Call Client Services
Formalin-fixed, paraffin-embedded tissue block or slides
One formalin-fixed, paraffin-embedded (FFPE) tissue block or four unstained positively charged slides sectioned from FFPE tissue block at 4 to 5 microns and be less than 2 months after sectioning if stored at 15-30°C.
Recommended handling and processing conditions are: Recommended fixative is 10% neutral buffered formalin for a fixative time of at least 6 hours. Fixative times less than 6 hours results in a significant loss of staining intensity. Other fixatives are not recommended.
Pertinent clinical diagnosis, including a pathology report, should be included with the specimen.
Causes for Rejection
Insufficient tissue; inappropriate tissue source; incorrect specimen type; tumor other than urothelial/bladder cancer
An ongoing Phase II clinical trial (IMvigor 210 trial) has shown that patients' tumor PD-L1 IHC expression levels correlated with overall response rates with the therapy TECENTRIQ (atezolizumab) and that the response was durable. The FDA recently approved the VENTANA anti-PD-L1 (SP142) IHC assay as a complementary diagnostic assay that may help identify patients with locally advanced or metastatic urothelial carcinoma more likely to respond to treatment with Tecentriq (atezolizumab). 2,3
atezolizumab, Programmed Death Ligand 1
1. Kim, JW and Eder, JP, Prospects for Targeting PD-1 and PD-L1 in Various Tumor Types. Available on the website of the Cancer Network. (http://www.cancernetwork.com/oncology-journal/prospects-targeting-pd-1-and-pd-l1-various-tumor-types). Accessed July 8, 2015.
2. Hoffman-Censits, JH et al., IMvigor 210, a phase II trial of atezolizumab (MPDL3280A) in platinumtreated locally advanced or metastatic urothelial carcinoma (mUC). J Clin Oncol 34, 2016 (suppl2S; abstr 355).
3. Genitourinary Cancers Symposium Daily News. IMvigor 210: Atezolizumab Offers Potential of Durable mUC Suppression After Failure of Platinum-Based Treatment. Website http://gucasym.org/daily-news/imvigor-210-atezolizumab-offers-potential-durable-muc-suppression-after-failure-platinum . Accessed 4/11/2016.