Lumos says it achieves first Phase 2 milestone in hologic fFN development agreement

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Point-of-care diagnostic company Lumos Diagnostics (ASX:LDX) has announced that it has completed a milestone under Phase 2 of its development agreement to develop a new fetal fibronectin (fFN) test for women’s health company Hologic.

In January 2024, Lumos announced that it had signed two new agreements with US-based Hologic. The agreements are an intellectual property agreement valued at US$10 million and a development agreement valued at US$4.7 million.

The agreements focus on developing a next-generation version of Hologic’s on-market fFN diagnostic product for pre-term birth, a women’s health product for which Hologic is the only manufacturer globally.

Lumos said the development program focuses on adapting the test for use on its proprietary reader platform and providing improved connectivity options.

Lumos said Hologic has confirmed that it has completed the first milestone under Phase 2 of the agreement. Phase 2, focused on assay feasibility, where Lumos is conducting work to demonstrate the assay can detect the biomarker, is valued at US$0.6 million, with US$0.3 million awarded under the achievement of this first milestone.

Lumos CEO and managing director Doug Ward said, “We are proud to receive this milestone payment, which demonstrates the strong progress the Lumos and Hologic are making in developing a new fetal fibronectin (fFN) test. We're excited by the results of the work program to date and are pressing ahead with the remainder of the scoped work under Phase 2 of the agreement.” With the first milestone under Phase 2 complete, Lumos is now continuing to work on the remaining milestone work under this phase of the project."