28th May 2019 12:35
LONDON (Alliance News) - Renalytix AI PLC on Tuesday said it has secured a clinical laboratory improvement amendment certificate for its commercial laboratory in New York, US.
The clinical diagnostics company said the certificate was issued by the New York State Department of Health and is an important initial step in the process towards certifying Renalytix to conduct commercial operations for testing patients in the state of New York.
Renalytix said its New York laboratory will now therefore be scheduled for an on-site survey by the State of New York Department of Health.
All clinical and forensic laboratories located in, or accepting patients from, New York state must hold a New York State Department of Health clinical laboratory permit. Renalytix said it would be eligible for such a permit after successful completion of proficiency testing, on-site survey and validation requirements.
The stock was trading 3.4% lower on Tuesday at 195.10 pence a share in London.
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