Microbiome field · LBP developers · IVD · Clinical trials

The genomic analytical capabilities your microbiome program needs — without building them in-house.

Biomarker discovery, qPCR assay design and validation, and clinical trial endpoint support for LBP and probiotic developers. Specialized expertise that typically takes years and significant resources to build internally — available now as a focused service engagement.

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Three core service areas. Currently engaging clients.

We work directly with microbiome researchers, LBP and probiotic developers, and clinical teams who need specialized genomic analytical capabilities that are difficult or impossible to build in-house.

01
Genomic Biomarker Discovery
Turn your sequencing data into prioritized, actionable biomarker candidates — without months of internal computational build-out. We identify and validate genomic signals from WGS, amplicon, and functional genomic datasets that most teams lack the infrastructure to process themselves.
Discovery · Prioritization
What we deliver
  • Candidate biomarker identification from WGS and metagenomic data
  • Strain-level feature analysis and prioritization for diagnostic or monitoring use
  • Cross-cohort signal validation and statistical modeling
  • Biomarker candidate report with analytical rationale and data package
02
qPCR Assay Design & Validation
Bacterial strain characterization and identity documentation are non-negotiable CMC requirements for every IND and BLA — but building validated qPCR assays in-house is a major bottleneck for most programs. We design, validate, and deliver the full analytical package your submission needs.
Design · Validation · Regulatory docs
What we deliver
  • Primer and probe design with specificity analysis against target genomes
  • Analytical validation: sensitivity, specificity, linearity, precision, LOD/LOQ
  • Strain identity and abundance quantification assay packages
  • ICH M10-aligned and FDA IND-ready validation documentation
03
Clinical Trial Endpoint Support
Regulatory agencies expect analytically validated genomic assays for LBP and probiotic trials — and most sponsors don't have them ready at IND stage. We design and validate the endpoint bioassays your trial needs, with full regulatory documentation from the start.
Clinical trials · LBP · IND/BLA
What we deliver
  • Efficacy and safety endpoint bioassay design and analytical validation
  • Microbiome engraftment and abundance monitoring assays
  • Regulatory-ready analytical method documentation for IND submissions
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We are actively engaging new clients and collaborators

Our team brings deep expertise in microbiome analytics, regulatory CMC, and qPCR assay validation from academic and biopharmaceutical settings. We offer project-based engagements tailored to your program stage — from early discovery to IND-enabling validation.

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Tell us about your program

We work with LBP developers, microbiome CDMOs, CROs, and academic research groups. Reach out to discuss your analytical or regulatory needs.

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

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