Still a relatively recent arrival to the bourse, Cleo Diagnostics (ASX:COV) has announced it’s commenced the FDA regulatory process to get into the US market.
Cleo is hoping to take overseas its ovarian cancer blood test kits, which represents a huge market given the tests detect cancer instead of treating it – meaning the kits could be of interest to local GPs all across the continent, all cards in order.
So far, Cleo’s C-suite and experts have met up wth FDA reps where the company outlined its submission framework and clinical testing plan. That was jus a pre-submission meeting.
However, the company cited “positive feedback” from the FDA.
The design of its clinical trial – wherein data proving the tests are effective and safe will be collected – has now been approved in both the US and Australia, which is perhaps the biggest signal to pay attention to.
Of course, now Cleo needs to consistently prove its blood tests are superior at detecting ovarian cancer successfully.
With the pre-submission meeting wrapped up, the company is also hopeful it can spot loose ends where it could make the application process happen faster across the board.
Cleo is also pursuing fast-track pathways within the American regulator to expedite an approval for its devices (the test kits.)
COV last traded at 30.5cps.