IP Library Granted Patent US 12,299,881
Granted Patent B2
US 12,299,881 · App. 17/934,062 · Granted May 13, 2025

Systems and methods for processing electronic images for biomarker localization

Inventors: Belma Dogdas (Ridgewood, NJ); Christopher Kanan (Pittsford, NY); Thomas Fuchs (New York, NY); Leo Grady (Darien, CT)
Assignee: Paige.AI, Inc.
G06T7/0012G16H10/40G06T2207/20081G06T2207/20084G06T2207/30024G06T2207/30096G16H30/40G16H50/20
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Quick Facts
Patent No.
US 12,299,881
App. No.
17/934,062
Granted
May 13, 2025
Kind
B2
Abstract

Systems and methods are disclosed for receiving digital images of a pathology specimen from a patient, the pathology specimen comprising tumor tissue, the one or more digital images being associated with data about a plurality of biomarkers in the tumor tissue and data about a surrounding invasive margin around the tumor tissue; identifying the tumor tissue and the surrounding invasive margin region to be analyzed for each of the one or more digital images; generating, using a machine learning model on the one or more digital images, at least one inference of a presence of the plurality of biomarkers in the tumor tissue and the surrounding invasive margin region; determining a spatial relationship of each of the plurality of biomarkers identified in the tumor tissue and the surrounding invasive margin region to themselves and to other cell types; and determining a prediction for a treatment outcome and/or at least one treatment recommendation for the patient.

Claims (49)

1. A computer-implemented method, comprising:

receiving one or more digital images of a pathology specimen from a patient, the one or more digital images comprising data about a plurality of biomarkers, a tumor, and a surrounding invasive margin region;

generating, using a machine learning model on the one or more digital images, at least one inference of a presence of the plurality of biomarkers in the tumor and the surrounding invasive margin region, wherein the machine learning model is configured to compare the plurality of biomarkers and determine a spatial relationship, the spatial relationship being determined across at least a portion of the tumor and the surrounding invasive margin region using at least one spatially structured input received from a localized biomarker prediction module; and

predicting a treatment outcome, at least one resistance prediction, and/or at least one treatment recommendation for the patient.

2. The computer-implemented method of claim 1 , wherein generating the at least one inference of the presence of the plurality of biomarkers comprises receiving metadata corresponding to the at least one spatially structured input.

3. The computer-implemented method of claim 1 , wherein the at least one spatially structured input from the localized biomarker prediction module comprises a plurality of vector embeddings.

4. The computer-implemented method of claim 1 , wherein the at least one spatially structured input comprises a spatial structure location comprising information about whether locations of the plurality of biomarker lie in a tumor and/or the surrounding invasive margin region.

5. The computer-implemented method of claim 4 , further comprising:

receiving one or more training digital images associated with a training pathology specimen and an associated indication of an absence of a tumor region; and

dividing the one or more training digital images into at least one sub-region to determine if a tumor tissue is absent in the at least one sub-region.

6. The computer-implemented method of claim 1 , further comprising identifying tumor tissue and the surrounding invasive margin region for each of the one or more digital images by the machine learning model.

7. The computer-implemented method of claim 6 , further comprising:

receiving one or more training digital images associated with a training pathology specimen and an associated indication of a presence of a tumor region; and

dividing the one or more training digital images into at least one sub-region to determine if the tumor tissue is present in the at least one sub-region.

8. The computer-implemented method of claim 6 , further comprising:

receiving one or more digital images associated with a target pathology specimen and an associated indication of a presence of a tumor region;

dividing the one or more digital images into at least one sub-region to analyze to determine if the tumor tissue is present in the at least one sub-region;

applying the machine learning model to one of the one or more digital images to predict which regions of each digital image of the one or more digital images show a tumor tissue; and

indicating and flagging a location of at least one tumor region.

9. The computer-implemented method of claim 1 , wherein generating the at least one inference of the presence of the plurality of biomarkers further comprises:

receiving one or more training digital images of the pathology specimen;

receiving a plurality of data on a level of the plurality of biomarkers present in a tumor and/or an invasive margin region shown in one of the one or more training digital images;

dividing one of the one or more training digital images into at least one sub-region to determine at least one property for the at least one sub-region; and

identifying at least one tumor and/or at least one invasive margin region relevant to a biomarker of interest.

