Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, announced that the U.S. FDA has approved the expansion of the intended use of Dako PD-L1 IHC 28-8 pharmDx to include patients with melanoma.  Dako’s PD-L1 IHC 28-8 pharmDx diagnostic first received approval from the FDA on Oct. 9, 2015, for non-squamous, non-small cell lung cancer (NSCLC). The complementary test has now been expanded to include melanoma and may be used by physicians to determine PD-L1 status. Positive PD-L1 status in melanoma has been correlated with the magnitude of treatment effect on progression-free survival from OPDIVO®(nivolumab), from Bristol-Myers Squibb. These complementary tests are distinct from companion diagnostics, which are essential for safe and effective use of a drug.

Source:

http://www.dako.com/us/index/aboutdako/newsevents/news/dako-announces-expanded-fda-approval-of-complementary-diagnostic-test-to-include-melanoma.htm#.VqngtJorLIU