#-supreme-cellcarta-card-grid-7-733{cards-data:[{"image_url":"https://cellcarta.com/wp-content/uploads/2026/07/CellCarta-JBF-MRD-2026-AO-poster-final-6.png","image_alt":"Mass spectrometry M-protein measurement case study","stamp":"Case Study","title":"M-Protein Measurement Using Mass Spectrometry","description":"

CellCarta presents a High-Resolution Mass Spectrometry (HRMS) workflow to measure M-protein levels from as little as 10 µL of blood samples taken from multiple myeloma patients. This represents a non-invasive,sensitive,and precise quantification method that can be employed for oncology research.

","stat_1_value":"","stat_1_label":"","stat_2_value":"","stat_2_label":"","stat_3_value":"","stat_3_label":"","button_text":"Learn More","button_url":"/science-hub/mprotein-multiplemyeloma-massspectrometry/"},{"image_url":"https://cellcarta.com/wp-content/uploads/2026/07/Validating-an-NSCLC-Assay.jpg","image_alt":"NSCLC assay validation for clinical trials case study","stamp":"Case Study","title":"Validating an NSCLC Assay for Clinical Trials","description":"CellCarta validated the ultra-sensitive assay,Aspyre Lung by Biofidelity,as a clinical trial assay for non-small cell lung cancer (NSCLC) using PCR. Aspyre Lung is an accurate and rapid assay that can be implemented in clinical trials for non-invasive patient management.","stat_1_value":"","stat_1_label":"","stat_2_value":"","stat_2_label":"","stat_3_value":"","stat_3_label":"","button_text":"Learn More","button_url":"/science-hub/biomarker-assay-validation-nsclc-cta/"}]}#-supreme-cellcarta-differentiators-8-733{items-data:[{"text":"Customized Solutions"},{"text":"Regulatory-Ready Data"},{"text":"Global Coverage"},{"text":"Multi-Platform Data"},{"text":"Expertise Across Indications"}]}#-supreme-cellcarta-faq-11-733{items-data:[{"faq_question":"What is the difference between using a specialized biomarker CRO and a central lab for an oncology trial?","faq_answer":"

A central lab handles routine safety chemistry,hematology,and standardized diagnostics. Meanwhile,a specialized biomarker CRO supports assay development and regulatory submission for clinical integration. Whether these assays are developed for exploratory use or intended for CDx deployment,a specialized biomarker CRO can accommodate their full range of clinical utility.

For biomarker-driven oncology trials,especially those with CDx co-development,sponsors typically require specialist capability beyond the central lab scope. At CellCarta,we operate eight globally harmonized specialist facilities supporting biomarker,bioanalytical,and CDx workflows end-to-end.

"},{"faq_question":"What should sponsors look for when evaluating a biomarker CRO for an oncology program?","faq_answer":"

Sponsors should evaluate four dimensions:scientific depth across relevant modalities (checkpoint inhibitors,antibody-drug conjugates,cell therapies),breadth of validated assay platforms (flow and mass cytometry,mass spectrometry,digital pathology,genomics),companion diagnostic experience including prior regulatory submissions,and global lab harmonization to support multi-site trials. Track record matters,including number of programs supported,modality coverage,and quality accreditations. At CellCarta,we bring 25+ years of biomarker experience,CDx expertise,and 750+ employees,40% of which have a MSc,PhD,or MD.

"},{"faq_question":"What biomarker services are typically needed across an oncology drug development program?","faq_answer":"

Oncology biomarker programs typically require an integrated suite of services spanning immune monitoring (flow cytometry,mass cytometry,ELISpot,receptor occupancy),proteomics and bioanalytical mass spectrometry,genomics (actionable genomic alterations,comprehensive genomic profiling,tumor mutational burden,microsatellite instability,circulating tumor DNA),and digital pathology with multiplex imaging. As programs advance,companion diagnostic development and validation become critical for patient selection. CellCarta delivers these services across eight globally harmonized facilities supporting discovery through regulatory submissions.

"},{"faq_question":"What quality standards and accreditations should an oncology biomarker partner hold?","faq_answer":"

An oncology biomarker partner should hold clinical laboratory accreditations recognized by major regulators—including the U.S. CAP and CLIA standards for clinical assay reporting,good clinical laboratory practice standards for exploratory biomarker work,and international equivalents such as ISO 15189 for global labs. Companion diagnostic capability requires quality systems aligned to FDA and EU IVDR requirements. Multi-site harmonization and demonstrated cross-lab reproducibility are equally important. CellCarta’s global facilities operate under harmonized quality systems,supporting global regulatory submissions.

"},{"faq_question":"How early should sponsors engage a biomarker CRO in an oncology development program?","faq_answer":"

Sponsors typically benefit from engaging a biomarker CRO during late discovery or early translational development,before first-in-human studies,to align the biomarker strategy with the asset’s mechanism,modality,and target patient population. Early engagement allows time to develop and validate fit-for-purpose assays,plan companion diagnostic strategies where required,and design biomarker collection that supports later regulatory submissions. Late engagement often constrains assay choice and limits CDx feasibility. CellCarta partners with sponsors from discovery through CDx development across oncology programs.

