A recent report revealed that, in the US, the rate of babies being born prematurely has been rising. Between 2014 and 2022, premature births grew 12% to 8.7%. This paints a concerning picture for mothers and infants who face great risk.
To address this, point-of-care diagnostic technologies Lumos Diagnostics (ASX: LDX) has been working on developing a test that would help detect the risk of premature births early on.
The Company has completed the first phase of its Development Agreement to develop a new fetal fibronectin (fFN) test for US-based women’s health company Hologic. The first phase of the development agreement, focusing on Product Definition and Planning, was valued at $600k. $300k was recognised in Q3 FY24, and the remaining $300k will be booked in Q4 FY24.
On January 11, 2024, Lumos announced that it had signed two new agreements with the US-based women’s health company: an intellectual property agreement valued at $15.14 million and a development agreement valued at $7.11 million.
Lumos CEO and Managing Director, Doug Ward commented, “We are very pleased to have completed this critical first phase of this Development Agreement with Hologic. Achieving milestone approval from Hologic is excellent validation of the project work completed by the Lumos team, whilst providing additional strength to the company balance sheet through further project funding and a positive outlook on the likelihood of Lumos delivering on subsequent phases.”
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. A key focus of the development program is adapting the test for use on the Lumos proprietary reader platform and providing improved connectivity options.
He added, “As Hologic is the only global manufacturer of this important prenatal test, we feel a strong responsibility toward successfully developing the next generation of the test on the Lumos reader platform.”
Lumos Diagnostics specialises in rapid and complete point-of-care diagnostic test technology, helping healthcare professionals diagnose and manage medical conditions. It offers customised assay development and manufacturing services for point-of-care tests and proprietary digital reader platforms.
The fFN test is the largest segment in the pre-term diagnostic test kit market in the United States. The test is focused on the fFN protein, which is found at the maternal-fetal interface. As delivery approaches, the protein is increasingly detectable and its detection (in pregnancy weeks 22 – 35) can indicate that a woman is at higher risk of preterm delivery.
A positive fFN result indicates an increased risk of delivery in the next 14 days. The US annual pre-term birth total addressable market is approximately 2.5 million tests per annum, and the US reimbursement rate for fFN is $97.4 per test.
With Phase 1 complete, Lumos is now preparing to commence Phase 2 of the Development Agreement, entitled Assay Feasibility. This phase is designed to demonstrate that the assay can detect the biomarkers associated with the new fFN test, i.e. that Lumos’s test can accurately detect the protein.
Once Phase 2 is complete, its third phase—valued at $5.6 million—would focus on System Prototype Delivery, involving the delivery of a working prototype of the system.
Alinda is a Business Reporter for The Sentiment
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1 Comment
Shraddha13
Thank you for sharing! To explore further
Replyhttps://www.360iresearch.com/library/intelligence/preterm-birth-prom-testing