• Lumos and Hologic are expanding scope of work for new fetal fibronectin (fFN) test to detect premature birth
  • Expanded work to deliver new hardware features to Hologic with an additional fee to Lumos of between US$600k to US$800k
  • Phase 2 of development agreement expected to complete around April 2025, Phase 3 by December 2025

 

Special Report: Known for its rapid point-of-care testing technologies, Lumos Diagnostics has made an agreement with leading women’s health company Hologic Inc to expand the scope of work for a new test to determine risk of premature birth.

In January 2024 Lumos Diagnostics (ASX:LDX) announced that it had signed two new agreements with Hologic focused on development of a next-generation version of the Nasdaq-listed company’s on-market fetal fibronectin (fFN) diagnostic test for detecting pre-term birth – a women’s health product for which Hologic is the only manufacturer globally.

The deals included an intellectual property agreement valued for Lumos at US$10 million and a development agreement valued at US$4.7 million.

A key focus of the development program is to adapt the test for use on the Lumos proprietary reader platform and provide improved connectivity options.

The newly announced expanded scope of work relates to Phase 3 of the development agreement, which focuses on the delivery of the system prototype, and will include incorporating additional hardware features into the proprietary reader technology.

The expanded scope of work is estimated to generate additional fee revenue for Lumos of between US$600k to US$800k, which will be invoiced as the work is completed over coming months.

 

Three-phase development deal

The body of work under the development agreement is being conducted across three phases, providing total milestone payments of up to US$4.7 million.

  • Phase 1 – product definition and planning: This includes defining the parameters for the product and establishing a project plan worth US$400k. Lumos announced in May 2024 that Phase 1 had been completed with payment received.
  • Phase 2 – assay feasibility: Conduct work to demonstrate the assay can detect the biomarker worth US$600k. Lumos said work on the first milestone of this phase had been completed in September 2024 with a US$300k payment received.

The company noted that work on the second and final milestone for this phase, worth US$300k, is ongoing and is expected to complete by around April 2025.

  • Phase 3 – system prototype delivery: Deliver a working prototype of the system – US$3.7m.

Work on this phase has started and Lumos expects it to complete by around December 2025.

Lumos said the value of Phase 3, including the expanded scope of work, is now between US$4.3m to US$4.5m, bringing the total value of the development agreement to around US$5.3m to US$5.5m.

The total project timeline is now expected to be around 24 months, running from January 2024 to December 2025, including the additional hardware scope of work announced.

 

A ‘feature-rich product’

Lumos managing director Doug Ward said the company was extremely pleased with the progress of the Hologic fFN project.

“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,” he said.

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

“Lumos will continue to keep the market updated as we progress through the remaining milestones under the Development Agreement.”

 

 

This article was developed in collaboration with Lumos Diagnostics, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Read MoreHealth

Featured Companies

You might be interested in