Cleo Diagnostics begins validation testing for ovarian cancer test

• Cleo Diagnostics launched formal regulatory testing for its pre-surgical ovarian cancer test.
• Testing began after receiving 125 test kits from manufacturer Bio-Techne.
• The data collected will support an FDA 510(k) submission planned for early 2027.

Cleo Diagnostics (ASX:COV) has commenced analytical validation testing for its pre-surgical ovarian cancer test to prepare for regulatory approval in the United States.

The milestone follows the delivery of 125 production test kits from partner Bio-Techne (NASDAQ:TECH) and the completion of initial internal preparations.

The validation programme evaluates three independent production batches across Bio-Techne's automated platform over approximately three months.

In parallel with this phase, the company stated that it will progress to clinical validation trials.

Following the announcement, the Cleo Diagnostics share price was unchanged at $0.34.

The company is developing blood-based diagnostic tools aimed at improving early detection and surgical planning for ovarian cancer patients.

It plans to use the resulting trial data to support a formal FDA submission in the first half of 2027.