PD-L1 and PD-1 IHC Testing for Solid Tumors

Comprehensive PD-L1 Menu for Clinical Testing and Pharma Research

NeoGenomics Laboratories is a leader in precision diagnostics and is at the forefront of PD-L1/PD-1 immunotherapy testing. PD-L1 testing is an immunohistochemical assay that detects the level and expression sites of PD-L1 protein. As a companion/complementary diagnostic for certain tumors and indications, it helps identify patients for treatments such as KEYTRUDA®1, OPDIVO®2, and TECENTRIQ®3. Our broad offering, depth of pathology expertise and experience in immuno-oncology testing make us an ideal partner for your clinical or research testing needs.

  • Experience – One of the first labs to offer PD-L1 testing
  • Expertise – Reported thousands of PD-L1 results
  • Clinical Trials – Supports over 100 immuno-oncology clinical projects

Advantages of PD-L1 Testing at NeoGenomics

  • Comprehensive clinical grade PD-L1 testing in one central location
  • Accurate and sensitive detection of PD-L1 expression
  • Robust reporting and analysis capabilities under the direction of expert pathologists
  • Pharma and Research Services to support immunotherapy drug development programs
  • Flexible ordering options and fast TATs

Ordering Options

PD-L1 IHC and PD-1 IHC can be ordered as stand-alone tests or in any combination with other IHC, FISH, or molecular tests offered. PD-L1 22C3 pharmDx IHC is also a standard component of solid tumor NeoTYPE™ Cancer Profiles, which offer multimethod analyses of broad or tumor-specific biomarker profiles.

February 2017: PD-L1 22C3 pharmDx IHC replaces LDT, Tech-Only Training is Required

Effective the week of February 6, NeoGenomics is replacing the PD-L1 IHC lab-developed test (LDT) with the PD-L1 22C3 pharmDx test. For non-small cell lung cancer (NSCLC) patients, this change enables FDA-approved PD-L1 testing to identify patients for treatment with Keytruda®1. PD-L1 22C3 results will be provided for other tissue types, and this testing is considered off-label. Tech-only clients who wish to sign out cases with 22C3 must complete online training from the test vendor, Agilent/Dako.
Please see our Client Notice with further information about the change and training.

PD-L1 Assays Available at NeoGenomics

Manufacturer

  Clone  

Indication

FDA-Approved Assay Type

Therapy

Dako1 22C3 NSCLC Companion Dx KEYTRUDA® (pembrolizumab)
Dako2 28-8 NSCLC Complementary Dx OPDIVO® (nivolumab)
Melanoma Complementary Dx
Ventana3 SP142 Urothelial Carcinoma Complementary Dx TECENTRIQ® (atezolizumab)
NSCLC Complementary Dx

 

Dr. Albitar on PD-L1 Tests with Molecular Testing

Watch Dr. Albitar’s Comparison of PD-L1 Companion,
Complementary and Laboratory Developed Tests with Molecular Profiling.

Learn More

References 
  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]. Tuscon, AZ: Ventana Medical Systems, Inc.;1016217US Rev A; 2016-10-21