A new approach to oncology research

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.

Cerba Research offers 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, 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.

With 25 years of extensive expertise in Flow Cytometry (FCM), Cerba Research offers customized panel design, development, and validation for hematological malignancies and cell & 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. Our FCM laboratories are strategically located in New York, Ghent, Shanghai, Taipei, and Sydney, ensuring global accessibility with harmonized protocols.

Cerba Research provides Minimal Residual Disease (MRD) detection through multiple complementary technologies. We offer flow cytometry-based MRD detection following Euroflow protocols for hematological malignancies, particularly in multiple myeloma studies. While NGS- based MRD detection represents an emerging area in our testing portfolio, we have the technical capabilities to develop and implement these advanced assays. Our scientific team can work with you to design the optimal MRD detection approach for your specific study needs, utilizing our expertise in both traditional and innovative detection methods to support your clinical endpoints.

Cerba Research has conducted approximately 170 oncology trials since 2018, with a balanced portfolio across solid tumors (55%) and hematological malignancies (45%). Our work has contributed to 28 market authorizations and expansions, including 4 approved Cell and Gene Therapies (CGTs) and 6 Immuno-Oncology products. We’ve supported clinical trials across all phases, with particularly strong experience in Phase I and II studies. Nearly 75% of our oncology trials include specialty testing services, and we’ve processed samples from over 26,800 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.

Cerba Research offers the Cerba OncoSign ctDNA panel (50 genes) designed specifically for liquid biopsy applications in solid tumors. This circulating tumor DNA panel enables non-invasive genomic profiling, allowing detection of driver mutations, monitoring of treatment response, and identification of resistance mechanisms through a simple blood draw. Our ctDNA capabilities can be used for various applications including treatment selection, detecting minimal residual disease, and longitudinal monitoring of tumor evolution. We can customize our ctDNA approach based on your specific study needs, with options to develop new panels or add genes to existing panels to target specific biomarkers of interest for your trial.

Cerba Research maintains 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. Specifically, 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.