Bitscopic Commercializes PraediGene to Automate Genomic Variant Interpretation and Make Clinical Genomics Programs Inspection-Ready
SEATTLE, WA — [February 25, 2026] – Bitscopic today announced the commercialization of PraediGene, a clinical-grade platform designed to help laboratories scale genomic testing with reproducible variant interpretation, audit-ready decision trails, and standardized reporting across clinical domains. PraediGene has served as a core infrastructure component within the U.S. Department of Veterans Affairs (VA) clinical genomics programs and is now available to clinical laboratories and reference labs.
As clinical genomics programs expand, many laboratories are operating with limited visibility into the interpretation logic behind reported results. With rising expectations for validation, inspection readiness, and change control in regulated clinical environments, that lack of transparency becomes more than an efficiency problem. It creates an accountability gap when lab leaders need to answer questions such as: What evidence supported this call? What rules were applied? What changed over time?
In practice, that means supporting regulated clinical laboratory workflows where interpretation logic must be reproducible, reviewable, and inspection-ready. This is particularly important for laboratories running Laboratory Developed Test (LDT) programs under CLIA/CAP expectations, where inspection-ready documentation and controlled change matter.
PraediGene addresses that gap by standardizing dry lab workflows from raw data inputs through interpretation and reporting, while preserving a versioned, reviewable decision trail for every call. This approach helps laboratories maintain consistency across teams and sites, reproduce results reliably over time, and support internal quality review and external inspection workflows.
“Automation alone isn’t enough. Labs need inspection-ready automation,” said Joel Mewton, Chief Technology Officer at Bitscopic. “PraediGene captures not just the result, but the evidentiary trail of why and how a classification was made. That’s what allows clinical genomics programs to scale safely.”
Built for inspection-ready workflows
PraediGene is designed around a simple principle: in clinical genomics, the result is not enough. Laboratories must be able to stand behind how a call was made, reproduce it later, and manage change as policies evolve.
PraediGene supports that requirement through:
- Interpretation you can stand behind: grounded in ACMG/AMP guidance and designed to support consistent classification rationale.
- Calls you can trust: evidence-linked, reproducible, and traceable decision trails to support review and audit readiness.
- Reporting clinicians can use: standardized, clinician-friendly outputs that reduce variability and manual assembly across domains and sites.
- Governance that holds up: versioning and controlled change processes to support validation and change control expectations.
Across the clinical genomics menu
PraediGene is designed to support standardized interpretation and reporting workflows across major clinical domains, including molecular oncology (somatic), molecular genetics (germline), infectious disease, cytogenetics-related reporting needs, and pharmacogenomics (PGx). This platform approach enables teams to scale programs without multiplying tools, rule sets, and reporting formats as volumes grow and new workflows are introduced.
Built to fit real lab environments
PraediGene focuses on the interpretation, governance, and reporting workflows and is designed to fit into existing lab environments without requiring changes to wet-lab workflows. The platform supports structured review and sign-out workflows aligned to laboratory policy, helping teams reduce downstream burden while maintaining clinical oversight.
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