Prostate cancer affects roughly 1 in 9 American men in their lifetime, with 174,650 new cases reported each year. However, current prostate specific antigen (PSA) tests lack specificity, leading to overdiagnosis and overtreatment of inconsequential cancers. Cleveland Diagnostics Inc. is looking to change that with its IsoPSA assay, which just received a breakthrough device designation from the U.S. FDA. In clinical studies, the noninvasive, blood-based test has been shown to have higher accuracy than standard PSA tests.

PERTH, Australia – Telix Pharmaceuticals Ltd. raised AU$40 million as it prepares regulatory packages and commercial strategies in Europe, the U.S. and Australia.

Bracco Imaging SpA. is buying prostate cancer imaging specialist Blue Earth Diagnostics Ltd. for $450 million, acquiring full rights to Axumin (F18-fluciclovine), a PET radiocontrast agent originally developed by Chicago-based GE Healthcare.