Latest Breast Cancer News

Optiscan Imaging has begun commercial sales of its InSpecta™ microscopic imaging device in the US veterinary sector following FDA clearance, marking its first clinical device launch and a strategic expansion into a $15.87 billion market.

BCAL Diagnostics has locked in an additional $4.9 million under its existing convertible note facility alongside a $1.4 million R&D tax offset tranche, reinforcing its funding runway into FY2027 for early cancer detection test development.

Imagion Biosystems has raised $3.75 million to fund the start of its Phase 1b/2 clinical trial for the MagSense HER2 imaging agent in the US, following FDA clearance. The capital raising involves a two-tranche share placement with free attaching options, led by CPS Capital.

INOVIQ Limited’s CAR-exosome platform demonstrated potent tumour-killing activity in ovarian cancer cell lines, eliminating up to 90% of cancer cells within 48 hours and reinforcing its potential against hard-to-treat solid tumours.

BCAL Diagnostics has developed BREASTEST Monitor, a blood test showing promising accuracy in detecting local breast cancer recurrence in women over 50, aiming to simplify post-treatment monitoring.

Optiscan Imaging has reached the halfway recruitment milestone in its first in-human breast cancer study, advancing its regulatory and commercial ambitions with promising clinical data and expanded trial sites.

ImpediMed has revamped its leadership with two new commercial roles and reported encouraging sales momentum for its SOZO device. The company is advancing clinical trials and expanding its presence in cancer survivorship, weight management, and heart health sectors.

Imagion Biosystems has secured FDA clearance to proceed with its Phase 1b/2 trial of the MagSense® HER2 Imaging Agent, targeting improved detection of HER2+ breast cancer. Patient recruitment is expected to start in Q3 2026, marking a crucial step toward commercialisation.

BCAL Diagnostics appoints Anne-Louise Arnett as CEO effective June 2026, aiming to accelerate its commercial rollout and international market entry of early cancer detection tests.

Optiscan Imaging has submitted its FDA dossier for InSpecta®, marking a crucial step toward US veterinary market entry, while progressing clinical studies for InVue® and InForm® ahead of further FDA submissions in 2026.

Mayne Pharma’s third quarter results show modest revenue growth but a sharp improvement in cash flow and earnings, powered by the strong launch of DistributeRx and robust Women’s Health sales.

Cleo Diagnostics (ASX:COV) has hit a major milestone by completing sample collection for its pivotal U.S. ovarian cancer trial, while progressing manufacturing and analytical validation steps toward FDA 510(k) submission.