Cleo Diagnostics announced the commencement of US clinical trials for its ovarian cancer diagnostic blood test.
The trial aims to validate the test's use for entry into the US market, with data collected to support a submission to the Food and Drug Administration.
The pivotal FDA-enabling trial started with the first patient recruitment across eight medical institutions in six US states.
The study will benchmark Cleo's technology with a target recruitment of at least 500 patients.
Eligible participants will be identified by their primary physicians during consultations.
"Commencement of our US trials confirm a significant milestone for CLEO and sets a clear pathway now for our planned entry into the US market," commented CEO Richard Allman.
"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," he added.
Allman emphasised the urgency and market potential for this diagnostic tool, noting that no comparable test currently exists, and diagnosis today can only be made post-surgery.
"The opportunity in front of us is immense, and CLEO is well positioned and funded to achieve access into our initial pre-surgery test market," he added.
Cleo Diagnostics is an ovarian cancer diagnostics company. Its principal activities involve the development and patent of a blood test for the detection of ovarian cancer.
It focuses on bringing to market a blood test for the early diagnosis of ovarian cancer based on the novel CXCL10 biomarker, which is produced early and at high levels by ovarian cancers but is largely absent in non-malignant diseases.