Biotech FDA Update: Agilent Technologies Inc (NYSE:A), Tocca Life Holdings Inc (OTCMKTS:TLIF), Endologix, Inc. (NASDAQ:ELGX)
Agilent Technologies Inc (NYSE:A)
Dako, an Agilent Technologies Inc (NYSE:A) company and a worldwide provider of cancer diagnostics, announced Oct. 9 that the U.S. Food and Drug Administration has approved a new test that can identify PD-L1 expression levels on the surface of non-small cell lung cancer tumor cells and provide information on the survival benefit with OPDIVO(R) (nivolumab) for patients with non-squamous NSCLC.
Tocca Life Holdings Inc (OTCMKTS:TLIF)
TOCCA Life Holdings, Inc. (OTC PINK: TLIF) announced today that it is filing an application for FDA approval for the first of its products, “TOCCA Screen.” TOCCA Screen is expected to be the most comprehensive home drug test kit currently available.
With 1 out of 4 families in America affected by the disease of addiction, TOCCA’s bio technology focus on clinical laboratory toxicology and home based sobriety products used for early detection, is a key component of in its objective of creating accountability in the home and in the workplace.
Endologix, Inc. (NASDAQ:ELGX)
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that it has received U.S. Food and Drug Administration (FDA) approval for the AFX®2 Bifurcated Endograft System for the treatment of abdominal aortic aneurysms (AAA). This new device is the latest innovation in the AFX Endovascular AAA family of products. Endologix plans to highlight AFX2 at the 2015 VEITH symposium taking place November 17-21 in New York City, with a commercial launch in the U.S. expected to begin in the first quarter of 2016.
AFX2 reduces procedure steps for the delivery and deployment of the bifurcated endograft. The new device also facilitates percutaneous EVAR by providing the industry’s lowest profile contralateral access through a 7F introducer. These improvements bring together Endologix’s ActiveSeal™ technology, DuraPly™ ePTFE graft material and VELA™ Proximal Endograft, into an integrated new EVAR (endovascular aneurysm repair) system.
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