CellCarta presents a High-Resolution Mass Spectrometry (HRMS) workflow to measure M-protein levels from as little as 10 µL of sample. This is a non-invasive,sensitive,and precise quantification method that can be employed for clinical oncology research.
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","stat_1_value":"","stat_1_label":"","stat_2_value":"","stat_2_label":"","stat_3_value":"","stat_3_label":"","button_text":"Read the Case Study","button_url":"/science-hub/pathologist-scoring-method-immune-phenotype-carcinoma/"}]}#-supreme-cellcarta-challenge-4-742{bullets-data:[{"text":"Full biomarker program coverage across immune monitoring,proteomics,genomics,and histopathology"},{"text":"Custom assay development and validation"},{"text":"Owned,harmonized laboratories in the US,Canada,Belgium,China,and Australia for global reach"},{"text":"CAP-accredited,CLIA-certified testing environments across all sites"},{"text":"Rigorous QA/QC processes"},{"text":"A clear pathway to companion diagnostic development"}];cards-data:[{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Quality-Management-785.jpg","image_alt":"Quality management laboratory","title":"Quality Management","desc":"Generate data that meets global regulatory standards with CellCarta’s quality management system (QMS),implemented at every level of the organization.
Test with confidence in laboratories that meet the highest international standards.
Protect sample integrity at every stage with meticulous,end-to-end,real-time sample management.
Generate data that meets global regulatory standards with CellCarta’s quality management system (QMS),implemented at every level of the organization.
Test with confidence in laboratories that meet the highest international standards.
Protect sample integrity at every stage with meticulous,end-to-end,real-time sample management.
Generate data that meets global regulatory standards with CellCarta’s quality management system (QMS),implemented at every level of the organization.
\nTest with confidence in laboratories that meet the highest international standards.
\nProtect sample integrity at every stage with meticulous,end-to-end sample management.
\nBiomarker services are integrated scientific offerings that identify,develop,validate,and measure biological indicators used to guide clinical development,patient stratification,and regulatory decisions. They are critical because biomarkers serve as diagnostic,prognostic,or predictive tools that reduce failure rates in drug development and support FDA,EMA,PMDA,and NMPA submissions.
\nCellCarta delivers end-to-end biomarker solutions across various therapeutic areas and capabilities,combining discovery,assay development,validation,and clinical testing under one program. This integrated model reduces vendor fragmentation,protects data integrity,and accelerates go/no-go decisions from Phase I through Phase IV.
"},{"faq_question":"Which biomarker platforms and technologies does CellCarta use?","faq_answer":"CellCarta offers end-to-end biomarker services spanning biomarker discovery,assay development and customization,fit-for-purpose validation,clinical sample analysis,and companion diagnostic (CDx) development. Services run across our validated platforms:flow cytometry (TBNK,MDSC),mass cytometry (CyTOF,up to 40 markers),ELISpot and FluoroSpot,multiplexed immunoassays on MSD®,Olink™,and Ella™,histopathology with multiplex IHC,ISH,and digital pathology,molecular assays for DNA and RNA,and mass spectrometry for proteomics. Every project is led by PhD-level scientists and executed in GCLP and CAP-accredited,CLIA-certified global laboratories.
"},{"faq_question":"Are CellCarta’s biomarker services GCLP,CAP,and CLIA compliant?","faq_answer":"Yes. CellCarta delivers biomarker services in GCLP-compliant,CAP-accredited,CLIA-certified testing sites across our globally owned facilities. CAP accreditation is recognized by CMS as meeting or exceeding CLIA requirements,and GCLP bridges GLP and GCP for clinical trial sample analysis,covering pre-analytical,analytical,and post-analytical processes.
\nEvery assay follows documented SOPs,validated data management systems,and harmonized protocols,producing data suitable for FDA,EMA,PMDA,and NMPA submissions and for progression toward companion diagnostic qualification. Sponsors running multi-region studies benefit from directly comparable data without requalification across sites.
