Helena

Clinical Partners

Helena is validated and refined through partnerships with clinical genetics laboratories. Our partners use Helena in daily diagnostic practice and shape the platform with real clinical feedback.

Founding Clinical Partner

CellGenetics logo

CellGenetics

A leading Bulgarian laboratory for genetic diagnostics · Sofia · Plovdiv · Varna

The first and only genetic laboratory in Bulgaria specializing in advanced analysis and interpretation of whole-genome sequencing data. CellGenetics is the first clinical laboratory to validate Helena in real diagnostic practice and the reference standard against which every new development of the system is measured.

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How Partnerships Work

Clinical partnership is not a marketing arrangement. It is a working relationship built on shared standards, real diagnostic cases, and disciplined methodology.

Real diagnostic validation

Helena is tested against laboratory clinical reports signed by board-certified medical geneticists. Our partners use Helena in daily diagnostic practice and provide the reference standard against which the platform is measured.

ISO and IVDR-aligned methodology

Validation follows ISO 15189:2022, EU IVDR (2017/746), AMP/CAP Pipeline Validation Standards (2018), and ACMG/AMP Standards and Guidelines for Sequence Variant Interpretation (2015).

Continuous improvement

Each validation case strengthens the platform. Edge cases identified in clinical practice become permanent improvements. Concordance-driven development ensures that every partner case sharpens classification accuracy.

Become a Partner

We partner with clinical genetics laboratories, academic institutions, and research consortia. If your laboratory is interested in evaluating Helena or joining our validation program, get in touch.

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