OREANDA-NEWS. August 21, 2012. Daiichi Sankyo Co., Ltd. announced that it has received approval in Japan for an additional indication for the ultrasound contrast agent, 16µL vials of SONAZOID® for injection, for the imaging of focal breast lesions.

SONAZOID® is an ultrasound contrast agent consisting of microbubbles with increased stability under ultrasound fields, which enables continuous diagnostic scanning with an excellent contrast effect. SONAZOID® was approved for market authorization in Japan, and ahead of other countries, in January 2007 for a focal liver lesion diagnosis indication.

A phase 3 confirmatory study in patients with focal breast lesions demonstrated a superiority of contrast-enhanced ultrasound with SONAZOID® compared to that of unenhanced ultrasound in accuracy of tumor characterization. Moreover, tolerability was also shown. SONAZOID® is expected to serve as a new option for the diagnosis of focal breast lesions and its disease management through its excellent diagnostic performance in differentiating benign and malignant lesions.