The beauty of better results with digital assays and AI-driven image analysis!
Our 21 CFR-part 11 compliant digital image analysis workflow ensures high-quality clinical insights. We provide detailed H&E and IHC/IF/ISH image analysis using advanced software with AI capabilities to support your clinical studies.
Discover the art of digital analysis!
CellCarta’s digital pathology expertise combines a meticulous digital assay workflow with comprehensive image analysis.
Complete H&E evaluations
Detailed image annotations
Strict quality checks by our analysts and pathologists
As a global CRO, we prioritize your study goals and clinical trial needs above all else. We aim to provide you with easy, accessible, and comprehensive technologies spanning a multitude of therapeutic areas.
The beauty of better results with digital assays and AI-driven image analysis!
Our 21 CFR-part 11 compliant digital image analysis workflow ensures high-quality clinical insights. We provide detailed H&E and IHC/IF/ISH image analysis using advanced software with AI capabilities to support your clinical studies.
Discover the art of digital analysis!
CellCarta’s digital pathology expertise combines a meticulous digital assay workflow with comprehensive image analysis.
Complete H&E evaluations
Detailed image annotations
Strict quality checks by our analysts and pathologists
As a global CRO, we prioritize your study goals and clinical trial needs above all else. We aim to provide you with easy, accessible, and comprehensive technologies spanning a multitude of therapeutic areas.
Comprehensive Histology and Pathology Services by CellCarta
November 22, 2022
Explore Our Advanced Histopathology Laboratories!
As a leading contract research organization (CRO), we offer a wide array of histopathology services.
Our histopathology facilities have trained in-house pathologists and multiple platforms to partner with you and provide integrated solutions for your specific clinical trial needs.
We deliver preclinical and clinical histology support to pharmaceutical and biotech sponsors worldwide.
Discover how CellCarta advances histopathology research and services.
We offer testing services for all phases of clinical trials including:
As a CAP/CLIA-certified CRO Lab, we support clinical studies for diagnostic and pharmaceutical partners in preparation for FDA, EU, and other global submissions.
Our digital pathology services and AI powered workflows provide scalable solutions for high-throughput histology testing across disease areas.
Histology CRO and Pathology CRO Services
Building on our comprehensive services, CellCarta’s Histology CRO capabilities extend to custom assay development and validation, supporting a wide range of clinical and research applications.
Our expert team provides histology support for CROs, offering tailored solutions to meet the specific requirements of each study. This includes detailed consultation on sample preparation, staining protocols, and data interpretation.
We offers both off-the-shelf and customized routine and advanced digital histology services, with an expert team ensuring reproducibility, scalability, and regulatory readiness.
Advanced Molecular and Digital Pathology Services
In addition to our core services, we provide advanced molecular pathology services, including in situ hybridization (ISH) and fluorescence in situ hybridization (FISH).
These techniques enable the detection of specific biomarkers and genetic materials within tissue samples, aiding in the identification and characterization of diseases.
Our digital pathology platforms, featuring whole slide imaging and automated image analysis, allows for accurate, reproducible data generation and efficient workflow management.
Collaborations and Software Solutions
We collaborate with industry leaders to enhance our service offerings and stay at the forefront of histopathology innovations.
Our histopathology software, including advanced AI-driven platforms, streamline data analysis and provide deeper insights into your samples.
This integration of cutting-edge technology ensures that our clients receive the most reliable and insightful data possible, ensuring CellCarta provides top CRO pathology services for your oncology, immunology, and biomarker programs regardless of disease area.
Quality Assurance and Global Compliance
Our commitment to quality goes beyond our technical capabilities. As a CAP/CLIA certified lab, we adhere to stringent quality control measures and global standards.
This ensures that our data and analyses are robust, reproducible, and ready for regulatory submissions worldwide, including FDA and EU approvals.
Our comprehensive quality assurance program includes regular proficiency testing and adherence to best practices in laboratory operations.
Why Choose CellCarta?
CellCarta offers unparalleled expertise in histopathology CRO services, making us a trusted partner for pharmaceutical companies and research institutions.
Whether you require IHC CRO services, digital pathology support, or full-service histopathology assay development, our team is equipped to deliver high-quality data.
