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FDA Grants Breakthrough Device Status to Elecsys GALAD Score for HCC

Gina Columbus @ginacolumbusonc
Published: Wednesday, Mar 04, 2020

Amit Singal, MD, medical director of the Liver Tumor Program, and clinical chief of Pathology at UT Southwestern Medical Center

Amit Singal, MD

The FDA has granted a breakthrough device designation to the Elecsys GALAD score, an algorithmic score designed to aid in the diagnosis of early-stage hepatocellular carcinoma (HCC).

 

References

  1. FDA grants breakthrough device designation for Roche's Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma [news release]: Basel, Switzerland. Roche. Published March 4, 2020. https://bit.ly/2PLLY5H. Accessed March 4, 2020.
  2. Zhu AX, Kang Y-K, Yen C-J, et al. REACH-2: a randomized, double-blind, placebo-controlled phase 3 study of ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP) following first-line sorafenib. J Clin Oncol. 2018;36 (suppl; abstr 4003). doi: 10.1200/JCO.2018.36.15_suppl.4003
  3. Zhu AX, Ryoo B-Y, Yen C-J, et al. Ramucirumab (RAM) as second-line treatment in patients (pts) with advanced hepatocellular carcinoma (HCC): analysis of patients with elevated α-fetoprotein (AFP) from the randomized phase III REACH study. J Clin Oncol. 2015;33(suppl_3; abstr 232). doi: 10.1200/jco.2015.33.3_suppl.232
  4. Zhu AX, Park JO, Ryoo B-Y, et al. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2015; 16(7):859-870. doi: 10.1016/S1470-2045(15)00050-9

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