Cleo Diagnostics (ASX:COV) has taken a significant step toward its planned U.S. market launch, appointing prominent gynaecologic oncologist Dr Nicholas Lambrou as its first U.S.-based Key Opinion Leader (KOL).
The move marks a significant milestone in the company’s commercialisation strategy for its pre-surgical ovarian cancer test, as it prepares to enter its most important and influential healthcare market.
Dr Lambrou is widely regarded as an expert in gynaecologic oncology, complex pelvic surgery, and women’s health, with clinical training at Johns Hopkins and the University of Miami. Across his academic and clinical career, he has authored numerous publications, contributed to primary surgical texts, and participated in some of the most advanced therapeutic trials in ovarian and gynaecologic cancers. He is also actively recruiting patients into Cleo’s U.S. clinical trial.
In accepting the role, Dr Lambrou said, “I am thrilled to join CLEO at such a pivotal point in its journey. Backed by more than 15 years of rigorous scientific research, CLEO’s work has reached a point where it can now be translated into real clinical practice, where it has the potential to make a profound difference. As a surgeon who confronts the diagnostic uncertainty around ovarian cancer every day, I see enormous value in a pre-surgical test that can bring greater accuracy, confidence, and clarity to women, doctors and gynaecologic oncologists. I look forward to working with the CLEO team to help introduce this innovation into the U.S. healthcare system and advance a new standard of care for women."
Cleo Chief Executive Officer, Dr Richard Allman, said the appointment marks an important moment in the company’s commercialisation plans. “Appointing Dr Lambrou as our first KOL marks a meaningful milestone in our market-entry preparation. His clinical leadership, experience, and proximity to the U.S. market, being our largest commercial opportunity, will support CLEO’s staged execution strategy, ensuring our technology is introduced with the right clinical voices, scientific credibility, and pathways for early adoption.”
The company plans to expand its advisory and KOL network as it progresses toward FDA submission and commercial launch next year. At the centre of its platform is a patented biomarker, CXCL10, identified and validated over more than 15 years of research.