Helix Studio Positioning
Canonical statement
Helix Studio is a pre clinical, in silico genome editing simulation platform and Genome IDE for research, education, and hypothesis exploration. It does not provide clinical decision support and is not intended for diagnostic or therapeutic use.
What Helix Studio is
- A genome IDE for exploring genome edits and simulated outcomes
- A deterministic, replayable simulation environment
- A tool for research workflows, education, demos, and hypothesis exploration
- A producer of auditable artifacts such as manifests, FASTA, and VCF for downstream non clinical analysis
What Helix Studio is not
- Not a clinical pipeline
- Not a diagnostic tool
- Not a therapeutic recommendation system
- Not a substitute for medical judgment
- Not intended for patient specific decision making
Clinical boundary rules
- Do not accept or store patient identifiers
- Do not ingest patient clinical metadata
- Do not produce recommendations for treatment, diagnosis, or therapy
- Do not score edits in terms of patient outcomes
- Do not integrate with EHR systems, LIMS, or hospital workflows
- Do not use language that implies clinical use
Language rules
Allowed terms
- simulation
- model
- hypothetical
- scenario
- pre clinical
- in silico
- exploration
- research use
- education
Forbidden terms
- patient
- diagnosis
- therapeutic
- therapy
- treatment
- prescribe
- cure
- efficacy
- clinical decision support
- medical device
If any forbidden term is necessary in documentation, it must appear only inside this file or inside a section explicitly describing what Helix Studio is not.
Brand note
If someone asks whether Helix Studio can be used clinically, the answer is:
Helix Studio is for pre clinical, in silico simulation and exploration only. Any clinical use would require a separate product track with formal validation and regulatory compliance.