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CLEO Diagnostics (ASX:COV), a company developing a simple blood test for ovarian cancer for use in surgical triage, has commenced the “technology transfer” process to a U.S.-based manufacturing partner ahead of commercialisation.
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In the background, it’s receiving advisory assistance from U.S.-based R&D Systems Inc, an immunoassay technology giant part of the Bio-Techne Group eventually responsible for mass producing the antibodies Cleo’s tech relies on. That is to whom technology transfer has begun.
The larger manufacturer in question won’t be R&D Systems – they’ll just be handling antibodies and a prototype.
The actual manufacturer wasn’t named by Cleo on Tuesday because it hasn’t yet been selected, but there are multiple candidates described as FDA-registered.
In between the lines, it sounds like the ‘technology transfer’ is in the very early stages and Cleo mightn’t know who it’s going with just yet.
“Final negotiations are underway with selected FDA-registered CMO’s ahead of transition to large-scale manufacturing,” Cleo wrote in a release on Tuesday.
It’s likely that R&D Systems will have a say.
While the company is only developing ‘prototype kits’ ahead of a full-blown manufacturing run, all cards in order, the company may have partners in mind.
“The partnership with R&D Systems ensures the successful progression of commercial prototype development and supports CLEO’s transition to large-scale manufacturing,” Cleo wrote.
“Following successful testing, CLEO’s selected [manufacturer] will assist in scaling production capability, in addition to verification and validation activities.”
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By teaming up with US entities with US regulatory know-how, Cleo is farming data for its larger overhead strategy – a path to eventual FDA approval.
COV last traded at 47cps.
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