"},{"faq_question":"What is the difference between biomarker discovery and biomarker validation?","faq_answer":"Biomarker discovery identifies candidate biological indicators correlated with disease,treatment response,or safety,typically using exploratory,high-content platforms such as mass cytometry,proteomics,or NGS. Biomarker validation confirms that a selected candidate is accurate,reproducible,and fit for intended use,through analytical and clinical validation aligned with FDA BMV,ICH M10,and ISO 15189 expectations. CellCarta covers both stages within one biomarker solutions organization,so candidates identified during discovery move seamlessly into method development,fit-for-purpose validation,and regulated clinical deployment,reducing transfer risk and shortening program timelines.
"}]}#-supreme-cellcarta-featured-resources-8-742{cards-data:[{"card_type":"Poster","date":"March 3,2026","reading_time":"","title":"Validation of an ultra-sensitive assay for biomarker testing in NSCLC patients as Clinical Trial Assay (CTA)","description":"","url":"https://cellcarta.com/science-hub/biomarker-assay-validation-nsclc-cta/","image_url":"https://cellcarta.supreme.com/wp-content/uploads/page-builder-assets/placeholder-640x480.png","image_alt":"Biomarker assay NSCLC CTA poster"},{"card_type":"Poster","date":"April 14,2026","reading_time":"","title":"Emerging Biomarkers Shaping the Next Generation of ADC Therapies","description":"","url":"https://cellcarta.com/science-hub/emerging-biomarkers-shaping-the-next-generation-of-adc-therapies/","image_url":"https://cellcarta.supreme.com/wp-content/uploads/page-builder-assets/placeholder-640x480.png","image_alt":"ADC therapies biomarkers poster"},{"card_type":"Poster","date":"April 14,2026","reading_time":"","title":"Fit-for-purpose validation and inter-laboratory cross-validation of a TBNK flow cytometry assay with improved B cell monitoring capabilities","description":"","url":"https://cellcarta.com/science-hub/wrib2026-cross-validation-tbnk-flow-assay/","image_url":"https://cellcarta.supreme.com/wp-content/uploads/page-builder-assets/placeholder-640x480.png","image_alt":"TBNK flow cytometry assay validation poster"}]}#-supreme-cellcarta-overview-3-742{stats-data:[{"number":"5400+","label":"Studies supported"},{"number":"25+","label":"Years of biomarker expertise"},{"number":"750+","label":"Employees"}]}#-supreme-cellcarta-service-blocks-5-742{blocks-data:[{"image":"https://cellcarta.com/wp-content/uploads/2026/06/Genomics-Category-hero-449.jpg","image_alt":"Genomics laboratory","title":"Genomics","description":"Proven and emerging molecular platforms for clinical sample analysis and reporting.","button_text":"Genomic Services","button_url":"/capabilities/genomics/","button_target":"_self"},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/Histopathology-Services-hero-34.jpg","image_alt":"Histopathology slide review","title":"Histopathology","description":"Multiplexed tissue analysis with in-house pathologists and AI-powered image analysis.","button_text":"Histopathology Services","button_url":"/capabilities/histopathology/","button_target":"_self"},{"image":"https://cellcarta.com/wp-content/uploads/2026/08/CellCarta_-50-1-scaled.jpg","image_alt":"Immune monitoring by flow cytometry","title":"Immune Monitoring","description":"Validated immunoassay platforms for precise biomarker quantification and clinical testing.","button_text":"Immune Monitoring Services","button_url":"/capabilities/immune-monitoring/","button_target":"_self"},{"image":"https://cellcarta.com/wp-content/uploads/2026/06/Immunoassay-Services-hero-9.jpg","image_alt":"Immunoassay preparation","title":"Immunoassay Platforms","description":"Validated immunoassay platforms for precise biomarker quantification and clinical testing.","button_text":"Immunoassay Platforms","button_url":"/capabilities/immunoassay-services/","button_target":"_self"},{"image":"https://cellcarta.com/wp-content/uploads/2026/07/CellCarta_-10-2-scaled.jpg","image_alt":"Mass spectrometry proteomic analysis","title":"Proteomics","description":"Fully integrated MS platforms and immunoassays for discovery and bioanalytical testing.","button_text":"Proteomic Services","button_url":"/capabilities/proteomics/","button_target":"_self"}]}