Comprehensive Immuno-Oncology Testing

A Full Suite of Tests for Immunotherapy Biomarkers

Explore More CDx Options with All Currently Available PD-L1 IVDs, Tumor Mutation Burden, MSI, and MMR

NeoGenomics Laboratories is a leader in precision diagnostics and is at the forefront of PD-L1/PD-1 immunotherapy testing. Our broad offering, depth of pathology expertise, and flexible testing options make us an ideal partner for your clinical or research testing needs.

Immuno-Oncology Assays at NeoGenomics

Test Name & Printable Details Ordering Options
NEWTumor Mutation Burden (TMB)
  • Included in NeoTYPE® Discovery Profile
  • Add on to any targeted NeoTYPE Solid Tumor Profile
  • Order as stand-alone test
Microsatellite Instability (MSI)
  • Included in NeoTYPE Colorectal, Endometrial, Esophageal, Gastric, Ovarian, and Pancreas Profiles
  • Add on to any NeoTYPE Solid Tumor Profile
  • Order as stand-alone test
Mismatch Repair (MMR) IHC
  • In panel or individual stains
  • With or without digital imaging
  • Technical-only option for client pathologist sign-out
  • Included in NeoTYPE Solid Tumor Profiles
  • Order as stand-alone test
  • Order as stand-alone test

Advantages of PD-L1 Testing at NeoGenomics

  • Comprehensive PD-L1 testing with all currently available FDA-approved tests in one location
  • Broad experience as one of the first labs to offer PD-L1 testing, having now reported tens of thousands of results
  • Robust reporting and analysis capabilities under the direction of expert pathologists
  • Flexible ordering options with tech-only service for pathology clients who have completed online vendor training
  • Pharma and Research Services  supporting immunotherapy drug development programs and clinical trials including >100 immuno-oncology clinical projects


On-Demand Webinar: PD-L1 Testing in Solid Tumors


PD-L1 IHC Testing for Solid Tumors

PD-L1 testing is an immunohistochemical assay that detects the level and expression sites of PD-L1 protein. As a companion or complementary diagnostic for certain tumors and indications, it helps identify patients for treatments including KEYTRUDA®1, OPDIVO®2, TECENTRIQ®3 and IMFINZI™4.

Testing for Every Current PD-L1 IHC IVD Assay   

  Clone   Indication Manufacturer FDA-Approved Assay Type Therapy
22C3 NSCLC Dako1 Companion Dx KEYTRUDA® (pembrolizumab)
28-8 NSCLC Dako2 Complementary Dx OPDIVO® (nivolumab)
Melanoma Complementary Dx
SP142 Urothelial Carcinoma Ventana3 Complementary Dx TECENTRIQ® (atezolizumab)
NSCLC Complementary Dx
SP263 Urothelial Carcinoma Ventana4   Complementary Dx IMFINZITM (durvalumab)


  1. PD-L1 IHC 22C3 pharmDx [package insert]. Carpinteria, CA: Dako; P03951_04/SK00621-5/2016.10
  2. PDL1 IHC 28-8 pharmDx [package insert]. Carpinteria, CA: Dako; P04163_02/SK00521-5/2016.01
  3. PD-L1 SP142 Assay [package insert]. Tucson, AZ: Ventana Medical Systems, Inc.;1016217US Rev A; 2016-10-21
  4. PD-L1 SP263 Assay [package insert]. Tucson, AZ: Ventana Medical Systems, Inc.; 1014737US Rev A; 2017-04-21