Plus   Neg

Roche: FDA Grants Breakthrough Device Designation To GALAD Score - Quick Facts

Roche (RHHBY) said the U.S. FDA has granted Breakthrough Device Designation to the Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma. The GALAD score is a serum biomarker-based model that predicts the probability of having hepatocellular carcinoma in patients with chronic liver disease. Combined with ultrasound, the Elecsys GALAD score is minimally invasive to patients, and has the potential to support clinicians by giving them more accurate information at an earlier stage, Roche said.

The Elecsys GALAD score will be the first GALAD score, with regulatory approval, for use in In Vitro Diagnostics and is an integral part of the Roche Diagnostics Liver Indication Program.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Beginning July 6, Google plans to reopen offices in more cities, which were closed following the coronavirus pandemic-related lockdowns across the globe, Chief Executive Officer Sundar Pichai told employees in an email. However, the search giant still expects and encourages most Googlers to largely work from home for the rest of 2020. For those working from home, the company offered an allowance. Bristol Myers Squibb (BMY) announced Wednesday that the European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. With the EC marketing authorization,... Off-price retailer Tuesday Morning Corp. (TUES) on Wednesday filed voluntary petitions for protection under Chapter 11 of the Bankruptcy Code in the U. S. Bankruptcy Court for the Northern District of Texas, Dallas Division. It plans to emerge as a stronger company by early fall 2020. The company...
Follow RTT