Laboratory Corporation of America Holdings (LabCorp), the world's leading healthcare diagnostics company, announced the nationwide availability of a new FDA-approved diagnostic test for PD-L1 associated with the expanded approval of Bristol-Myers Squibb Company's (BMS) Opdivo (nivolumab) for the treatment of all appropriate patients with previously-treated non-small cell lung cancer (NSCLC).

The PD-L1 IHC 28-8 pharmDx assay was developed by Dako, an Agilent Technologies company. The assay was used to assess PD-L1 expression in the phase 3 CheckMate 057 trial, in which Opdivo demonstrated superior overall survival compared to chemotherapy in patients with previously treated metastatic non-squamous NSCLC. This approval expands the indication for Opdivo to include previously treated non-squamous NSCLC in addition to the squamous NSCLC indication. The test, although not required for Opdivo, is a new tool that provides physicians with information on the potential survival benefit of treatment with Opdivo.

"The launch of this innovative assay reinforces the importance of the LabCorp-Covance combination," said David P. King, chairman and chief executive officer of LabCorp. "Our central laboratory was the sole provider of testing for PD-L1 expression in the CheckMate-057 trial, which trial was the basis for regulatory approval, and LabCorp is one of the first laboratory providers of the PD-L1 IHC 28-8 pharmDx assay. We remain committed to our three strategic priorities: bringing innovative medicines to patients, using information to change the way care is delivered, and providing world-class diagnostic information."

"LabCorp's support for CheckMate-057, a pivotal phase 3 registration trial evaluating survival benefit compared to chemotherapy, was an important contribution to OPDIVO's clinical development program," said Michael Giordano, senior vice president, head of Development, Oncology, Bristol-Myers Squibb.

"We are very pleased with LabCorp's seamless role supporting clinical development and regulatory approval of this new assay which can provide additional information to physicians."

"LabCorp's support of a variety of BMS clinical trials involving Opdivo gives us experience that no other lab has in performing and interpreting the results of this important complementary diagnostic assay," stated Steve Anderson, chief scientific officer of Covance.

"The availability of this test in support of an important new therapy reflects how our combined capabilities in drug development and diagnostics will support improved patient outcomes and reduced healthcare costs by delivering world class diagnostics and bringing innovative new medicines to patients."

According to the American Cancer Society, lung cancer is the leading cause of cancer death in the US and is the second most commonly diagnosed cancer, with an estimated 221,200 new cases diagnosed in 2015. Approximately 85-90 per cent of patients with lung cancer are diagnosed with either squamous or non-squamous NSCLC, and a majority of these patients present with advanced stage disease at their initial diagnosis.