"}]}#-supreme-cellcarta-featured-resources-12-753{cards-data:[{"image_url":"https://cellcarta.com/wp-content/uploads/2026/04/LKF-Blog-posts-5-1024x341-1.webp","image_alt":"","card_type":"","date":"Apr 14,2026","reading_time":"","title":"Emerging ADC Biomarkers","description":"","url":"/science-hub/emerging-biomarkers-shaping-the-next-generation-of-adc-therapies/","link_target":"_self"},{"image_url":"https://cellcarta.com/wp-content/uploads/2026/04/CellCarta_Pillar_PressRelease-300x300-1.png","image_alt":"","card_type":"","date":"Apr 7,2026","reading_time":"","title":"CellCarta and Pillar Biosciences Announce Multi-Year Global Strategic Partnership to Expand Rapid,Decentralized Tumor Profiling for Oncology Clinical Trials","description":"Lorem ipsum dolor sit amet,consectetuer adipiscing elit. Aenean commodo ligula eget dolor.","url":"/news/cellcarta-and-pillar-biosciences-announce-multi-year-global-strategic-partnership-to-expand-rapid-decentralized-tumor-profiling-for-oncology-clinical-trials/","link_target":"_self"},{"image_url":"https://cellcarta.com/wp-content/uploads/2026/07/Cellcarta-Tagline_logo.jpg","image_alt":"Feb 17,2025","card_type":"","date":"Feb 17,2025","reading_time":"","title":"A Phase I Study of FHD-609,a Heterobifunctional Degrader of Bromodomain-Containing Protein 9,in Patients with Advanced Synovial Sarcoma or SMARCB1-Deficient Tumors","description":"","url":"https://pubmed.ncbi.nlm.nih.gov/39660994/","link_target":"_blank"}]}#-supreme-cellcarta-indications-4-733{cards-data:[{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Breast-Cancer-03.jpg","image_alt":"Breast cancer biomarker profiling","title":"Breast Cancer","description":"HER2,TROP2,and FOLR1 target expression profiling alongside TIL quantification and PK/ADA assays."},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/NSCLC-497.jpg","image_alt":"NSCLC biomarker assay development","title":"NSCLC","description":"PD-L1,ALK,EGFR,and ROS1 biomarker assay development with ctDNA monitoring and CDx pathway support."},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Multiple-Myeloma-128.jpg","image_alt":"Multiple myeloma bioanalytical assays","title":"Multiple Myeloma","description":"BCMA plasma monitoring,immune cell profiling,and MS-based bioanalytical assays for clinical endpoints."},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Ovarian-Cancer-04.jpg","image_alt":"Ovarian cancer spatial TME profiling","title":"Ovarian Cancer","description":"FOLR1 target expression,spatial TME profiling,and IHC-based companion diagnostic development."},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Urothelial-Cancer-05.jpg","image_alt":"Urothelial cancer CDx support","title":"Urothelial Cancer","description":"PD-L1 biomarker validation and IHC-based CDx support,with published expertise from the ABACUS trial."}]}#-supreme-cellcarta-overview-3-733{stats-data:[{"number":"25+","label":"Years of expertise"},{"number":"8","label":"Global facilities"},{"number":"750+","label":"Employees"}]}#-supreme-cellcarta-tab-content-5-733{tabs-data:[{"tab_title":"Immune Insights","content_title":"","content_body":"

Understanding the tumor immune microenvironment (TME) requires a precise understanding of immune cell populations and signaling pathways. Our immune monitoring capabilities include:

Measuring immune checkpoint proteins,including PD-1,LAG-3,and PD-L1,using flow cytometry
High-content immune cell monitoring by mass cytometry
Monitoring target engagement of therapeutic antibodies using receptor occupancy assay
Measuring cytokine-secreting cells by ELISpot

","tab_image":"https://cellcarta.com/wp-content/uploads/2026/07/CellCarta_-59-scaled.jpg","image_alt":"Immune monitoring laboratory"},{"tab_title":"Biomarker Discovery","content_title":"","content_body":"

Identifying and quantifying protein biomarkers in oncology requires both depth of discovery and analytical precision.

Our mass spectrometry (MS)-based workflows support identification of neo-epitopes,drug targets,and candidate biomarkers in all relevant biological matrices.

For in-depth spatial analysis,we can incorporate the Lunaphore COMET™for immune cell identification,single-cell phenotyping,and protein interaction investigations.

","tab_image":"https://cellcarta.com/wp-content/uploads/2026/07/CellCarta_-8-2-1-scaled.jpg","image_alt":"Proteomics mass spectrometry laboratory"},{"tab_title":"Oncogene Analysis","content_title":"","content_body":"

Molecular profiling of tumors is critical for patient stratification,monitoring treatment response,and therapeutic development.

