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  • Lumos Diagnostics (LDX) secures a contract with Aptatek Biosciences to develop a product to assist with screening for phenylketonuria (PKU)
  • The Aptatek product aims to provide a point-of-care and at-home screening test to allow PKU patients to directly measure their phenylalanine levels in real-time
  • The initial phase is expected to generate at least US$500,000 (A$711,540) in revenue for Lumos with further potential revenue from additional development activities
  • Aptatek is aiming to commence further studies and activities using the test developed by Lumos in Q1 2023 with US commercial launch expected in late 2023
  • Shares in Lumos Diagnostics are down 6.9 per cent, trading at 13.5 cents as of 10:23 am AEST

Lumos Diagnostics (LDX) has secured a contract with Aptatek Biosciences to develop a product to assist with screening for phenylketonuria (PKU).

The Aptatek product aims to provide a point-of-care and at-home screening test to allow PKU patients to directly measure their phenylalanine levels in real-time.

This has the potential to allow more rapid identification and effective on-going management of the disorder.

PKU is a rare inherited disorder which causes an amino acid called phenylalanine to build up in the body and affects approximately 1 in 12,000 newborns. Left untreated, this build-up can result in intellectual disabilities, seizures, behavioural problems and mental disorders.

The diagnostic product has already been given breakthrough status from the US Food & Drug Administration (FDA) which is expected to accelerate its approval timeframe.

The initial phase of the contract is expected to generate at least US$500,000 (A$711,540) in revenue for Lumos, with further potential revenue from additional development activities and ongoing instrument manufacturing conducted in subsequent phases of the partnership.

Lumos interim CEO Sam Lanyon said the product development 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,” Mr Lanyon said.

Aptatek is aiming to commence further studies and activities using the test developed by Lumos in Q1 2023 with US commercial launch expected in late 2023.

Subject to regulatory approvals and execution of a commercial contract manufacturing
agreement, Aptatek said it intends to engage Lumos as the instrument manufacturing partner for the product.

Shares in Lumos Diagnostics were down 6.9 per cent, trading at 13.5 cents as of 10:23 am AEST.

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