Genetic Signatures (GSS) - Preparing for Potential US Launch H2 FY24
The FDA review for 510(k) applications takes between 3 and 9 months, so we expect an FDA decision between December 2023 and June 2024.
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Genetic Signatures (GSS) - Sales Disappoint but Key Catalyst Approaching
GSS reported $2.0m sales in Q323, falling below our expectations as Covid and other respiratory testing tailed off more quickly than we had...
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Genetic Signatures (GSS) - FDA Clearance Remains Key Despite Submission Delay
The FDA submission is now expected before the end of April vs AGM guidance targeting December and our assumption of Q1 CY23.
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Genetic Signatures (GSS) - On Track for US Launch in 2023
GSS is preparing to file for FDA clearance of its Enteric Protozoan kit, which offers unrivalled capacity to detect these important causes of...
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