Patient Selection and Clinical Use

Galleri® is a screening test; it is not for symptom evaluation or diagnosis but for additional screening in asymptomatic individuals. This article summarizes patient eligibility and the prescribing process.

Who Is Eligible?

• Asymptomatic adults aged 50 and over
• People with a family history of cancer
• Long-term smokers and those with occupational carcinogen exposure
• People with a previous cancer history under follow-up (with physician evaluation)

Who Is Not Eligible?

• Pregnant women
• Individuals aged 21 or under
• People undergoing active cancer treatment
• Those seeking inherited risk estimation (e.g. BRCA) — Galleri® is not used for this purpose
• Symptomatic patients with suspected cancer — they should be directed to diagnostic evaluation first

Prescribing and Sampling Process

1. Patient eligibility: pre-assessment on age and risk factors; symptom screening.
2. Prescription: the test is administered with a prescription; physician matching is provided for patients without one.
3. Blood draw: 2 Streck cfDNA tubes; via the Omega Çare home nurse service in all 81 provinces or at the Omega Genetik Beytepe (Ankara) laboratory; no fasting required.
4. Shipping: Ministry of Health-registered biological material transfer with cold-chain courier.
5. Result: delivered to the physician within approximately 2 weeks; if a signal is found, the diagnostic work-up is planned with the CSO prediction and genetic counseling is provided where needed.

Post-Result Governance

A detected signal does not mean a definitive diagnosis; next steps (imaging, specialist consultation, tissue sampling if needed) are planned by the physician. Even when no signal is detected, national guideline screening programs (mammography, colonoscopy, low-dose CT etc.) continue as usual.