Lumos Diagnostics Secures Follow-On Contract to Manage Study to Advance In-Home Phenylketonuria Monitoring Device to Support US FDA Clearance

MT Newswires Live

Jan 19

Lumos Diagnostics Holdings (ASX:LDX) secured a follow-on contract with Aptatek Biosciences to manage the institutional review board-approved multi-center study to advance an in-home monitoring tool for the screening and management of phenylketonuria to support clearance from the US Food and Drug Administration, according to a Monday Australian bourse filing.

Lumos will provide clinical study support services, from startup through to close-out, including compilation and statistical analysis of the results and generation of the clinical study report for submission to the US FDA. The study is expected to start in the second quarter and run for around six months.

This new contract is valued at around $400,000, which will be charged on a time-and-materials basis.

The firm's shares rose 2% in recent trading on Monday.

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