Biomarker Strategies for Cell Therapy in Autoimmune Diseases

October 16, 2024

Biomarker Strategies for Cell Therapy in Autoimmune Diseases Measuring the B Cell Reset

Biomarker Strategies for Cell Therapy in Autoimmune Diseases

October 16, 2024

Biomarker Strategies for Cell Therapy in Autoimmune Diseases Measuring the B Cell Reset

Let's Talk: A Conversation with Dr. Scott Gottlieb

September 10, 2024

The drug development landscape is rapidly evolving, with new regulatory guidance, novel therapy types, and exciting AI-powered technologies altering the face of clinical testing.

In this webcast, Scott Gottlieb, former FDA commissioner, joins Christopher Ung, our Chief Scientific Business Officer, for an in-depth conversation on the latest in regulatory and biomarker development.

Key topics discussed in this webcast:

  • The history and future of cell therapies
  • The FDA’s final rule to regulate lab-developed IVDs as medical devices
  • How to navigate the FDA’s new oncology IVD pilot program
  • T cell health in immune oncology and metabolic drug development
  • How AI-powered digital pathology is revolutionizing cell therapy development
author photo

Dr. Gottlieb is a physician and served as the 23rd Commissioner of the U.S. Food and Drug Administration. Dr. Gottlieb’s work focuses on advancing public health through developing and implementing innovative approaches to improve medical outcomes, reshape healthcare delivery, and expand consumer choice and safety. He is currently a partner at the venture capital firm New Enterprise Associates; a resident fellow at the American Enterprise Institute; a contributor to CNBC; and a board member to Pfizer, Inc. and Illumina, Inc.

author photo

Christopher Ung is CellCarta’s Chief Scientific Business Officer and has served in the companion diagnostics field since its inception. He is one of the original pioneers of the personalized medicine field. Mr. Ung currently leads the development and execution of CellCarta’s strategic and business initiatives, leveraging the company’s solid tumor and anatomic pathology services.

Let's Talk: A Conversation with Dr. Scott Gottlieb

September 10, 2024

The drug development landscape is rapidly evolving, with new regulatory guidance, novel therapy types, and exciting AI-powered technologies altering the face of clinical testing.

In this webcast, Scott Gottlieb, former FDA commissioner, joins Christopher Ung, our Chief Scientific Business Officer, for an in-depth conversation on the latest in regulatory and biomarker development.

Key topics discussed in this webcast:

  • The history and future of cell therapies
  • The FDA’s final rule to regulate lab-developed IVDs as medical devices
  • How to navigate the FDA’s new oncology IVD pilot program
  • T cell health in immune oncology and metabolic drug development
  • How AI-powered digital pathology is revolutionizing cell therapy development
author photo

Dr. Gottlieb is a physician and served as the 23rd Commissioner of the U.S. Food and Drug Administration. Dr. Gottlieb’s work focuses on advancing public health through developing and implementing innovative approaches to improve medical outcomes, reshape healthcare delivery, and expand consumer choice and safety. He is currently a partner at the venture capital firm New Enterprise Associates; a resident fellow at the American Enterprise Institute; a contributor to CNBC; and a board member to Pfizer, Inc. and Illumina, Inc.

author photo

Christopher Ung is CellCarta’s Chief Scientific Business Officer and has served in the companion diagnostics field since its inception. He is one of the original pioneers of the personalized medicine field. Mr. Ung currently leads the development and execution of CellCarta’s strategic and business initiatives, leveraging the company’s solid tumor and anatomic pathology services.

MHC Class II Predicts Anti-PD-L1 Response in Urothelial Cancer

May 28, 2024

CellCarta’s poster, presented at ASCO 2024, discusses the study on tumor-specific MHC class II upregulation in patients with urothelial cancer undergoing anti-PD-L1 therapy.

The study, part of the abacus trial (NCT02662309), revealed that MHC class II expression in tumor cells, although rare, is associated with a positive response to atezolizumab. Utilizing spatial transcriptomics and immunohistochemistry (IHC), the research highlighted significant differences in MHC II expression between patients with pathological complete response (pCR) and those with major pathological response (MPR) or relapse.

The findings suggest that MHC II expression could serve as a biomarker for predicting therapeutic outcomes in bladder cancer treatment.

View the full poster:

Tumor-specific MHC class II upregulation associated with response to anti-PD-L1 therapy in patients with urothelial cancer

MHC Class II Upregulation Predicts Anti-PD-L1 Therapy Response in Urothelial Cancer

MHC Class II Predicts Anti-PD-L1 Response in Urothelial Cancer

May 28, 2024

CellCarta’s poster, presented at ASCO 2024, discusses the study on tumor-specific MHC class II upregulation in patients with urothelial cancer undergoing anti-PD-L1 therapy.