Our comprehensive range of services, from routine histology to advanced molecular analyses, combined with our commitment to quality and innovation, ensures that we deliver accurate, high-quality data tailored to your specific needs.
Comprehensive Histology and Pathology Services by CellCarta
November 22, 2022
Explore Our Advanced Histopathology Laboratories!
As a leading contract research organization (CRO), we offer a wide array of histopathology services.
Our histopathology facilities have trained in-house pathologists and multiple platforms to partner with you and provide integrated solutions for your specific clinical trial needs.
We deliver preclinical and clinical histology support to pharmaceutical and biotech sponsors worldwide.
Discover how CellCarta advances histopathology research and services.
We offer testing services for all phases of clinical trials including:
As a CAP/CLIA-certified CRO Lab, we support clinical studies for diagnostic and pharmaceutical partners in preparation for FDA, EU, and other global submissions.
Our digital pathology services and AI powered workflows provide scalable solutions for high-throughput histology testing across disease areas.
Histology CRO and Pathology CRO Services
Building on our comprehensive services, CellCarta’s Histology CRO capabilities extend to custom assay development and validation, supporting a wide range of clinical and research applications.
Our expert team provides histology support for CROs, offering tailored solutions to meet the specific requirements of each study. This includes detailed consultation on sample preparation, staining protocols, and data interpretation.
We offers both off-the-shelf and customized routine and advanced digital histology services, with an expert team ensuring reproducibility, scalability, and regulatory readiness.
Advanced Molecular and Digital Pathology Services
In addition to our core services, we provide advanced molecular pathology services, including in situ hybridization (ISH) and fluorescence in situ hybridization (FISH).
These techniques enable the detection of specific biomarkers and genetic materials within tissue samples, aiding in the identification and characterization of diseases.
Our digital pathology platforms, featuring whole slide imaging and automated image analysis, allows for accurate, reproducible data generation and efficient workflow management.
Collaborations and Software Solutions
We collaborate with industry leaders to enhance our service offerings and stay at the forefront of histopathology innovations.
Our histopathology software, including advanced AI-driven platforms, streamline data analysis and provide deeper insights into your samples.
This integration of cutting-edge technology ensures that our clients receive the most reliable and insightful data possible, ensuring CellCarta provides top CRO pathology services for your oncology, immunology, and biomarker programs regardless of disease area.
Quality Assurance and Global Compliance
Our commitment to quality goes beyond our technical capabilities. As a CAP/CLIA certified lab, we adhere to stringent quality control measures and global standards.
This ensures that our data and analyses are robust, reproducible, and ready for regulatory submissions worldwide, including FDA and EU approvals.
Our comprehensive quality assurance program includes regular proficiency testing and adherence to best practices in laboratory operations.
Why Choose CellCarta?
CellCarta offers unparalleled expertise in histopathology CRO services, making us a trusted partner for pharmaceutical companies and research institutions.
Whether you require IHC CRO services, digital pathology support, or full-service histopathology assay development, our team is equipped to deliver high-quality data.
Our comprehensive range of services, from routine histology to advanced molecular analyses, combined with our commitment to quality and innovation, ensures that we deliver accurate, high-quality data tailored to your specific needs.
HER2-Low Breast Cancer: New Insights from Enhertu Clinical Trials
June 23, 2022
Nick Dupuis, Senior Director of Scientific Business Development
Recent results presented during the keynote address at the 2022 American Society of Clinical Oncology (ASCO) annual meeting highlighted the emergence of a new era for breast cancer treatment. The landmark study on the HER2-directed therapy, Enhertu, found that patients with HER2-negative breast cancer may soon have the opportunity to receive this new treatment based on exceptional outcomes in a Phase 3 clinical trial.
In this pivotal trial, patients with HER2-low metastatic breast cancer treated with Enhertu had a 49% lower risk of disease progression or death vs. patients treated with chemotherapy alone.1, 2 In most subgroups the progression free survival (PFS) was nearly doubled in the Enhertu arm vs. chemotherapy. HER2-positive tumors are routinely identified by pathologists using a combination of immunohistochemistry (IHC) tests and in situ hybridization (ISH). However, the trial results clearly demonstrated that HER2-low tumors (HER 1+ and 2+) also need clear identification, especially since they are more difficult to distinguish from HER2-negative with traditional methods. 2
Meeting the need for a more quantitative methodology
The Enhertu trial has identified a clear unmet need for more quantitative methodologies for HER2 detection, specifically the ability to distinguish low HER2, and potentially even “ultra low-HER2”, expressing populations, who will likely benefit from Enhertu treatment, from those that are truly negative.
