Lumos Diagnostics expands scope of work under Hologic fetal fibronectin development agreement

Lumos Diagnostics Holdings Ltd has inked an agreement with leading women’s health company, Hologic, Inc, to expand the scope of work under the development agreement covering the new fetal fibronectin (fFN) test.

Phase 3 of the development agreement, which involves the delivery of the system prototype, will now include additional hardware features in the proprietary reader technology.

The expanded scope is expected to generate additional revenue of between US$600,000 and US$800,000, to be invoiced as the work is completed over the coming months.

Phase 2 on track for April

"We are extremely pleased with the progress of the Hologic fFN project,” Lumos Diagnostics managing director Doug Ward said.

“Phase 2 of the project is progressing well and is expected to complete around April 2025, triggering the second of the Phase 2 milestone payments, worth US$300.000.

“In collaboration with the Hologic team, Phase 3 will now deliver a more feature-rich product."

The development agreement is being conducted over three phases with total milestone payments of up to US$4.7 million, as follows:

• Phase 1, Product Definition and Planning - define the parameters for the product and establish a project plan - US$400,000 - completed as announced on May 6, 2024. Payment has been received for this phase;
• Phase 2, Assay Feasibility - conduct work to demonstrate the assay can detect the biomarker - US$600,000 – work on the first milestone of this phase has been completed, comprising US$300,000 payment, as announced on September 20, 2024, and payment has been received. Work on the second and final milestone for this phase, worth $300,000, is ongoing and expected to complete by around April 2025; and
• Phase 3, System Prototype Delivery - deliver a working prototype of the system - US$3.7 million. Work on this phase has begun and is expected to complete by around December 2025.

With the expanded scope of works, the total value of the agreement is now estimated at US5.3 million to US$5.5 million.