IP Library Granted Patent US 12,579,645
Granted Patent B2
US 12,579,645 · App. 18/451,507 · Granted Mar 17, 2026

Systems and methods for processing images to determine biomarker levels

Inventors: Jillian Sue (New York, NY); Marc Goldfinger (London, GB); Brandon Rothrock (Los Angeles, CA); Matthew Lee (London, GB)
Assignee: Paige.AI, Inc.
G06T7/0012G06T5/50G06V10/462G16H30/20G16H30/40G06T2207/20221G06T2207/30024G06T2207/30068
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Quick Facts
Patent No.
US 12,579,645
App. No.
18/451,507
Granted
Mar 17, 2026
Kind
B2
Abstract

Systems and methods are described herein for processing electronic medical images to predict a biomarker's presence, including receiving one or more digital medical images, the one or more digital medical images being of at least one pathology specimen associated with a patient. A machine learning system may determine a biomarker expression level prediction for the one or more digital medical images. The biomarker expression level prediction may be based on a determined transcriptomic score and protein expression score for the one or more digital medical images. A slide overlay indicating a region of tissue on the one or more digital medical images that is most likely to contribute to the slide level biomarker expression prediction may be generated.

Claims (39)

1 . A computer-implemented method for processing electronic medical images to predict a biomarker's presence, comprising:

receiving one or more digital medical images, the one or more digital medical images being of at least one pathology specimen associated with a patient;

determining a protein expression score for the one or more digital medical images, the protein expression score including an immunohistochemistry (IHC) score for each of the one or more digital medical images;

determining a transcriptomic score including a level of Erb-B2 Receptor Tyrosine Kinase 2 (ERBB2) mRNA;

determining, by a machine learning system, a biomarker expression level prediction for the one or more digital medical images, the biomarker expression level prediction being based on the transcriptomic score and the protein expression score for the one or more digital medical images, wherein the biomarker expression level prediction is determined to be a true absence of human epidermal growth factor receptor 2 (HER2) expression upon determining that the immunohistochemistry score is IHC-0+, indeterminate, or equivocal-IHC-1+ and that the ERBB2 mRNA level is less than a predetermined value; and

generating a slide overlay indicating a region of tissue on the one or more digital medical images that contributes to the biomarker expression level prediction.

2 . The method of claim 1 , further comprising:

determining, salient regions of the received one or more digital medical images prior to determining the biomarker expression level, wherein non-salient image regions are excluded from subsequent processing.

3 . The method of claim 2 , wherein the one or more salient regions correspond to cancerous tissue.

4 . The method of claim 1 , wherein the one or more digital medical images are images of breast tissue stained with hematoxylin and eosin.

5 . The method of claim 1 , wherein the biomarker expression is human epidermal growth factor receptor 2.

6 . The method of claim 1 , wherein the biomarker expression level prediction is performed upon determining that the received one or more slides has a immunohistochemistry (IHC) score of IHC-0 or IHC-1.

7 . The method of claim 1 , wherein the predetermined value of ERBB2 mRNA is 7.6.

8 . The method of claim 1 , wherein generating a slide overlay includes generating a tissue map overlay and/or a heatmap overlay.

9 . A system for processing electronic medical images, the 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 medical images, the one or more digital medical images being of at least one pathology specimen associated with a patient;

determining a protein expression score for the one or more digital medical images, the protein expression score including an immunohistochemistry (IHC) score for each of the one or more digital medical images;

determining a transcriptomic score including a level of Erb-B2 Receptor Tyrosine Kinase 2 (ERBB2) mRNA;

determining, by a machine learning system, a biomarker expression level prediction for the one or more digital medical images, the biomarker expression level prediction being based on the transcriptomic score and the protein expression score for the one or more digital medical images, wherein the biomarker expression level prediction is determined to be a true absence of human epidermal growth factor receptor 2 (HER2) expression upon determining that the immunohistochemistry score is IHC-0+, indeterminate, or equivocal-IHC-1+ and that the ERBB2 mRNA level is less than a predetermined value; and

generating a slide overlay indicating a region of tissue on the one or more digital medical images that contributes to the biomarker expression level prediction.

10 . The system of claim 9 , further comprising:

determining, salient regions of the received one or more digital medical images prior to determining the biomarker expression level, wherein non-salient image regions are excluded from subsequent processing.

11 . The system of claim 10 , wherein the one or more salient regions correspond to cancerous tissue.

12 . The system of claim 9 , wherein the biomarker expression level prediction is performed upon determining that the received one or more slides has a immunohistochemistry (IHC) score of IHC-0 or IHC-1.

13 . The system of claim 9 , wherein the one or more digital medical images are images of breast tissue stained with hematoxylin and eosin.

14 . The system of claim 9 , wherein the predetermined value is predetermined value of ERBB2 mRNA is 7.6.

15 . A non-transitory computer-readable medium storing instructions that, when executed by a processor, perform operations processing electronic medical images, the operations comprising:

receiving one or more digital medical images, the one or more digital medical images being of at least one pathology specimen associated with a patient;

determining a protein expression score for the one or more digital medical images, the protein expression score including an immunohistochemistry (IHC) score for each of the one or more digital medical images;

determining a transcriptomic including a level of Erb-B2 Receptor Tyrosine Kinase 2 (ERBB2) mRNA;

determining, by a machine learning system, a biomarker expression level prediction for the one or more digital medical images, the biomarker expression level prediction being based on the transcriptomic score and the protein expression score for the one or more digital medical images, wherein the biomarker expression level prediction is determined to be a true absence of human epidermal growth factor receptor 2 (HER2) expression upon determining that the immunohistochemistry score is IHC-0+, indeterminate, or equivocal-IHC-1+ and that the ERBB2 mRNA level is less than a predetermined value; and

generating a slide overlay indicating a region of tissue on the one or more digital medical images that contributes to the biomarker expression level prediction.

16 . The non-transitory computer-readable medium of claim 15 , further comprising:

determining, salient regions of the received one or more digital medical images prior to determining the biomarker expression level, wherein non-salient image regions are excluded from subsequent processing.

17 . The non-transitory computer-readable medium of claim 16 , wherein the one or more salient regions correspond to cancerous tissue.

18 . The non-transitory computer-readable medium of claim 15 , wherein the one or more digital medical images are images of breast tissue stained with hematoxylin and eosin.

19 . The non-transitory computer-readable medium of claim 15 , wherein the predetermined value of ERBB2 mRNA is 7.6.

Assignments (4)
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 Dec 20, 2023
From: SUE, JILLIAN; GOLDFINGER, MARC; ROTHROCK, BRANDON; LEE, MATTHEW
To: PAIGE.AI, INC.
Reel/Frame 065920/0911 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 23, 2023
From: SUE, JILLIAN; GOLDFINGER, MARC
To: PAIGE.AI, INC.
Reel/Frame 064686/0852 →
Continuity (2)
Provisional Application 63399150 · Aug 18, 2022
Related Publication 20240062372A1 · Feb 22, 2024
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