Phenylketonuria. Most people won’t know what it is, let alone how to say it, let alone spell it. But for the few who do, they know it’s a serious birth defect that can have devastating effects.
Also known as PKU, phenylketonuria is a very rare, congenital disorder that causes a build up of amino acid phenylalanine in the body. Left untreated, the condition can harm the central nervous system causing brain damage, intellectual and behavioural disabilities and seizures.
Currently, screening of PKU via blood test is common practice amongst newborns in most developed countries. In an effort to make testing easier, US based Apatel Biosciences has partnered with experts in diagnostic medicine, Lumos Diagnostics (ASX: LDX) to develop a new diagnostic test for the disorder.
The proposed test will allow care providers to measure phenylalanine levels at home, or at the point-of-care in real time, allowing for earlier detection of PKU.
Seeing the value in such a test, the new product has been awarded breakthrough status by the FDA which will assist in fast tracking the product through the approval process.
Lumos expects to generate USD $0.5 million in the initial phase of the project, with more to come from additional product development activities. The new test is expected to be launched in CY2023 subject to approval from key regulators and manufacturers.
The partnership falls under Lumos’ Commercial Services division which develops and manufactures point-of-care tests on behalf of clients. Last financial year, the division accounted for 91% of the Company’s revenue, generating $22.7 million.
There is more of the market to conquer though, with global sales for point-of-care diagnostics generating USD $29.6 billion in 2020, a figure that has no doubt seen sharp increase with the advent of rapid antigen tests for COVID detection, and their rise to becoming a staple on the shopping list.
Commenting on the partnership and PKU test, Sam Lanyon, Lumos’ Interim CEO said: “We are very pleased that Apatek selected Lumos as its development partner following a competitive bidding process. Apatek’s objective of replacing a centralised PKU diagnostic test with a POC test that can be used in the home highlights the broad shift towards decentralised testing that has the potential to deliver better outcomes for patients. We are excited to be Apatek’s development partner for such an important product and look forward to continuing this relationship as the product moves into manufacturing and commercial launch.”
Samantha Freidin is a business journalist at Emerald Financial whilst also completing a Masters of Marketing and Digital Communications at Monash University.
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