BCAL Diagnostics (ASX:BDX) has taken a step toward bringing its flagship blood test to the United States by signing a Validation Agreement with Sonic Healthcare USA.
The agreement calls for BreastestPlus Version 2 to be transferred to Sonic’s CLIA-certified Sonic Reference Laboratory in Austin, Texas, where the assay will be optimised and validated for the US market.
The move follows BCAL’s aim to establish BreastestPlus Version 2 as a Laboratory Developed Test in the US, a pathway the company describes as the fastest and most efficient route for US market entry.
The US breast cancer diagnostics market is large and growing, with more than 40 million mammograms performed annually and roughly 376,000 new breast cancer cases each year. BCAL said successful validation at Sonic’s facility would represent a key milestone on that pathway and could lead to commercial licensing discussions between the two organisations.
BCAL said it also continues to collect clinical samples from patients across the US in collaboration with leading breast cancer specialists. Those samples will support BCAL’s Clinical Outcomes studies, which the company says are necessary for regulatory and reimbursement submissions.
Shane Ryan, Chief Executive Officer, BCAL, said, “This Validation Agreement with Sonic Healthcare USA is an important milestone for BCAL Diagnostics and our US commercialisation strategy. Sonic’s CLIA-certified laboratory infrastructure and deep expertise in clinical diagnostics provide the right environment to validate BreastestPlus™ Version 2. What excites me most is what this brings together — two highly capable teams, united by a shared purpose of delivering better diagnostic solutions for women at scale. We look forward to progressing through the validation process and advancing towards commercial deployment in the world’s largest breast cancer diagnostics market.”
Dr Mohamed Salama, Chief Medical Officer, Sonic Healthcare USA, said, “Sonic Healthcare USA is committed to advancing access to innovative diagnostic solutions that make a real difference to patients. The validation of BreastestPlus™ Version 2 at our CLIA-certified Sonic Reference Laboratory in Austin, Texas, reflects that commitment, and we look forward to assessing its performance through a rigorous validation process.”
The financial terms of the Validation Agreement were not disclosed.