Data based cancer research and treatment systems and methods

Patent metadata

Field	Value
Publication number	US-12112839-B2
Application number	US-202318188443-A
Country	US
Kind code	B2
Filing date	Mar 22, 2023
Priority date	Sep 19, 2019
Publication date	Oct 8, 2024
Grant date	Oct 8, 2024

Abstract

A method and system comprising storing a set of user application programs each requiring an application specific subset of data to perform application processes and generate a respective genomic variant characterization for each of a plurality of patients with cancerous cells and receiving cancer treatment. The method including, obtaining clinical records data including cancer related information, generating genomic sequencing data for the patient's cancerous cells and normal cells, shaping at least a subset of the genomic sequencing data to generate system structured data. Storing the system structured data in a first database, selecting the application specific data from the first database, storing the application specific data in a second database for application program interfacing, receiving the respective genomic variant characterization from the user application program, and storing the genomic variant characterization from the user application program in a third database.

First claim

The invention claimed is:

1. A method for conducting genomic sequencing, the method comprising the steps of:
storing a set of user application programs wherein each of the programs requires an application specific subset of data to perform application processes and generates a respective genomic variant characterization; and
for each of a plurality of subjects that have cancerous cells and that receive cancer treatment:
a. obtaining clinical records data in original forms where the clinical records data includes cancer state information, treatment types and treatment efficacy information;
b. for each subject, using a next generation genomic sequencer to generate genomic sequencing data for the subject's cancerous cells and normal cells;
c. shaping at least a subset of the genomic sequencing data to generate system structured data;
d. storing the system structured data in a first database; and
e. for each user application program;
i. selecting the application specific subset of data from the first database;
ii. storing the application specific subset of data in a structure optimized for application program interfacing in a second database; and
iii. receiving the respective genomic variant characterization from the user application program for each subject of the respective plurality of subjects; and
iv. storing the respective genomic variant characterization received from the user application program for each subject of the respective plurality of subjects in a third database.

2. The method of claim 1 , wherein generating a respective genomic variant characterization comprises a model and training the model comprises fine tuning to improve the performance of the model, wherein the model is a machine learning algorithm or neural network.

3. The method of claim 1 further including the step of storing a plurality of micro-service programs where each micro-service program includes a data consume definition, a data product to generate definition and a data shaping process that converts consumed data to a data product, the step of shaping including running a sequence of micro-service programs to retrieve data, shape the retrieved data into data products and publish the data products back to the first database as structured data.

4. The method of claim 1 , wherein the sequencing is conducted using a plurality of genes from a cell free DNA targeted panel.

5. The method of claim 1 , wherein a first user application program of the set of user application programs comprises prediction of a subject having a genomic variant characterization based at least in part on a presence of a biomarker.

6. The method of claim 5 , wherein the biomarker is selected from one or more of genomic alteration, microsatellite instability, and tumor-mutational burden.

7. The method of claim 1 , wherein a second user application program of the set of user application programs comprises prediction of a subject being at a high-risk of a metastasis to an organ.

8. The method of claim 1 , wherein a third user application program of the set of user application programs comprises prediction of a subject being qualified for a clinical trial or treatment.

9. The method of claim 1 , wherein a fourth user application program of the set of user application programs comprises prediction of a subject having the genomic variant characterization within a time period.

10. The method of claim 1 , wherein a fifth user application program of the set of user application programs comprises prediction of a subject having an oncological event, and wherein the oncological event comprises one or more of:
a diagnosis of an oncological disease state;
a response to a therapy;
a suitability for a therapy;
a suitability for a clinical trial;
a progression free survival;
a progression of cancer;
a metastasis of cancer; and
an origin of a metastasized tumor.

11. The method of claim 1 wherein each cancer state includes a plurality of factors, the method further including the steps of using a processor to automatically perform the steps of analyzing subject genomic sequencing data that is associated with subjects having at least a common subset of cancer state factors to identify treatments of genomically similar subjects that experience treatment efficacies above a threshold level.

12. The method of claim 1 wherein each cancer state includes a plurality of factors, the method further including the steps of using a processor to automatically identify, for specific cancer types, highly efficacious cancer treatments and, for each highly efficacious cancer treatment, identify at least one genomic sequencing data subset that is different for subjects that experienced treatment efficacy above a first threshold level when compared to subjects that experienced treatment efficacy below a second threshold level.

13. The method of claim 1 wherein the sequencing is performed on a particular cancer type.

14. The method of claim 1 , further comprising providing the respective genomic variant characterization stored in the third database as one or more of:
an electronic message;
an alert within an electronic health record system; or
a status report.

15. The method of claim 1 , further including the step of providing identification of an immunotherapy associated with clinical response based on the provided genomic variant characterization, wherein the identification of an immunotherapy is one of CAR-T therapy, antibody therapy, cytokine therapy, adoptive t-cell therapy, anti-CD47 therapy, anti-GD2 therapy, immune checkpoint inhibitor and neoantigen therapy.

16. The method of claim 1 , wherein generating a respective genomic variant characterization comprises detecting a fusion event.

17. The method of claim 1 , wherein the cancer cells are from a tumor tissue and the normal cells from a blood specimen.

18. The method of claim 1 , wherein the genomic sequencing data generated from the subject's cancerous cells are generated from cell free DNA of the cancerous cells.

19. A system for conducting genomic sequencing, comprising:
a computer including a processing device, the processing device configured to:
store a set of user application programs wherein each of the programs requires an application specific subset of data to perform application processes and generates a respective genomic variant characterization; and
for each of a plurality of subjects that have cancerous cells and that receive cancer treatment:
a. obtain clinical records data in original forms where the clinical records data includes cancer state information, treatment types and treatment efficacy information;
b. for each subject, use a next generation genomic sequencer to generate genomic sequencing data for the subject's cancerous cells and normal cells;
c. shape at least a subset of the genomic sequencing data to generate system structured data;
d. store the system structured data in a first database; and
e. for each user application program;
i. select the application specific subset of data from the first database;
ii. store the application specific subset of data in a structure optimized for application program interfacing in a second database;
iii. receive the respective genomic variant characterization from the user application program for each subject of the respective plurality of subjects; and
iv. store the respective genomic variant characterization received from the user application program for each subject of the respective plurality of subjects in a third database.

20. A n

Assignees

• Tempus Ai Inc

Inventors

• Colley Christopher Shane
• Simpson Isaiah
• Reuter Brian
• Tell Robert
• Lefkofsky Hailey
• Lane Hunter
• White Kevin
• Beaubier Nike
• Bush Stephen
• Khan Aly
• Lau Denise
• Shah Kaanan
• Lefkofsky Eric

Classifications

• G16B30/00

  ICT specially adapted for sequence analysis involving nucleotides or amino acids · CPC title

• G16B40/20

  Supervised data analysis · CPC title

• G16H20/10

  relating to drugs or medications, e.g. for ensuring correct administration to patients · CPC title

• G16H50/20

  for computer-aided diagnosis, e.g. based on medical expert systems · CPC title

• G16H50/50

  for simulation or modelling of medical disorders · CPC title