarkers in the sample from the patient, wherein the two or more biomarkers are selected from the group of HbA1c, CRP, IL-6, uric acid, and EPO;
- c) determining a pre-treatment multimarker index for the two or more biomarkers using a predetermined algorithm;
- d) taking a sample from the patient at a time point after the therapy;
- e) measuring the levels of the two or more biomarkers that are selected from the group of HbA1c, CRP, IL-6, uric acid, and EPO;
- f) determining a post-treatment multimarker index for the two or more biomarkers using the predetermined algorithm;
- and
- g) determining the therapy is effective if the post-treatment multimarker index is lower than the pre-treatment multimarker index and the predetermined algorithm is positive logic;
- or determining the therapy is effective if the multimarker index is higher than the predetermined reference value and the predetermined algorithm is negative logic.
A method of determining whether a therapy is effective for treating OSA, comprising the steps of
- a) taking a sample from a patient at a time point during or after the therapy;
- b) measuring the levels of two or more biomarkers that are selected from the groups consisting of HbA1c, CRP, IL-6, uric acid, and EPO;
- c) determining a post-treatment multimarker index for the two or more biomarkers using a predetermined algorithm;
- and
- d) determining the therapy is effective if the post-treatment multimarker index is lower than a predetermined reference value for the multimarker index for the two or more biomarkers and the predetermined algorithm is positive logic;
- or determining the therapy is effective if the multimarker index is higher than the predetermined reference value and the predetermined algorithm is negative logic.
-19. (canceled)
A non-transitory computer readable medium having computer-executable instructions which, when executed, causes a processor to:
- a) access data attributed to a sample from a patient, the data comprising measurement of two or more biomarkers selected from the group consisting of HbA1c, CRP, IL-6, uric acid, and EPO;
- and
- b) execute a predetermined algorithm to produce a multimarker index of the two or more biomarkers;
- wherein the patient is diagnosed as having OSA if the multimarker index is higher than a predetermined reference value for that multimarker index and the predetermined algorithm is positive logic;
- or the patient is diagnosed as having OSA if the multimarker index is lower than the predetermined reference value and the predetermined algorithm is negative logic;
- wherein the predetermined algorithm is a combination of biomarkers, wherein the combination is Linear Model—Linear Value, Linear Model—Log Value, Non-linear Model—Linear Value, or Non-linear Model—Log Value combination;
- and
- wherein the biomarkers are selected such that the AUC of the method of using the combination of the two or more biomarkers in diagnosing OSA is at least 0.8.
24-26. (canceled)
A computer implemented method for diagnosing obstructive sleep apnea in a patient comprising:
- a) measuring the levels of two or more biomarkers in a sample from a patient, the biomarkers selected from the group consisting of HbA1c, CRP, IL-6, uric acid, and EPO;
- b) determining a multimarker index for the two or more biomarkers using a predetermined algorithm with one or more computer processors;
- c) comparing the multimarker index with a predetermined reference value for the multimarker index;
- and
- d) diagnosing the patient as having OSA if the multimarker index is higher than the predetermined reference value and the predetermined algorithm is positive logic;
- or
- diagnosing the patient as having OSA if the multimarker index is lower than the predetermined reference value and the predetermined algorithm is negative logic.
A method of predicting or diagnosing obstructive sleep apnea (OSA) in a subject, the method comprising:
- a. measuring the level of HbA1c and at least one biomarker selected from CRP, IL-6, uric acid and erythropoietin (EPO) in a sample from the subject
- b. predicting or diagnosing OSA in the subject if the measured level of the biomarkers selected in a) are elevated.
Dependencies are inferred from the claim text.