Clinical Trial IHC and Pathogy Review

Gnome Sciences provides a comprehensive set of routine and specialized pathology lab services for Clinical Trials. Our precision laboratory research services are performed in our CLIA certified molecular biology and pathology laboratories. We offer top quality and fast turnaround in our labs, managed by board-certified pathologists and experienced laboratory staff, so that we can Analyze, Image, Interpret, and Report your results.

Discuss your clinical trial IHC needs with our scientists:

Service Details:

Gnome Sciences provides a full range of Pathology Services for your clinical trials using retrospectively collected tissue samples. We can participate in any stage(s) of your pathology study. Send us your prepared histologic slides or specimens. We will prepare the slides from your tissue specimens in our CLIA labs under supervision of a board-certified pathologist.

We guarantee expert results across your study whether it is tens, hundreds, thousands or more slides.

Gnome Sciences Clinical Trial Pathology Services include:

Tissue preparation, sectioning and slide preparation

(if needed), optimized for your tissue types and study needs. The Gnome Sciences team has experience with a vast array of tissue types.

Slide Staining:

Gnome Sciences offers a full range of histological staining techniques to help you visualize particular cell structures and elements within your clinical trial tissue specimens. Our pathologists and skilled technicians can guide you toward which stains will present what you need to detect in the best format for your study.

Immunohistochemistry (IHC) staining:

Our pathologists and technicians have decades of experience in IHC techniques to localize antibodies successfully to their specific antigen sites within tissue so you can visualize protein expression at the cellular level within your tissue sections. We utilize a wide range of antibodies and methods and will select and optimize the methods for your study. We use multiple platforms, including Leica and Ventana, and manual formats to get clean, clear signals using diverse chromogen colors.

In Situ Hybridization (ISH/FISH/ RNAScope®):

Gnome Sciences routinely performs ISH to detect, quantify, and localize subcellular DNA and RNA molecules (including microRNA). We can perform co-localization studies to detect co-incidence of biological macromolecules using multi-color chromogenic studies.

Multiplex Chromogenic Staining:

Gnome Sciences combines routine cellular stains with multiple molecular biomarker detection using IHC, ISH to simultaneously analyze multiple proteins or nucleic acids or combinations of the two on single slides (or on immediately adjacent slides for very large numbers of molecular biomarkers).

Antibody Optimization:

The scientists at Gnome Sciences can select and optimize the antibodies for your IHC studies. This includes selection of the right proteins and epitopes for needed specificity in your IHC tissue studies, antibody type (mono- or polyclonal), species, and label. In addition, we can tailor the specimen preparation (fixation and antigen retrieval) for optimal detection of your one or more simultaneous protein biomarkers in the presence of other stains and treatments.

Molecular Biology Analysis:

Gnome Sciences offers a comprehensive set of molecular pathology and molecular biology solutions including nucleic acid isolation, quantifying specific protein and nucleic acid molecules (biomarkers) from tissue samples (total expression levels) and providing genome variant (SNP) analysis of RNA and DNA species in tissues including tumor biopsy regions.

Rapid Genotyping (mutation analysis):

Because of our extensive experience as a high-throughput COVID-19 RT-PCR clinical testing laboratory, we are able to provide clinical grade genotyping (SNP/mutation analysis) results within 24 hours of sample receipt at sufficient sample volumes (for example, minimum of 40 samples per run, up to thousands per day). This may be particularly useful for recruiting patients for clinical trials for rare genetic diseases – where specific genetic markers are indicated for inclusion/exclusion in addition to clinical criteria.

Digital Pathology and Slide Scanning:

Gnome Sciences uses state of the art information systems to ensure quality, regulatory compliance, end-to-end tracking of your samples, analysis of your results, and secure reporting of your data. This includes sample accessioning in our LIMS system, management of SOPS, reagents and protocols, storage and analysis of imaging data, interpretation and reporting of the findings, and delivery of your data and reports. We employ Aperio Digital Pathology Scanners, which scan the whole slide, along with image analysis software, which automates tasks to provide statistically significant results. All of our automated systems are overseen by senior lab staff. You will also receive scans from representative microscopy imaging in your tissue’s Region(s) of Interest. You will get high resolution, publication-ready digital images as well as our board-certified pathologist’s expert interpretation. As projects are completed, we can send you your data digitally (for example, on 64-GB USB thumb drives), or you can securely log in to our custom lab services portal. We can perform staining and/or slide scanning for as many specimens or slides as you need.

Customized Reporting:

In addition to customized reports for your studies and for individual patient biospecimens, we can report results directly into your information systems if you desire, in addition to our own LIMS and reporting system. We will meet your every requirement for reporting, including layout, kinds of data, and what to report. You can tell us, for example, how many images you want for each patient, level of magnification for photomicrographs, desired interpretation and analytics from whole slide imaging, and what kinds of captions and annotations you want on your images. Reporting can differ based on patient diagnosis, as well. All reports are reviewed by board-certified pathologists.

Gnome Sciences Clinical Trials Services may include:

  • Protocol design and development and method validation
  • Advise on method selection
  • Our full range of anatomic and histologic pathology services
  • Molecular characterizations and customized biomarker assays
  • Reference Lab service provider
  • Genetic patient matching for clinical trials and inclusion/exclusion
  • Data management and reporting (using our validated LIMS system, SOPs, etc.)
  • Regular reporting and progress meetings guided by dedicate project manager
  • Courier or other services for prompt pickup of biospecimens (with full chain of custody tracking)
  • Rapid Start-up. Rapid Scale-up. Rapid Delivery
  • CLIA certified lab: processes, standards, controls; quality of research and data.
  • Our Team provides hundreds of years of industry experience.