Funding and Leadership Risks Loom as BCAL Expands US Operations

A Landmark Launch in Breast Cancer Diagnostics

BCAL Diagnostics Limited has taken a significant step forward with the commercial launch of BREASTESTplus™, a novel lipid-based blood test designed to improve early breast cancer detection, particularly for women with dense breast tissue. Introduced in April 2025 at the Sydney Breast Clinic, the test is now accessible across eight clinics and supported by 93 pathology sites, engaging 33 breast cancer specialists. This launch represents the culmination of years of development and validation, positioning BCAL at the forefront of diagnostic innovation in a challenging clinical area.

Financials Reflect Investment in Growth

For the fiscal year ending June 30, 2025, BCAL reported a net loss of $7.24 million, a 13% increase from the previous year’s $6.4 million loss. This widening deficit is largely attributable to intensified research and development efforts and the costs associated with commercializing BREASTESTplus™. Despite the loss, the company secured $4.3 million through capital raising and ended the year with a cash balance of $4.5 million, bolstered by a $2.5 million R&D tax offset. These funds underpin ongoing market expansion and product development initiatives.

Expanding Footprint and Clinical Validation

BCAL’s strategic expansion includes the establishment of a wholly owned US subsidiary in North Carolina, enhancing its research and development capabilities and facilitating patient recruitment for clinical studies. The US market is a key target for future growth, with clinical trials underway at multiple sites. Back home, BCAL has forged partnerships with Cancer Care Associates and, more recently, Sonic Healthcare Australia, enabling broader access to BREASTESTplus™ through 93 pathology centers in Sydney. These collaborations are critical to integrating the test into routine clinical workflows and accelerating adoption among specialists and general practitioners.

Intellectual Property and Scientific Validation

BCAL continues to strengthen its intellectual property portfolio, securing its third Australian patent and filing applications across major international markets including the US, Canada, Japan, China, and Europe. The company’s proprietary lipidomic technology, which underpins BREASTESTplus™, was recently featured in a peer-reviewed publication in the International Journal of Molecular Sciences, providing scientific validation that supports clinical uptake.

Governance and Leadership Changes

Post-year-end, BCAL experienced notable board changes with the resignations of co-founder Ronald Phillips AO and director Mark Burrows AO. These departures mark the end of significant tenures and may influence the company’s strategic direction. Meanwhile, the executive team, led by Executive Chair Jayne Shaw and CEO Shane Ryan, remains focused on scaling commercial operations and advancing the product pipeline.