IP Library Granted Patent US 11,302,431
Granted Patent B2
US 11,302,431 · App. 16/264,397 · Granted Apr 12, 2022

Systems and methods for quantification and presentation of medical risk arising from unknown factors

Inventors: Howard C. Coleman (Seattle, WA); Robert D. Patterson (Lexington, MA); Jessica Oesterheld (Bath, ME); Rajeev V. Pany (Issaquah, WA); Kristine Ashcraft (Burien, WA)
Assignee: Invitae Corporation
G16H20/13G16C20/30G16H20/10G16H50/30G16H70/40
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Quick Facts
Patent No.
US 11,302,431
App. No.
16/264,397
Granted
Apr 12, 2022
Kind
B2
Abstract

Example methods of quantifying known and unknown risks of an adverse drug event in an individual based on various factors are disclosed. In some embodiments, factors include known drug-drug interactions and unknown phenotypes of cytochromes. Quantification may be based on severity of the adverse drug event/and or probability of occurrence in some embodiments. Example methods of displaying the quantified risk are also disclosed. In one embodiment, the risk of individuals is aggregated to display the risk of a population.

Claims (53)

1. A method comprising:

receiving, by a processor, identification of at least one drug;

selecting, using the computing system, certain factors affecting exposure of an individual to the at least one drug, wherein the certain factors include a genotype and one or more of hospital incident data, adverse event data, medical coding data, or combinations thereof;

quantifying, by the processor, an expected effect on metabolism of the at least one drug by the individual due to the certain factors by;

identifying, by the processor, one or more possible values of at least one certain factor; and

weighting, by the processor, the expected effect using each of the one or more possible values based on a matrix of probabilities of phenotypes;

generating, by the processor, a numerical representation of risk based at least in part on the expected effect by weighting a severity of the expected effect;

displaying, by the processor, the numerical representation of risk in an interaction report;

pooling, by the processor, a respective numerical representation of risk associated with the at least one drug for each patient of a patient population, wherein the patient population includes the individual;

determining, by the processor, that one or more patients in the patient population are recommended for genetic testing based on the respective numerical representation of the risk for each of the one or more patients; and

displaying, by the processor, a genetic testing recommendation chart indicating a portion of the patient population, the portion of the patient population comprising the one or more patients in the patient population recommended for genetic testing.

2. The method of claim 1 , wherein the certain factors further comprise a patient phenotype, liver function, kidney function, gender, weight, age, ethnicity, or combinations thereof.

3. The method of claim 1 , wherein quantifying the expected effect on metabolism of the at least one drug comprises identifying a metabolic route used to metabolize the at least one drug.

4. The method of claim 1 , further comprising generating by the processor, a second numerical representation of risk based at least in part on prospective genetic testing for the individual to determine the genotype.

5. The method of claim 1 , further comprising displaying, by the processor, a graphical indicator that genetic testing is recommended.

6. The method of claim 1 , further comprising:

displaying, by the processor, aggregate risk data representative of the patient population in the genetic testing recommendation chart, wherein the aggregate risk data is segmented based on a severity of risk of an adverse drug event occurring; and

displaying, by the processor, a change in unmanaged interaction risk over time, wherein the unmanaged interaction risk is associated with the numerical representation of risk and comprises a known risk that has not been acted upon by the individual or a medical care provider, an unknown risk that has not been acted upon by the individual or the medical care provider, or both the known risk and unknown risk.

7. The method of claim 1 , wherein quantifying the expected effect on metabolism of the at least one drug comprises compiling a matrix of expected effects by evaluating a plurality of interactions between the at least one drug and the certain factors.

8. A non-transitory computer readable medium encoded with executable instructions thereon that, when executed by at least one computing device, cause the at least one computing device to perform operations comprising:

receiving identification of at least one drug;

selecting certain factors affecting exposure of an individual to the at least one drug;

quantifying an expected effect on metabolism of the at least one drug by the individual due to the certain factors by;

identifying one or more possible values of at least one certain factor; and

weighting the expected effect using each of the one or more possible values based on a matrix of probabilities of phenotypes;

generating a numerical representation of risk based at least in part on the expected effect by weighting a severity of the expected effect;

displaying the numerical representation of risk in an interaction report;

pooling a respective numerical representation of risk associated with the at least one drug for each patient of a patient population, wherein the patient population includes the individual;

determining that one or more patients in the patient population are recommended for genetic testing based on the respective numerical representation of risk for each of the one or more patients; and

displaying a genetic testing recommendation chart indicating a portion of the patient population, the portion of the patient population comprising the one or more patients in the patient population recommended for genetic testing.

9. The non-transitory computer readable medium of claim 8 , wherein the operations further comprise displaying aggregate risk data representative of the patient population.

