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
| Technologies | Capabilities | Platform |
|---|---|---|
| IHC/ISH |
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| Imaging |
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| Imaging Analysis |
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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:
| Test | Input Requirements | Requirements |
|---|---|---|
| H&E | Minimum of 1 slide cut at 4-5um | Use 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 assay | Minimum of 2 slides cut at 4-5um per marker | Use 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. |
| Total | 2 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