SaMD · FDA De Novo · Biotherapeutic safety · WGS

From WGS data to clinical resistance answers — and regulatory safety documentation.

Two software products that solve distinct, unmet problems: BengiAI‑AMR gives clinicians actionable resistance calls hours before culture-based testing responds. SafetyGenome delivers the AMR safety characterization that FDA, EFSA, and USDA require for every biotherapeutic, agricultural, and animal health submission.

Discuss a partnership →

Platform products

Flagship · Clinical diagnostics · SaMD

BengiAI‑AMR

Converts WGS output into resistance predictions with calibrated probability scores and 95% confidence intervals — enabling clinical action hours before culture-based testing responds.

Capabilities

14 prediction models · 9 antibiotic classes · 48+ genera
Binary R/S call + probability score + 95% CI per prediction
Uncertainty quantified on every call — not suppressed
Results in 7–12 hours alongside WGS workflow
Designed to FDA requirements

Target users

Clinical microbiology labs at academic medical centers
Antimicrobial stewardship programs (AMSPs)
Hospital WGS diagnostic workflows

FDA De Novo — first-in-class, no cleared predicate · Built to FDA IVD AST Guidance (2022) · CLSI EP12-A2 analytical validation

Pipeline product · Biotherapeutic safety · CMC

SafetyGenome

Regulatory-ready AMR safety characterization for live biotherapeutic products and probiotics. FDA and EFSA mandate AMR characterization as a non-discretionary CMC requirement for every IND and BLA.

Capabilities

Broad biosafety characterization from WGS data — virulence factors, toxin systems, and secretion systems
Distinguishes chromosomal from mobile transferable resistance genes
Covers FDA and EFSA regulatory frameworks in one workflow
Generates regulatory-ready CMC submission documentation

Target users

Live biotherapeutic product (LBP) and probiotic developers
Microbiome CDMOs
Agricultural microorganism and biocontrol product developers
Animal health and veterinary product manufacturers

FDA Guidance for Industry: LBPs (2023) · EFSA guidance on AMR in food-chain microorganisms

Work with BengiBio

We are actively engaging clinical and biotherapeutic partners

Whether you run a clinical microbiology lab, lead AMR stewardship, or are developing an LBP — contact us to discuss your needs.

✉ Email info@bengibio.com ⬤ Website bengibio.com