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How Cleo Diagnostics Cleared a Major Regulatory Hurdle for Ovarian Cancer Test
9:56am on Thursday 30th of October, 2025 AEDT
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Healthcare
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How Cleo Diagnostics Cleared a Major Regulatory Hurdle for Ovarian Cancer Test
9:56am on Thursday 30th of October, 2025 AEDT
Key Points
Stage 1 MDSAP audit completed successfully
Positive regulatory feedback on quality management system
Streamlined pathway for FDA submission and global market access
Stage 2 audit scheduled for Q2 2026
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