The study, part of the abacus trial (NCT02662309), revealed that MHC class II expression in tumor cells, although rare, is associated with a positive response to atezolizumab. Utilizing spatial transcriptomics and immunohistochemistry (IHC), the research highlighted significant differences in MHC II expression between patients with pathological complete response (pCR) and those with major pathological response (MPR) or relapse.

The findings suggest that MHC II expression could serve as a biomarker for predicting therapeutic outcomes in bladder cancer treatment.

View the full poster:

Tumor-specific MHC class II upregulation associated with response to anti-PD-L1 therapy in patients with urothelial cancer

MHC Class II Upregulation Predicts Anti-PD-L1 Therapy Response in Urothelial Cancer

M-Protein Analysis in Myeloma via Mass Spectrometry

May 4, 2024

CellCarta’s poster on M-Protein analysis in plasma of multiple myeloma (MM) patients highlights the use of intact mass spectrometry for monitoring disease progression. This non-invasive method, requiring only a small volume of plasma or serum, measures M-Protein levels with high sensitivity, precision, and reproducibility.

The study demonstrated that mass spectrometry could detect significant reductions in M-Protein concentration, providing an effective alternative to bone marrow biopsies for evaluating treatment response and measurable residual disease (MRD). The workflow supports high-frequency sampling, offering a comprehensive profile of disease progression and treatment efficacy in MM patients.

View the poster

M-Protein Analysis in Plasma of Multiple Myeloma Patients by Intact Mass Spectrometry

M-Protein Analysis in Plasma of Multiple Myeloma Patients by Intact Mass Spectrometry

M-Protein Analysis in Myeloma via Mass Spectrometry

May 4, 2024

CellCarta’s poster on M-Protein analysis in plasma of multiple myeloma (MM) patients highlights the use of intact mass spectrometry for monitoring disease progression. This non-invasive method, requiring only a small volume of plasma or serum, measures M-Protein levels with high sensitivity, precision, and reproducibility.

The study demonstrated that mass spectrometry could detect significant reductions in M-Protein concentration, providing an effective alternative to bone marrow biopsies for evaluating treatment response and measurable residual disease (MRD). The workflow supports high-frequency sampling, offering a comprehensive profile of disease progression and treatment efficacy in MM patients.

View the poster

M-Protein Analysis in Plasma of Multiple Myeloma Patients by Intact Mass Spectrometry

M-Protein Analysis in Plasma of Multiple Myeloma Patients by Intact Mass Spectrometry

Enumerating Large Oncosomes with RareCyte CTC Platform

April 8, 2024

CellCarta’s proof-of-concept study utilizes the RareCyte CTC platform to enumerate large oncosomes (LOs) in patients with HER2 overexpressing tumors.

The study demonstrates that combining circulating tumor cells (CTCs), LOs, and circulating cell-free DNA (cfDNA) in a multimodal liquid biopsy analysis enhances the detection and monitoring of HER2 amplification in metastatic breast cancer.

The results showed a strong correlation between LO count and CTC count, and the combined analysis improved the accuracy of HER2 status assessment. This approach offers a cost-efficient and non-invasive method to monitor tumor biomarkers, providing valuable insights into tumor progression and treatment response.

View the poster:

Proof-of-concept study to enumerate large oncosomes using the RareCyte CTC platform

Proof-of-concept study to enumerate large oncosomes using the (visual)

 

Enumerating Large Oncosomes with RareCyte CTC Platform

April 8, 2024

CellCarta’s proof-of-concept study utilizes the RareCyte CTC platform to enumerate large oncosomes (LOs) in patients with HER2 overexpressing tumors.

The study demonstrates that combining circulating tumor cells (CTCs), LOs, and circulating cell-free DNA (cfDNA) in a multimodal liquid biopsy analysis enhances the detection and monitoring of HER2 amplification in metastatic breast cancer.

The results showed a strong correlation between LO count and CTC count, and the combined analysis improved the accuracy of HER2 status assessment. This approach offers a cost-efficient and non-invasive method to monitor tumor biomarkers, providing valuable insights into tumor progression and treatment response.

View the poster:

Proof-of-concept study to enumerate large oncosomes using the RareCyte CTC platform

Proof-of-concept study to enumerate large oncosomes using the (visual)