Lumos Diagnostics secures additional US$5m for pioneering pre-term birth test development

Lumos Diagnostics (ASX: LDX) has received a second US$5 million payment from women’s health firm Hologic Inc under an intellectual property (IP) agreement signed between the two companies in January.

The agreement grants Hologic an exclusive licence to use Lumos’ proprietary reader and point-of-care technologies in the development of its fetal fibronectin (fFN) test targeting the fFN protein located at the maternal-fetal interface.

Detecting fFN before the 35th week of pregnancy can indicate a higher risk of pre-term delivery.

This payment increases the total amount received under the IP agreement to US$10m.

Next-generation test

Lumos’ technologies will be integrated into a next-generation version of Hologic’s existing fFN diagnostic product for pre-term births.

The product is currently under development by Lumos, with a focus on adapting the test for use on the Lumos proprietary reader platform and enhancing connectivity options.

The fFN test constitutes the largest segment in the US pre-term diagnostic test kit market, with Hologic its sole global manufacturer.

Ongoing agreement

Lumos completed the product definition and planning for the new test in May under Phase 1 of a development agreement with Hologic.

This triggered a US$400,000 payment from Hologic, half of which will be recognised by Lumos in the third quarter of the 2024 financial year, with the remaining half booked in the fourth quarter.

Phase 2 of the agreement, valued at US$600,000, will concentrate on work to demonstrate that assays can detect certain biomarkers associated with the new test.

Phase 3, valued at US$3.7m, will focus on developing a working prototype.

Vital support

Lumos managing director Doug Ward stated that Hologic’s support is integral to the development of the fFN test.

“Receiving the second payment further solidifies our relationship with Hologic and provides greater balance sheet support and flexibility to execute our long-term strategic goals,” he said.

“There is a great need for improved women’s health initiatives globally, and we are pleased to be associated with leading women’s health advocates such as Hologic.”