Advancing Your Oncology Breakthroughs with Precision and Scale

The right oncology partner combines proven experience across solid tumor and hematological indications, a validated portfolio of biomarker assays (IHC, NGS, ctDNA, flow cytometry, spatial biology), board-certified pathology expertise, harmonized global labs with consistent SOPs, regulatory experience across FDA, EMA, and IVDR, and early scientific engagement at the protocol design stage. Sponsors should specifically ask about turnaround times for time-sensitive endpoints, capacity to scale across regions, integration between specialty and routine testing, and the partner’s track record on similar mechanisms of action.

The Cerba OncoSign 600+ is our comprehensive genomic profiling panel that analyzes 638 genes associated with cancer. This broad-panel next-generation sequencing (NGS) assay is designed to unlock critical genomic information from your specimens, enabling detection of rare and actionable driver mutations. The OncoSign 600+ can determine tumor mutational burden (TMB), microsatellite instability (MSI), and homologous recombinant deficiency (HRD) status, providing valuable insights for patient stratification and therapeutic targeting. This advanced panel is particularly valuable for identifying biomarkers that may predict response to targeted therapies and immunotherapies.

We offer extensive IHC and histopathology services through our global laboratory network, with over 250 validated biomarkers available for human tissues. Our capabilities include IHC simplex and multiplex protocols, fluorescence in situ hybridization (FISH), and various staining techniques. We provide comprehensive tumor-specific testing across multiple cancer types, including lung, breast, colorectal, and others. Our histopathology services feature an integrated process with digital pathology, an international network of board-certified pathologists, advanced image analysis using Halo® and Visiopharm® software, and AI-assisted quantification tools. We have particular expertise in PD-L1, HER2, ER/PR, and other critical cancer biomarkers.

View our full list of our biomarkers

With over 25 years of expertise in flow cytometry, we offer customized panel design, development, and validation for hematological malignancies and cell and gene therapy (CGT) studies. Our services include monitoring immunophenotyping, immune cell activation, drug receptor occupancy, and CAR-T cell functionality across blood samples, bone marrow aspirates, and cryopreserved PBMCs. We have specialized experience with multiple myeloma phenotypic assays, CAR-T enumeration for secondary endpoint assessment, and impurity panels to check CAR-T expression on non-T cells. 

We unlock additional value through our partnership with Ozette Technologies, combining integrated spectral flow cytometry and cloud-native AI-enabled analytics to deliver scalable, standardized immune insights that de-risk drug development and accelerate translational and clinical research.

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We have conducted more than 360 oncology trials, with a balanced portfolio across solid tumors (73%) and hematological malignancies (27%). Our work has contributed to 32 market authorizations and expansions, including three approved cell and gene therapies (CGTs). We’ve supported clinical trials across all phases, with particularly strong experience in phase I and II studies. More than 80% of our oncology trials include specialty testing services, and we’ve processed samples from over 35,000 screened patients. Our experience spans multiple indications, including relapsed or refractory multiple myeloma, metastatic breast cancer, neuroblastoma, non-small cell lung cancer, and many others.

We maintain the highest regulatory standards across our global laboratory network. Our facilities hold various accreditations, including CAP/CLIA (College of American Pathologists/Clinical Laboratory Improvement Amendments) in our US locations, with our New York laboratory also having New York State Department of Health certification. Our European facilities are ISO 15189/17025 accredited, while our Asia-Pacific laboratories maintain both ISO accreditations and CAP certification. Our flow cytometry hub in New York is CAP/CLIA accredited; our Ghent facility holds ISO 15189 (BELAC) and CAP/CLIA certifications; our Shanghai laboratory maintains ISO 15189 (CNAS) and CAP accreditations; and our Taipei location is CAP certified. These comprehensive accreditations ensure our facilities meet stringent quality standards for clinical trial testing.

View our full list of certificates and accreditations

Flow cytometry profiles circulating immune cell populations and tracks pharmacodynamic responses; IHC and multiplex IHC characterize the tumor microenvironment, including immune infiltrate density and spatial relationships; NGS identifies tumor mutational burden and immune-related gene expression signatures. Used together, these technologies support patient selection, mechanism-of-action evidence, and resistance characterization. Cerba Research operates all three in harmonized workflows across our oncology Centers of Excellence.