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Embrace the journey, stay consistent, and celebrate every milestone along the way

The outlook for the market remains positive, supported by rising health awareness, expanding reimbursement frameworks, and sustained technological advancement

Berglund LM, Lyssenko V, Ladenvall C, Kotova O, Edsfeldt A, Pilgaard K, Alkayyali S, Brons C, Forsblom C, Jonsson A, et al

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The FDA does not adjudicate patent validity, but it does review whether a submitted patent meets the listing criteria, and incorrectly listed patents carry legal and regulatory exposure under the False Claims Act and FDA regulations

The FDA decision is anticipated in October 2025