Lumos hits milestone as it develops test to predict premature birth

Lumos achieves first milestone in second phase of its development agreement to develop a new foetal fibronectin (fFN) test for Hologic, Inc.
The fFN protein is found at the maternal-foetal interface and leaking into the vagina during the later stages of pregnancy indicates an increased risk of pre-term delivery
US$300,000 will be awarded to Lumos for achievement of the first Phase 2 milestone

Special Report: Lumos Diagnostics has reached the first milestone in the second phase of its development agreement to create a new foetal fibronectin (fFN) test to help indicate a pregnant woman’s risk of delivering prematurely for Nasdaq-listed Hologic.

Point-of-care diagnostic technologies company Lumos Diagnostics (ASX:LDX) has announced it has successfully completed a milestone under Phase 2 of its development Agreement to develop a new fFN test for leading women’s health company, Hologic Inc.

In January LDX announced it had inked two new deals with leading women’s health company Hologic including an intellectual property agreement valued at US$10m and a development agreement valued at US$4m.

The agreements focus on development of a next generation version of Hologic’s on-market fFN diagnostic product for pre-term birth, for which LDX said Hologic was the only manufacturer globally.

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

Three phase development structure

LDX said the development agreement was divided into three phases, with total milestone payments up to US$4.7m.

Phase 1 – Product definition and planning (completed, US$400k)

Phase 2: Assay Feasibility (US$600k)
Phase 3: System Prototype Delivery (US$3.7m)

LDX said phase 2 of the development agreement is focused on assay feasibility, where LDX is conducting work to demonstrate the assay can detect the biomarker.

The company will receive US$300,000 for achieving the first Phase 2 milestone in ~45 days.

With the first milestone complete, LDX is continuing to work on the remaining milestone work under Phase 2 the project.

Sought-after test

LDX said the fFN test is the largest segment of the pre-term diagnostic test kit market in the US.

The test detects the fFN protein, which functions like a glue to bind the baby to the uterus during foetal development. Detection of fFN protein in vaginal secretions in the later stages of pregnancy indicates an increased risk of pre-term delivery.

The annual US market is ~2.5 million tests, with a reimbursement rate of US$64.41/test.

Phase 2 of the development agreement is centred on assay feasibility, where LDX is working to demonstrate that the assay can detect the biomarker.

“We are proud to achieve this milestone, which reflects the strong progress Lumos and Hologic are making in developing a new fFN test,” LDX CEO and managing director Doug Ward said.

“We’re excited by the results so far and are pressing ahead with the remaining work under Phase 2.”

In some further good news, LDX recently announced a wholly owned subsidiary of Andrew and Nicola Forest’s private investment vehicle Tattarang was set to become its largest shareholder, with Tenmile acquiring 45m shares from Planet Innovation, representing a 9.3% holding.

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.