Clinical sample access

Clinical data from outside the EU can be used, but only if:

• Informed consent and ethical standards are met

• Data quality and traceability are robust

• The study population is comparable to European patients

Why it matters: genetics, disease prevalence, diet, and medical practices differ. Some pathogens have variants that change test performance. What works in one region may not be valid for EU patients.
Pro Tip: Always document how your non-EU study population is equivalent to EU patients. If not, bridging data may be needed.

This is why at Amarok Biotechnologies we propose bridging studies and clinical samples recruitment according to these rules. Behind each specimen there is a patient with his/her history and surrounding, that impact the way the diagnostic system will respond.
Equivalence must be proven