iCura Diagnostics


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Diagnostic Laboratory Services for Clinical Trials and Translational Research

iCura Diagnostics provides histology, digital pathology, genomics, CTC, flow cytometry, and other solutions for clinical trials and translational research.


107 Great Valley Pkwy,
Malvern, PA 19355,
United States of America

iCura Diagnostics is a leading contract research organization (CRO) and clinical diagnostics laboratory based in the suburbs of Philadelphia, Pennsylvania. We provide innovative diagnostic solutions designed to meet the needs of the pharmaceutical industry, academic research centers, and partner CROs and laboratories.

At iCura, we specialize in meeting essential demands in precision medicine, immunotherapy, cell and gene therapy, spatial biology, liquid biopsy, and other cutting-edge technologies and platforms. Our comprehensive test menu is thoughtfully designed to meet the essential demands of the research and clinical communities.

Our laboratory holds certification of High Complexity Testing from Clinical Laboratory Improvement Amendments (CLIA) and accreditation from College of American Pathologists (CAP).

Histology and pathology services for patient diagnosis

iCura’s state-of-the-art laboratory offers an extensive range of histology and pathology services, including regular histology, Hematoxylin and Eosin (H&E) stains, Special stains, immunohistochemistry (IHC), multiplex immunohistochemistry (mIHC), immunofluorescence (mIF), digital pathology, Artificial Intelligence (AI) empowered pathology image analysis, and other advanced histology and tissue-level analysis tests. These critical assays play a pivotal role in patient screening and assessing treatment efficacy in immunotherapy translational studies and clinical trials.

iCura provides full scope of histopathology services, including digital pathology offerings such as whole slide imaging, remote sharing and collaboration, quantitative image analysis, etc. There are board-certified pathologists on the team to provide expert diagnostics.
Immunohistochemistry (IHC) is a crucial laboratory technology that involves high level of complexity. It is important to understand all the variables when developing and validating IHC assays to provide accurate information in precision medicine, such as patient screening and/or developing companion diagnostics.
Multiplex immunofluorescence is an emerging technology showing tremendous potentials in spatial biology and precision medicine. Multiple applications have been developed in iCura lab for characterization of tumor microenvironment or confirming difficult diagnosis. It is extremely useful in immunotherapy as well as cell and gene therapy studies.
Multiplex immunofluorescence technology is pivotal in studying tumor interactions with human innate immune systems. This figure shows the spatial relationships between immune cells (such as T cells and macrophages) and epithelial cells/carcinoma. With computer and artificial intelligence (AI) assisted quantitative analysis of these data, iCura can provide critical helps in your precious clinical trials or translational research.
iCura provides high quality quantitative PCR services. Moreover, we’ve invested in platform of Digital PCR – an emerging technology that is quickly adopted by the genomics research community. It provides even higher sensitivity and specificity, as well as more precise quantitative data than qPCR. It is more capable of detecting lower copies of starting material and is suitable for liquid biopsy studies.
NGS sequencing is a powerful tool for large scale genomics analysis. iCura lab provides high throughput NGS sequencing services based on the newest models from Illumina. Image licensed to iCura Diagnostics from CI Photos / Shutterstock.
T cells have proven highly effective at attacking cancer cells. Credit: Sebastian Kaulitzki via Shutterstock.
Human Organoid culturing technology is another novel tool for fast and cost-efficient drug screening. iCura is proud to provide this newly established service line to our clients. Image licensed to iCura Diagnostics from Meletios Verras / Shutterstock.
iCura lab also provides other important services in drug discovery and translational research, such as flow cytometry, biomarker detection, immunoassay, etc. Image licensed to iCura Diagnostics from PowerUp / Shutterstock.
iCura Diagnostics laboratory is fully accredited by CLIA and CAP. We have a strong team of board-certified pathologists, PhD scientists, and highly experienced laboratory professionals. As a central laboratory, we also provide clinical trial logistics, kitting, and regulatory compliance consultation services to our clients. We prioritize on flexibility, agility, and most importantly, the quality of our services. Image licensed to iCura Diagnostics from Matej Kastelic / Shutterstock.

