PathGEN Dx Consultancy

Based in Singapore, we provide consultancy services in the following areas:

• Clinical molecular diagnostics laboratory design and operation

• Clinical NGS assays

• Regulatory approval and laboratory accreditation - College of American Pathologists (CAP), ISO13485

• Diagnostic test development, validation and commercialization

• Medical device development, validation and commercialization

• US FDA medical device registration

• Management advice to improve efficiency (organization processes, product efficacy)