Our scientists support oncology programs through in-depth genomic analysis,including:

Whole genome and exome sequencing using next-generation sequencing (NGS) platforms
Actionable genomic alterations (AGAs) detection by dPCR,qPCR,and NGS
Gene expression assessed by NanoString
Tumor microenvironment analysis with spatial biology

","tab_image":"https://cellcarta.com/wp-content/uploads/2026/06/Digital-PCR-dPCR-539.jpg","image_alt":"Genomics sequencing laboratory"},{"tab_title":"CDx Scalability","content_title":"","content_body":"

Companion diagnostic (CDx) development demands regulatory precision,scientific rigor,and a partner who has navigated that path before.

CellCarta supports the full CDx lifecycle from assay conceptualization through analytical validation,offering IHC,molecular,and MS-based solutions for oncology indications.

Read about our CDx Accelerator model here.

","tab_image":"https://cellcarta.com/wp-content/uploads/2026/06/CDx-tab-21.jpg","image_alt":"Companion diagnostics development laboratory"}];cards-data:[{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Breast-Cancer-03.jpg","image_alt":"Breast cancer biomarker profiling","title":"Breast Cancer","description":"HER2,TROP2,and FOLR1 target expression profiling alongside TIL quantification and PK/ADA assays."},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/NSCLC-497.jpg","image_alt":"NSCLC biomarker assay development","title":"NSCLC","description":"PD-L1,ALK,EGFR,and ROS1 biomarker assay development with ctDNA monitoring and CDx pathway support."},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Multiple-Myeloma-128.jpg","image_alt":"Multiple myeloma bioanalytical assays","title":"Multiple Myeloma","description":"BCMA plasma monitoring,immune cell profiling,and MS-based bioanalytical assays for clinical endpoints."},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Ovarian-Cancer-04.jpg","image_alt":"Ovarian cancer spatial TME profiling","title":"Ovarian Cancer","description":"FOLR1 target expression,spatial TME profiling,and IHC-based CDx development."},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Urothelial-Cancer-05.jpg","image_alt":"Urothelial cancer CDx support","title":"Urothelial Cancer","description":"PD-L1 biomarker validation and IHC-based CDx support,with published expertise from the ABACUS trial."}];oxy-supreme-cellcarta-tab-content-cards-data:[{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Breast-Cancer-03.jpg","image_alt":"Breast cancer biomarker profiling","title":"Breast Cancer","description":"HER2,TROP2,and FOLR1 target expression profiling alongside TIL quantification and PK/ADA assays."},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/NSCLC-497.jpg","image_alt":"NSCLC biomarker assay development","title":"NSCLC","description":"PD-L1,ALK,EGFR,and ROS1 biomarker assay development with ctDNA monitoring and CDx pathway support."},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Multiple-Myeloma-128.jpg","image_alt":"Multiple myeloma bioanalytical assays","title":"Multiple Myeloma","description":"BCMA plasma monitoring,immune cell profiling,and MS-based bioanalytical assays for clinical endpoints."},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Ovarian-Cancer-04.jpg","image_alt":"Ovarian cancer spatial TME profiling","title":"Ovarian Cancer","description":"FOLR1 target expression,spatial TME profiling,and IHC-based CDx development."},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Urothelial-Cancer-05.jpg","image_alt":"Urothelial cancer CDx support","title":"Urothelial Cancer","description":"PD-L1 biomarker validation and IHC-based CDx support,with published expertise from the ABACUS trial."}]}#-supreme-cellcarta-technology-6-733{cards-data:[{"card_title":"Flow Cytometry","card_image":"https://cellcarta.com/wp-content/uploads/2026/06/Flow-Cytometry-Services-118.jpg","image_alt":"Flow cytometry technology","card_description":"

Spectral and conventional platforms with up to 40 parameters per cell. Validated checkpoint,TIL,CAR-T,and receptor occupancy panels across global sites.

","card_link":"/platforms/flow-cytometry/","card_link_text":"Explore flow cytometry"},{"card_title":"Sequencing Services","card_image":"https://cellcarta.com/wp-content/uploads/2026/07/CellCarta-802-1-scaled.jpg","image_alt":"Next-generation sequencing platform","card_description":"

Comprehensive genomic and transcriptomic profiling,including whole genome and exome sequencing,ctDNA/MRD tracking,RNA sequencing,and single-cell sequencing,supporting all stages of therapeutic development.

","card_link":"/capabilities/genomics/sequencing-services/","card_link_text":"Explore sequencing services"},{"card_title":"Digital Pathology","card_image":"https://cellcarta.com/wp-content/uploads/2026/07/CellCarta-528-scaled.jpg","image_alt":"Digital pathology spatial analysis","card_description":"

Multiplex IHC/IF with spatial analysis for tumor microenvironment profiling. Board-certified pathologists and AI-assisted image analysis.

","card_link":"/capabilities/histopathology/digital-pathology/","card_link_text":"Explore digital pathology"}]}