10. The computer-implemented method of claim 1 , wherein generating the at least one inference comprises determining at least one region of interest in a tumor tissue, and applying the machine learning model to determine a prediction of a biomarker expression level in the at least one region of interest.

11. The computer-implemented method of claim 1 , wherein predicting the treatment outcome includes applying the machine learning model to predict the treatment outcome from the localized biomarker.

12. A system, comprising:

at least one memory storing instructions; and

at least one processor configured to execute the instructions to perform operations comprising:

receiving one or more digital images of a pathology specimen from a patient, the one or more digital images comprising data about a plurality of biomarkers, a tumor, and a surrounding invasive margin region;

generating, using a machine learning model on the one or more digital images, at least one inference of a presence of the plurality of biomarkers in the tumor and the surrounding invasive margin region, wherein the machine learning model is configured to compare the plurality of biomarkers and determine a spatial relationship, the spatial relationship being determined across at least a portion of the tumor and the surrounding invasive margin region using at least one spatially structured input received from a localized biomarker prediction module; and

predicting a treatment outcome, at least one resistance prediction, and/or at least one treatment recommendation for the patient.

13. The system of claim 12 , wherein the pathology specimen comprises a cytology specimen.

14. The system of claim 12 , wherein the at least one spatially structured input comprises a spatial structure location comprising information about whether locations of the plurality of biomarker lie in a tumor and/or the surrounding invasive margin region.

15. The system of claim 12 , wherein the data associated with the plurality of biomarkers is identified from at least one of genetic testing, flow cytometry, and immunohistochemistry.

16. The system of claim 12 , wherein the operations further comprise identifying a tumor tissue and the surrounding invasive margin region using the machine learning model by:

receiving one or more training digital images associated with a training pathology specimen and an associated indication of a presence or an absence of a tumor region; and

dividing the one or more training digital images into at least one sub-region to determine if the tumor tissue is present in the at least one sub-region.

17. The system of claim 16 , wherein the operations further comprise applying the machine learning model to one of the one or more digital images to predict which regions show a tumor tissue or an invasive margin.

18. The system of claim 17 , wherein the operations further comprise indicating and flagging a location of at least one tumor region.

19. The system of claim 12 , wherein generating the at least one inference of the presence of the one or more biomarkers further comprises:

receiving one or more training digital images of the pathology specimen;

receiving a plurality of data on a level of the plurality of biomarkers present in a tumor and/or an invasive margin region shown in one of the one or more training digital images;

dividing one of the one or more training digital images into at least one sub-region to determine at least one property for the at least one sub-region; and

identifying at least one tumor and/or at least one invasive margin region relevant to a biomarker of interest.

20. A non-transitory computer readable medium storing instructions that, when executed by a processor, cause the processor to perform a method, the method comprising:

receiving one or more digital images of a pathology specimen from a patient, the one or more digital images comprising data about a plurality of biomarkers, a tumor, and a surrounding invasive margin region;

generating, using a machine learning model on the one or more digital images, at least one inference of a presence of the plurality of biomarkers in the tumor and the surrounding invasive margin region, wherein the machine learning model is configured to compare the plurality of biomarkers and determine a spatial relationship, the spatial relationship being determined across at least a portion of the tumor and the surrounding invasive margin region using at least one spatially structured input received from a localized biomarker prediction module; and

predicting a treatment outcome, at least one resistance prediction, and/or at least one treatment recommendation for the patient.

Assignments (3)
RELEASE OF SECURITY INTEREST Recorded May 14, 2026
From: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
To: PAIGE.AI, INC.
Reel/Frame 075589/0752 →
SECURITY INTEREST Recorded Oct 21, 2025
From: PAIGE.AI, INC.
To: ARES CAPITAL CORPORATION, AS COLLATERAL AGENT
Reel/Frame 073216/0876 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2022
From: DOGDAS, BELMA; KANAN, CHRISTOPHER; FUCHS, THOMAS; GRADY, LEO
To: PAIGE.AI, INC.
Reel/Frame 061190/0156 →
Continuity (4)
Continuation 17519106 · Nov 4, 2021
Continuation 17160127 · Jan 27, 2021
Provisional Application 62966723 · Jan 28, 2020
Related Publication 20230025189A1 · Jan 26, 2023
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