Actionable news
0
All posts from Actionable news
Actionable news in LH: LABORATORY CORPORATION OF AMERICA HOLDINGS,

Laboratory Corporation of America: 358 South Main Street

The following excerpt is from the company's SEC filing.

Burlington, NC 27215

Telephone: (336) 584-5171

LabCorp to Offer New PD-L1 Test for Bristol-Myers Squibb’s OPDIVO

Following Collaboration in Clinical Trial

Test Launch Demonstrates that Combined LabCorp-Covance Capabilities Provide Best in Class Solutions for Development and Commercialization of Diagnostics Linked to Innovative Medicines

Laboratory Corporation of America

Holdings (LabCorp

) (NYSE: LH) today announced the nationwide availability of a new FDA-approved diagnostic test for PD-L1 associated with the expand ed 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...


More