10. The non-transitory computer readable medium of claim 9 , wherein the operations further comprise displaying the aggregated risk data in an unmanaged interaction risk chart segmented based on a severity of risk of an adverse drug event occurring, wherein unmanaged interaction risk is associated with the numerical representation of the risk and comprises a known risk, an unknown risk, or both that has not been acted upon by an individual or a medical care provider.

11. The non-transitory computer readable medium of claim 9 , wherein the operations further comprise displaying the aggregated risk data in the genetic testing recommendation chart.

12. The non-transitory computer readable medium of claim 10 , wherein the operations further comprise determining a change in the unmanaged interaction risk over time.

13. The non-transitory computer readable medium of claim 8 , wherein the certain factors include a drug metabolizing enzyme, a glucuronosyltransferase enzyme, or a transporter protein.

14. A system comprising:

a memory comprising instructions stored thereon; and

a processor coupled to the memory, wherein the instructions, when executed by the processor, cause the processor to:

quantify an expected effect of a drug on an individual due to certain factors by:

identifying one or more possible values of at least one of the certain factors; and

weighting the expected effect using each of the one or more possible values based on a matrix of probabilities of phenotypes;

generate a numerical representation of risk based at least in part on the expected effect by weighting a severity of the expected effect;

determine an unmanaged interaction risk associated with the drug for a patient population, the patient population including the patient, based on the numerical representation of the risk;

pool the unmanaged interaction risk for the patient population;

determine that one or more patients in the patient population are recommended for genetic testing based on a value of the unmanaged interaction risk for each of the one or more patients being more than a predetermined threshold;

display an unmanaged interaction risk chart segmented based on a severity of risk of an adverse drug event occurring; and

display a genetic testing recommendation chart including one or more segments, wherein at least one segment indicates a portion of the patient population, the portion of the patient population comprising the one or more patients in the patient population recommended for genetic testing.

15. The system of claim 14 , wherein the instructions further cause the processor to display a risk-reduction effect of missing genetic data in response to a user toggling the unmanaged interaction risk chart or the genetic testing recommendation chart, wherein the risk-reduction effect is based on performing genetic testing, modification to a treatment, or change in medication.

16. The system of claim 14 , wherein the instructions further cause the processor to display one or more visual indicators on the unmanaged interaction risk chart indicating a severity of the adverse drug event.

17. The system of claim 14 , wherein the instructions further cause the processor to display one or more visual indicators on the genetic testing recommendation chart indicating whether genetic testing is recommend.

18. The system of claim 14 , wherein the instructions further cause the processor to display a text representation of the unmanaged interaction risk chart and/or the genetic testing recommendation chart.

19. The system of claim 14 , wherein the numerical representation of the risk corresponds due to drug-drug interaction or drug-gene interaction.

20. The system of claim 14 , wherein unmanaged interaction risk is associated with the numerical representation of risk and comprises a known risk that has not been acted upon by a patient of the plurality of patients or a medical care provider, an unknown risk that has not been acted upon by the patient of the plurality of patients or the medical care provider, or both the known risk and unknown risk.

Assignments (8)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 21, 2023
From: YOUSCRIPT, LLC; INVITAE CORPORATION
To: YOUSCRIPT TECHNOLOGIES, LLC
Reel/Frame 065633/0272 →
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2023
From: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION, IN ITS CAPACITY AS COLLATERAL AGENT FOR THE SECURED PARTIES
To: INVITAE CORPORATION
Reel/Frame 065620/0119 →
SECURITY INTEREST Recorded Mar 13, 2023
From: INVITAE CORPORATION
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 063787/0148 →
RELEASE OF SECURITY INTEREST Recorded Mar 6, 2023
From: PERCEPTIVE CREDIT HOLDINGS III, LP
To: INVITAE CORPORATION; GOOD START GENETICS, INC.; SINGULAR BIO, INC.; YOUSCRIPT, LLC
Reel/Frame 063282/0538 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 11, 2021
From: YOUSCRIPT, LLC
To: INVITAE CORPORATION
Reel/Frame 056201/0796 →
PATENT SECURITY AGREEMENT Recorded Oct 2, 2020
From: INVITAE CORPORATION; GOOD START GENETICS, INC.; SINGULAR BIO, INC.; YOUSCRIPT, LLC
To: PERCEPTIVE CREDIT HOLDINGS III, LP
Reel/Frame 054234/0872 →
MERGER AND CHANGE OF NAME Recorded Apr 16, 2020
From: YOUSCRIPT INCORPORATED; YASAWA MERGER SUB B LLC
To: YOUSCRIPT, LLC
Reel/Frame 052423/0439 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2019
From: COLEMAN, HOWARD C.; PATTERSON, ROBERT D.; OESTERHELD, JESSICA; PANY, RAJEEV V.; ASHCRAFT, KRISTINE
To: YOUSCRIPT INC.
Reel/Frame 048214/0123 →