ViroGates Submits De Novo Application To U.S. FDA For suPARnostic TurbiLatex

April 9 (Reuters) - ViroGates A/S VIROG.CO:

• SAID ON WEDNESDAY SUBMITTED A DE NOVO MARKETING APPLICATION, FORMALLY REFERRED TO AS A "DE NOVO CLASSIFICATION REQUEST", TO THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) FOR ITS SUPARNOSTIC TURBILATEX PRODUCT

• RESTATES ITS PREVIOUSLY ANNOUNCED GUIDANCE AND EXPECTS 2026 REVENUE BETWEEN DKK 6 AND 7 MILLION AND AN EBIT OF DKK -10 TO -12 MILLION