PD-L1 by IHC, (TecentriqTM) Urothelial Cancer

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PD-L1 by IHC, (TecentriqTM) Urothelial Cancer

Programmed death 1 (PD-1) is an immune inhibitory receptor expressed on the surface of activated T-cells and mediates suppression of the immune system. PD-1 interacts with the immunosuppressive PD-L1 ligand which is expressed on tumor cells, inflammatory cells, and histiocytes, and inhibits T-cell activation.  A new class of immunotherapies, PD-1 and PD-L1 inhibitors, blocks the interaction between PD-1 and PD-L1 on the tumor cells and can enhance T-cell responses and mediate anti-tumor activity.1

Methodology

Immunohistochemistry (IHC)

Turnaround Time

2-3 days

CPT

Call Client Services

Disease

Bladder Cancer

Specimen

Formalin-fixed, paraffin-embedded tissue block or slides

Volume

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.

Collection

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.  

Special Instructions

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 

Storage Instructions

Room temperature

Use Statement

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

Synonyms

atezolizumab, Programmed Death Ligand 1

References

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.

CPT Codes

The CPT codes included in this publication are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are provided here for the convenience of our clients; however, correct coding often varies from one carrier to another, and LabCorp may bill specific carriers using codes other than those shown. Clients who bill for services should verify the code(s) with the applicable payor to confirm that their use is appropriate in each case.

Profile Policy

LabCorp's policy is to provide physicians, in each instance, with the flexibility to choose appropriate tests to assure that the convenience of ordering test combinations/profiles does not prevent physicians who wish to order a test combination/profile from making deliberate informed decisions regarding which tests are medically necessary. All the tests offered in test combinations/profiles may be ordered individually using the LabCorp test request form.

Please remember that (1) when ordering tests for which Medicare or Medicaid reimbursement is sought, the physician should only order those tests that the physician believes are medically necessary for each patient, (2) that using a customized profile may result in ordering tests for which Medicare or Medicaid will deny payment, (3) that the physician should only order individual tests or a less inclusive profile where not all the tests in the customized test combination/profile are medically necessary for an individual patient, and (4) that the United States Department of Health and Human Services, Office of Inspector General, takes the position that a physician who orders medically unnecessary tests may be subject to civil penalties.

LabCorp encourages clients to contact their local LabCorp representative or LabCorp location if the testing configurations shown here do not meet individual needs for any reason, or if some other combination of procedures is desired.

Investigational Procedures

Some of the individual tests and profile test components listed in this Directory may be considered by Medicare or other insurance carriers as investigational procedures, and therefore, the test may not be payable by the carrier as a covered benefit for the patient. Medicare patients must be informed of this possibility when the physician orders tests that may fall into this category. Affected patients must be asked to sign an Advance Beneficiary Notice, agreeing to be financially responsible if the service is denied by the carrier. Additionally, for other insurance plans, physicians should inform the patient that the service(s) may not be covered by their private insurance plan and, if so, they will be financially responsible for payment. If the patient declines to accept financial responsibility, please do not order the test(s).

As with all clinical assays, results of these tests should be used only in conjunction with other medically established diagnostic elements (eg, symptoms, history, clinical impressions, results from other tests, etc). Physicians should use all the information available to them to diagnose and determine appropriate treatment for their patients. In order to obtain a current list of the procedures that may be considered investigational by Medicare or other insurance carriers, please contact your local LabCorp representative.