Meet Lumos Diagnostics – the latest diagnostic testing company that’s listing on the ASX and wants an FDA green light
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Point of care diagnostic test provider Lumos Diagnostics (ASX:LDX) is set to list on the ASX on July 5.
The company was founded in Melbourne in 2015 and is still headquartered there but has manufacturing facilities in California and Florida.
Lumos Diagnostics’ products include FebriDx which is a finger-prick blood test that can indicate if a person has a general bacterial or viral acute respiratory infection within 10 minutes.
“It is designed as sort of a broad spectrum diagnostic test – the idea is it detects the host’s immune response so it works across a wide variety of diseases,” executive chair Sam Lanyon told Stockhead.
The company has applied to the FDA for the test to be approved and if it is granted, it will be permitted to sell it in the USA and potentially with an easy pathway for approval in certain other juristictions too.
“For point of care – the US is the largest market in this space, so it’s important – it’s 65 per cent of our market for us,” explained Lanyon.
“So that’s the reason the FDA [approval] is important to us but it it also sets a high bar.
“The great thing for us is the FDA has accepted some of [our] external real world studies as part of our database which is quite pleasing considering the situation they’ve been in due to COVID.
“Because as you can imagine the FDA have been swamped by applications mostly to do with COVID.
“We’re not strictly a COVID test; we’re much more broader than that – but they’ve been looking at our tests and a lot of companies haven’t been getting any attention.”
Lumos Diagnostics is seeking $63 million at $1.25 per share from investors and has hired Wilsons and Bell Potter as joint lead managers.
Arguably, the most similar company on the ASX is Atomo Diagnostics (ASX:AT1) which manufactures rapid tests for HIV/AIDs as well as COVID-19.
It listed in April 2020 soon after COVID-19 first broke out and nearly doubled on debut but has retreated since.
This is in spite of the company continuing to report heavy demand for its tests.
Two other companies in the space are Rhythm Biosciences (ASX:RHY) – which is working on a blood test to detect colorectal cancer – and Genetic Technologies (ASX:GTG) which has been developing its own test for breast cancer.
There are a handful of other companies that are more generalist pathology stocks including larger caps Sonic Healthcare (ASX:SHL), Healius (ASX:HLS) and Australian Clinical Labs (ASX:ACL) as well as small cap Virtus Health (ASX:VRT).