-- Cleo Diagnostics (ASX:COV) started a staged manufacturing and development program with life sciences firm Bio-Techne to support production of its ovarian cancer test kits, according to a Tuesday filing with the Australian bourse.
The program will generate the test kits required for analytical validation and the evaluation of the clinical samples collected as part of the company's US study, the filing said.
Data from analytical validation and clinical sample testing will form the core evidence package for the company's US Food and Drug Administration 510(k) submission, per the filing.
Cleo Diagnostics shares rose 8% in midday trade on Tuesday.