The Milestone: Laboratorio Echandi’s Next-Generation Sequencing (NGS) Department has been accredited under the INTE/ISO 15189:2023 standard, making it the first clinical laboratory in Costa Rica certified in the Specialized and Study Laboratory category.

Scope of Accreditation: Specifically covers the analysis of variants in the BRCA1 and BRCA2 genes, which are primarily linked to hereditary predisposition for breast and ovarian cancer (part of ECA file LM-008).

Local Processing (No Foreign Out-Sourcing): Laboratorio Echandi is currently the only private laboratory in Costa Rica that processes BRCA1 and BRCA2 tests locally, eliminating the need to send these samples abroad.

Advancing Precision Medicine: Having this local capacity strengthens access to precision medicine, giving doctors and patients vital genetic risk information within their personal and family clinical contexts.

Clinical Utility: Identifying pathogenic variants in these genes helps guide screening, prevention, and management strategies for both patients and their families.

1. Hereditary Breast, Ovarian, and Endometrial Cancer Panel:
   1. Utilizes NGS technology to analyze genes linked to hereditary cancer predisposition, including BRCA1, BRCA2, PALB2, CHEK2, ATM, and genes related to Lynch syndrome.
2. OncoClever (162-Gene Panel):
   1. An expanded oncological panel studying 162 genes involved in various hereditary cancer syndromes for comprehensive evaluations.

Doctors and patients typically evaluate these tests when personal or family histories suggest potential hereditary predisposition, such as:

• Relatives diagnosed with cancer at an early age.
• Multiple cancer cases within the same family.
• Family histories compatible with hereditary cancer syndromes.
• Known hereditary cancer mutations previously identified in maternal or paternal family lines.

The accreditation evaluates technical competency, metrological traceability, method verification, quality control, and risk management—reinforcing the growth of clinical genomics and continuous quality improvement in Costa Rica.

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