Test Code

I PD-L1

Associations

Assessment of PD-L1 expression in non-small cell lung cancer (NSCLC) and other tumor types.

MPLN offers SP263 immunohistochemical testing for the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded tissue.PD-L1 expression level utilizing this clone has been associated with response to durvalumab (IMFINZI, AstraZeneca UK Limited).

Methodology

Immunohistochemistry, Technical component (TC) available
This assay utilizes the VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody (VENTANA PD-L1 (SP263)) which is a rabbit monoclonal primary antibody directed against the programmed deathligand1 (PD-L1) B7 homolog 1 (B7-H1, CD274).  The antibody detects the extracellular domain of PD-L1 and produces membranous and/or cytoplasmic staining.

Turnaround Time

2 days

Specimen Requirements

Paraffin embedded tissue block
3 slides (3-5 uM) per marker on adhesion glass

Specimen Stability

Storage & Handling

Ship ambient. Protect from extreme temperature with an ice pack. Separate ice pack from specimen.

Causes for Rejection

Improper specimen labeling; Insufficient sample; Inadequate fixation and/or processing

Reference Range

Quantitative in Tumor Infiltrating Lymphocytes (TILs): Cut off POSITIVE in =/>25% of tumor infiltrating lymphocytes (TILs); NEGATIVE (no reactivity in tumor infiltrating lymphocytes, <25%)

Description

PD-L1 IHC is indicated as an aid in the assessment of PD-L1 expression in non-small cell lung cancer (NSCLC) and other tumor types.  PD-L1 is a critical immune regulatory molecule which can be expressed by tumor cells as a mechanism to escape immune surveillance.  Assessment of tumor PD-L1 protein levels may have prognostic and/or therapeutic significance in some cancer patients.  Identifying PD-L1 expression on tumor cells may help determine which patients will most benefit from anti-PD-1/PD-L1 therapy.

References

Read more about PD-L1 testing at MPLN here

1. Marlon Rebelatto et al. 2015. Development of a PD-L1 companion diagnostic assay for treatment with MEDI4736 in NSCLC and SCCHN patients. J Clin Oncol 33, 2015 (suppl; abstr 8033).
2. Naiyer Rizvi et al. 2015. Tumor response from durvalumab (MEDI4736) + tremelimumab treatment in patients with advanced non-small cell lung cancer (NSCLC) is observed regardless of PD-L1 status. Journal for ImmunoTherapy of Cancer 3(Suppl 2):P193.