Rapid point-of-care (POC) diagnostic technologies specialist Lumos Diagnostics (ASX:LDX) has secured a development contract with New Jersey-based Aptatek Biosciences, Inc. to develop a product to assist with screening for phenylketonuria (PKU).
PKU is a rare inherited disorder which causes an amino acid called phenylalanine to build up in the body and affects approximately one in 12,000 newborns.
Left untreated, this build-up can result in intellectual disabilities, seizures, behavioural problems and mental disorders.
The Aptatek product, developed under contract with Lumos, aims to provide a point-of-care/at-home screening test to allow PKU patients to directly measure their phenylalanine levels in real-time. Such a test has the potential to allow more rapid identification and effective on-going management of the disorder.
The product has already been given breakthrough status from the FDA which is expected to accelerate its approval timeframe.
The initial phase of this partnership is expected to generate at least US$0.5 million in revenue for Lumos with further potential revenue from additional development activities and ongoing instrument manufacturing conducted in subsequent phases of the partnership.
Aptatek is aiming to commence further studies and activities using the test developed by Lumos in Q1 CY2023 with US commercial launch expected later in CY2023.
Subject to regulatory approvals and execution of a commercial contract manufacturing agreement, Aptatek intends to engage Lumos as the instrument manufacturing partner for the product.
“Aptatek is focused on providing transformational tools for improving the management of chronic diseases,” said Mike Boyce Jacino, CEO of Aptatek Biosciences Inc. “We are delighted to have Lumos as our partner in this ambitious effort.”
Lumos’ Interim CEO, Sam Lanyon, said Aptatek’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 Aptatek’s development partner for such an important product and look forward to continuing this relationship as the product moves into manufacturing and commercial launch.”