Quest Diagnostics announced it will offer clinical laboratory testing using the PD-L1 IHC 28-8 pharmDx qualitative test from Dako. Earlier January 25, 2016, Dako announced the U.S. Food and Drug Administration (FDA) approved the complementary in vitro diagnostic test for use in the detection of PD-L1 expression in formalin-fixed, paraffin embedded (FFPE) melanoma tissue. In addition, the FDA approved Bristol-Myers Squibb's OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab) for the treatment of patients with unresectable or metastatic melanoma, regardless of BRAF mutational status.

The approval expands the original indication for the OPDIVO + YERVOY Regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include all patients, regardless of BRAF mutational status. The FDA also expanded the use of OPDIVO as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients. These expanded indications are approved under accelerated approval based on progression-free survival.

Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. The PD-L1 IHC 28-8 pharmDx complementary test is distinct from companion diagnostics, which are essential for safe and effective use of a drug. Biomarker testing is not required for the OPDIVO + YERVOY Regimen or OPDIVO as a single-agent, but it may provide additional information for physicians regarding the use of OPDIVO.

Dako selected Quest Diagnostics to validate and ensure the PD-L1 IHC 28-8 pharmDx test would be widely available to physicians and patients upon FDA approval through qualified lab providers. Quest expects to make the test service available for order in the United States beginning February 1, 2016. This is the third service that Quest Diagnostics has made available based on the Dako PD-L1 test through an expedited process related to FDA approval of an immunotherapy.