AMR signal variant pathway
Genomic Intelligence · Clinical Software · SaMD

Turning genomic data into
clinical answers.

BengiBio is a genomic intelligence company. We build software that translates whole-genome sequencing data into actionable clinical outputs — from antimicrobial resistance prediction to genomic biomarker discovery and assay validation. Both platforms are designed to meet FDA regulatory requirements from Day 1.

Who we are

A genomic intelligence company built for clinical-grade software

BengiBio develops software platforms that apply machine learning and computational genomic analysis to solve clinical problems that require FDA-grade reliability — problems where an incorrect answer has direct patient or regulatory consequences.

We are not a sequencing company. We are not a laboratory. We are a software company that makes genomic data clinically useful.

Both platforms are currently seeking pilot partners — pharmaceutical sponsors, IVD developers, and clinical researchers — to validate and deploy our software in real clinical workflows.

FDA-first design

Regulatory requirements built in from Day 1 — not retrofitted for compliance after the fact.

Genomic intelligence

Proprietary ML pipelines on WGS, metagenomic, and host genomic data — interpretable and traceable.

Clinical-grade outputs

Uncertainty quantification and full documentation to FDA IVD and bioanalytical validation standards.

Founding team

Regulatory execution meets computational depth — in one founding team.

GMP-validated AI/ML software, built from scratch in regulated pharmaceutical environments — experience the founding team brings directly to BengiBio.

7

IND programs contributed to and led through FDA-approved clinical trials

FDA-approved trials AI/ML in R&D & CMC
Late phase

Hands-on late-phase FDA submission experience. Has built GMP software to 21 CFR Part 11 for manufacturing analytics and process control — in regulated pharmaceutical environments

21 CFR Part 11 GMP software Manufacturing analytics
10+

Years validating nucleic acid assays for FDA-regulated drug development and clinical trials

PCR · qPCR · NGS ICH Q2 · CLSI
Why this team wins.
Regulatory depth, validated software engineering, and nucleic acid assay science — in one founding team. A combination rarely found together, and what makes BengiBio’s outputs trustworthy at FDA level from day one.

Our platforms

Two independent platforms. Two distinct clinical problems.

Each platform is purpose-built for its domain — with its own computational engine, regulatory pathway, and customer base.

WGS · SaMD · FDA De Novo · Biotherapeutic safety
AMR & Safety Intelligence
Machine learning software that converts whole-genome sequencing data into antimicrobial resistance predictions and biotherapeutic safety assessments — designed from Day 1 for FDA clearance.
BengiAI‑AMR · SafetyGenome Explore →
Genomic biomarkers · PCR · qPCR · IVD · Drug development
Genomic Biomarker Discovery & Validation
Computational genomic intelligence for identifying, characterizing, and analytically validating genomic biomarkers — serving IVD developers, pharmaceutical sponsors, and clinical researchers.
Biomarker Discovery & Validation Platform Explore →

Connect with BengiBio

We are actively seeking collaboration

Whether you are a clinician, hospital administrator, diagnostics company, drug developer, or researcher — we want to hear from you.

Email info@bengibio.com Website bengibio.com