It’s no surprise to hear that industry’s view of a device’s inherent risk differs from that of the U.S. FDA, a disparity that came to surface in a new citizen petition from Metaltronica SpA of Pomezia, Italy. The company petitioned the agency to down-classify digital breast tomosynthesis system to class II, a move that would align the risk classification with full-field digital mammography and ease the premarket path for future digital breast tomosynthesis applications.

This time a positive result for a cancer screening test brought good news, as Geneoscopy Inc. secured U.S. FDA approval for its RNA screening test for colorectal cancer. The agency based its decision on strong results from the phase III CRC-PREVENT trial in its approval of the noninvasive test for use in individuals aged 45 years and older with average risk for the disease.

Australia is poised to play a leading role in the rise of the global radiopharmaceutical industry, as advanced therapies drive significant investment and rapid expansion, according to a new discussion paper from industry accelerator Mtpconnect.

Angle plc recently signed an agreement with Astrazeneca plc to develop an androgen receptor (AR) detection assay for use in prostate cancer studies, based on its Parsortix system, which captures and harvest circulating tumor cells for subsequent analysis.

Australia is poised to play a leading role in the rise of the global radiopharmaceutical industry, as advanced therapies drive significant investment and rapid expansion, according to a new discussion paper from industry accelerator Mtpconnect.

Quest Diagnostics Inc. and Pathai Inc. established a forward-looking deal with multiple components and room for growth. The collaboration includes Quest’s acquisition of Pathai Diagnostics – the division that provides anatomic and digital pathology laboratory services – and licensing of Pathai’s Aisight digital pathology image management system. The companies also said they may work together on development of Pathai’s algorithm products and that Quest will be a preferred provider for Pathai’s biopharmaceutical clinical laboratory services.

Lindis Blood Care GmbH recently revealed excellent data from the Remove study that showed that its Catuvab device was safe and effective in removing tumor cells from intraoperative blood during high blood loss cancer surgeries.

Hologic Inc. moved to expand its breast surgery line with the acquisition of Endomagnetics Ltd. (Endomag) for a proposed $310 million. Endomag offers a magnetic system that allows precise localization of tumors in the breast and lymph nodes without the use of radioactive materials or wires, enabling greater preservation of healthy tissue. The transaction is expected to close in the second half of 2024.

Sunbird Bio Inc. is advancing its blood-based diagnostics platform for neurological diseases like Alzheimer’s and Parkison’s disease (AD/PD), amidst new breakthroughs in the AD drug therapies and diagnostics space.

Researchers have developed and validated a new technique that allows them to measure the lipid compounds in live cancer cells, one by one, according to a study published in the journal Analytical Chemistry. The new method paves the way for analyzing cells in greater detail to better understand infection, immunity and other phenomena, and could lead to the development of new, more targeted treatments.