To overcome the challenges of antibody-based IHC in detecting HER2-low metastatic breast cancer, CellCarta has developed a precision measurement approach leveraging mass spectrometry based Multiple Reaction Monitoring (MRM). The MRM platform has exceptional sensitivity, specificity, and quantitative precision to measure protein analytes, providing one of the most specific assays for protein measurement.
Exceptional specificity for detection of single or multiplexed cancer protein biomarkers
MRM offers absolute quantification and even provides accurate multiplexed quantitation of clinically relevant biomarkers such as HER2. CellCarta offers off-the-shelf multiplexed panels, including our MRM assay for HER2, or rapid development and validation of custom assays, depending on your study needs. We design and validate multiplexes of cancer protein biomarker panels of up to 15 proteins. All of our assays are validated for clinical use under CAP/CLIA and GCLP environments.
About the author:
Nick Dupuis is a Senior Director of Scientific Business Development at CellCarta, specialized in proteomics and biophysical measurement. He has held various roles in industry including as a scientist in LDT/IVD product and applications development, and business development for emerging analytical platforms.
References
Modi S, Jacot W, Yamashita T, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. NEJM 2022;doi:10.1056/NEJMoa2203690.
HER2-Low Breast Cancer: New Insights from Enhertu Clinical Trials
June 23, 2022
Nick Dupuis, Senior Director of Scientific Business Development
Recent results presented during the keynote address at the 2022 American Society of Clinical Oncology (ASCO) annual meeting highlighted the emergence of a new era for breast cancer treatment. The landmark study on the HER2-directed therapy, Enhertu, found that patients with HER2-negative breast cancer may soon have the opportunity to receive this new treatment based on exceptional outcomes in a Phase 3 clinical trial.
In this pivotal trial, patients with HER2-low metastatic breast cancer treated with Enhertu had a 49% lower risk of disease progression or death vs. patients treated with chemotherapy alone.1, 2 In most subgroups the progression free survival (PFS) was nearly doubled in the Enhertu arm vs. chemotherapy. HER2-positive tumors are routinely identified by pathologists using a combination of immunohistochemistry (IHC) tests and in situ hybridization (ISH). However, the trial results clearly demonstrated that HER2-low tumors (HER 1+ and 2+) also need clear identification, especially since they are more difficult to distinguish from HER2-negative with traditional methods. 2
Meeting the need for a more quantitative methodology
The Enhertu trial has identified a clear unmet need for more quantitative methodologies for HER2 detection, specifically the ability to distinguish low HER2, and potentially even “ultra low-HER2”, expressing populations, who will likely benefit from Enhertu treatment, from those that are truly negative.
To overcome the challenges of antibody-based IHC in detecting HER2-low metastatic breast cancer, CellCarta has developed a precision measurement approach leveraging mass spectrometry based Multiple Reaction Monitoring (MRM). The MRM platform has exceptional sensitivity, specificity, and quantitative precision to measure protein analytes, providing one of the most specific assays for protein measurement.
Exceptional specificity for detection of single or multiplexed cancer protein biomarkers
MRM offers absolute quantification and even provides accurate multiplexed quantitation of clinically relevant biomarkers such as HER2. CellCarta offers off-the-shelf multiplexed panels, including our MRM assay for HER2, or rapid development and validation of custom assays, depending on your study needs. We design and validate multiplexes of cancer protein biomarker panels of up to 15 proteins. All of our assays are validated for clinical use under CAP/CLIA and GCLP environments.
About the author:
Nick Dupuis is a Senior Director of Scientific Business Development at CellCarta, specialized in proteomics and biophysical measurement. He has held various roles in industry including as a scientist in LDT/IVD product and applications development, and business development for emerging analytical platforms.
References
Modi S, Jacot W, Yamashita T, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. NEJM 2022;doi:10.1056/NEJMoa2203690.
