CLEO Diagnostics (ASX:COV) has revealed it’s kicked off US-based trials sussing the reliability of its blood tests designed to detect ovarian cancer.
Eight recruitment centres in the US are involved with the tests specifically looking at the efficacy of Cleo’s tests in the US market. Ideally, the company will kick off an FDA application next year on the back of the trial datum.
The trial is notably large in scope, with the company hoping to amass no less than 500 patients to take part with a best-as-possible sample representation of the US population – recruitment is taking place in six different US states.
“Commencement of our US trials confirm a significant milestone for CLEO and sets a clear pathway now for our planned entry into the US,” COV CEO Richard Allman said.
“We have already demonstrated that CLEO’s ovarian cancer blood test is highly accurate, can detect early-stage cancer, and importantly is significantly better than clinical tools used today.
“It is important to note that no diagnostic test exists today for ovarian cancer.”
COV last traded at 36cps.