Shares in GENinCode PLC (AIM:GENI) fell 30% on Monday after the company said the US Food and Drug Administration (FDA) was still asking for more information before it would approve its lead cardiovascular test.
The update followed a Supervisory Review requested by the company, which had hoped to overturn or ease the agency’s earlier decision.
While the FDA acknowledged progress and reduced the number of outstanding issues, it maintained that further clinical validation was needed before granting De Novo classification, an approval pathway for new medical devices.
GENinCode, which develops genetic tests aimed at preventing heart disease, said it continues to believe it can address the regulator’s concerns and has already scheduled further talks with the FDA.
However, it also admitted there was no guarantee the agency would be satisfied with the additional data.
The company said it would issue another update if those discussions yield new information.
The stock fell 0.68p to 1.56p.