Anatomic Pathology Services

Our vast experience in clinical grade anatomic pathology (AP) services includes comprehensive histology services, a full IHC/CISH menu and image analysis/digital pathology capabilities to support oncology and inflammatory diseases. With decades of experience developing and implementing leading-edge tests to service the pharma, oncology, pathology and research communities our AP services are capable of delivering results for any project scope or intended use.

Our AP services include:

  • Pathology and technology expertise built on decades of experience and industry leadership.
  • Platform-agnostic, customizable manual or digitized qualitative and quantitative assays to support your CDx, clinical trials, or development needs — delivered with rigorous, industry-leading quality standards.
  • Histology (processing, embedding and microtomy), which services many downstream modalities including FISH, MultiOmyx/Polaris and Molecular.
  • Custom IHC/chromogenic in situ hybridization (CISH) development, validation and testing.
  • Expert (and clinically or trial-relevant) pathology evaluation criteria with reportable format-development, incorporating evaluation by a sub-specialized pathology team.
  • >400 validated IHC/CISH stains across our Clinical and Pharma divisions.
  • Multiple platforms for technology agnostic development of optimal stain quality or downstream partnering with an in vitro diagnostics (IVD) partner of choice.
  • High-quality, tailored solutions for a wide range of quantitative image analysis requirements.

AP Technologies

Capabilities and Platforms

TechnologiesCapabilitiesPlatform
IHC/ISH
  • 2,500 IHC/ISH stains per day (in antivirus (US) testing)
  • 400 validated IHC assays (in AV testing)
  • Laboratory developed test (LDT), IVD, clinical trial assay (CTA) and CDx options Ventana Benchmark ULTRA
  • Dako Link 48
  • Dako Omnis
  • Leica BOND-III/BOND RX
  • Ventana Benchmark ULTRA
Imaging
  • Brightfield
  • Aperio ScanScope AT
Imaging Analysis
  • Cell morphology & cell count
  • Dot count (ISH)
  • Whole specimen analysis
  • Pattern recognition and tissue discrimination
  • AI implementation
  • Fully customizable
  • Indica HALO
  • Visiopharm


Applications and Capabilities 

  • Histology supports AP, FISH, Molecular and Multiplex modalities.
  • Custom development and validation of novel biomarkers, fit for purpose and designed to evolve with your program.
  • Assay transfer, assay development, technical/exploratory test development, validation, enrollment/screening and investigational use only (IUO) > CDx test development.
  • Trial testing: disease diagnosis, prognosis and confirmation; specific biomarker screening; tumor profiling.
  • From single-plex IHC/CISH assays to supporting multiplex development.
  • Qualitative and quantitative scoring and image analysis.
  • Tissue microarray (TMA) screening (prevalence).

See brochure for full list of markers and additional information on our services on:

  • Standard LDT/CTA
  • IUO/RUO IVD (CDx validation)
  • De novo assay development and validation
  • Assay transfer and validation
  • Validation expansion
  • Technical studies


Specimen requirements for tumor tissue: FFPE tissue: Paraffin block is preferred, slide requirements are listed below.

Tumor Sample Slide requirements per Assay:

TestInput RequirementsRequirements
H&EMinimum of 1 slide cut at 4-5umUse cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
IHC assayMinimum of 2 slides cut at 4-5um per markerUse cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
Total2 IHC Assays + H&E = 5-7 slides*

*Prefer 7 slides, including 2 as backup.
For FFPE blocks: please send block.
For Core Needle Biopsy: 2 - 4 cores at standard gauge core needle biopsy

NeoGenomics Laboratories, Inc.
Attn: Pharma Services
31 Columbia
Aliso Viejo, CA92656
biopharmprocessing@neogenomics.com
Phone: 949-445-7300 x7103
Customer Service: +1-888-248-5275
Email: alisoviejo.biopharmprocessing@neogenomics.com