Our expertise extends to assay feasibility studies, method development, and assay validation. We use emerging tools such as mIHC/mIF for spatial biology/phenotyping studies, which enable deeper understanding of the tumor microenvironment and facilitate diagnosis on limited sample materials. With a strong focus on continuous innovation, we have developed and validated multiple panels for immune cell infiltration in solid tumors, disease confirmation panels on lymphomas, and special panels examining the evolution of tumor cell protein expression profiles.

Quantitative image analysis for studying solid tumors

At iCura, we understand the significance of quantitative analysis in driving research outcomes. Our image analysis capabilities enable precise measurements not only for IHC marker quantification/scoring, but also for comprehensive tumor microenvironment and spatial biology studies. Client and collaborators can seamlessly share digital whole-slide images through our remote sharing platform, enabling real-time collaboration and increasing the benefits of digital pathology.

We take pride in our team of board-certified pathologists, whose specialties include solid tumor, hematopathology, cytopathology, and molecular pathology. They provide invaluable central review services to our pharmaceutical clients and diagnostic services to our clinicians and patients and play a vital role in supervising and directing the laboratory’s scientific advancements and regulatory compliance.

Comprehensive genomic solutions to detect tumors

In addition to our histology and pathology services, iCura offers comprehensive genomic solutions utilizing state-of-the-art platforms such as Illumina NGS, QIAcuity digital PCR, quantitative PCR, and conventional PCR. Our genomic services encompass a wide range of sample types, including formalin-fixed paraffin-embedded (FFPE) tissue, frozen tissue, fresh tissue, buccal swabs, nasal swabs, saliva, whole blood, plasma, and other body fluids. Our fully automated workflow ensures the accuracy and consistency of all our tests.

With our focus on oncology specimens, we offer distinct panels designed to detect solid tumours and haematologic malignancies. In addition, we offer in-demand microbiological and viral testing, including highly sought-after services such as rAAV assays, Redsidual DNA quantification assays, Rapid Bioburden Assays for cell and gene therapy, and waste water surveillance and viral copy number assays. We work with experts in circulating tumour cell (CTC) isolation and enumeration, conducting protein and genomic level characterization of CTCs.

Organoid culture tools to improve testing and screening

One of iCura’s recent advancements is the establishment of human organoid culture systems, facilitating and significantly enhancing drug discovery processes. With tumor organoid culture tools at our disposal, pharmaceutical companies or researchers can now easily test and screen drug or compound responses in environments that closely resemble human in vivo conditions, eliminating the need for costly and burdensome animal studies.

Alongside our biomarker testing capabilities, we offer cytokine detection on Meso Scale Discovery (MSD) platforms, antibody detection on ELISA assays, and a team of dedicated flow cytometry specialists.

Regulatory compliance checks for life science facilities

At iCura, we understand the importance of regulatory compliance in the field of clinical laboratory testing. Beyond our laboratory services, we support clients with laboratory accreditation and compliance issues. We have a proven track record of assisting our clients in developing and validating their laboratory environments and specific assays as laboratory-developed tests (LDTs).

We are proud to offer comprehensive consultations from our team of highly qualified, board-certified pathologists and laboratory professionals. Whether you are seeking accreditation from major regulatory agencies or need assistance with test validation to meet stringent requirements, our team will provide the necessary guidance and information to ensure your laboratory is fully compliant.

Products and services for central laboratory management

In addition to our core offerings, iCura provides central lab services such as sample administration, storage, and logistics. We offer comprehensive lab manuals, on-site training, sample monitoring, and kitting services to ensure streamlined and efficient sample transportation processes. All the necessary kitting materials for experiments performed in our laboratory are provided, ensuring a hassle-free experience for our clients.

At iCura Diagnostics, we are proud to boast a formidable team of marketing directors, PhD scientists, and experienced laboratory professionals. We prioritize flexibility, adaptability, and the highest quality of services to meet our clients’ unique needs.

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107 Great Valley Pkwy
Malvern, PA 19355
United States of America