Isentio
Pathogenomix is a company dedicated to rapid and accurate pathogen identification using DNA/RNA sequencing technologies. Their solutions, including Ripseq software and databases, enable fast, reliable microbial detection in clinical and environmental samples without the need for extensive bioinformatics resources. They have received FDA Breakthrough Device Designation for their innovative diagnostic tools, aiming to improve infectious disease treatment and microbiological diagnostics.
Industries
Nr. of Employees
small (1-50)
Products
Targeted sequencing analysis service for NGS data
Analysis workflow that preprocesses targeted NGS reads locally to minimize upload, then performs cloud-based taxonomic identification against curated databases and generates reports for clinical/research use.
Sanger sequencing mixed-sample analysis tool
Online application to interpret mixed Sanger chromatograms, perform bulk uploads, apply confidence flags aligned to clinical sequencing guidelines, and generate reports for single and mixed-organism samples.
Targeted NGS clinical assay under regulatory review
A targeted 16S-based NGS assay and accompanying protocols and databases developed for clinical pathogen identification; noted as having received an FDA Breakthrough Device designation and not marketed until regulatory clearance.
Targeted sequencing analysis service for NGS data
Analysis workflow that preprocesses targeted NGS reads locally to minimize upload, then performs cloud-based taxonomic identification against curated databases and generates reports for clinical/research use.
Sanger sequencing mixed-sample analysis tool
Online application to interpret mixed Sanger chromatograms, perform bulk uploads, apply confidence flags aligned to clinical sequencing guidelines, and generate reports for single and mixed-organism samples.
Targeted NGS clinical assay under regulatory review
A targeted 16S-based NGS assay and accompanying protocols and databases developed for clinical pathogen identification; noted as having received an FDA Breakthrough Device designation and not marketed until regulatory clearance.
Services
Browser-accessible software service that ingests Sanger and targeted NGS data, performs preprocessing and taxonomic identification against curated reference databases, and produces automated reports.
Curated marker-gene reference databases with automated filters, taxonomy cross-referencing, and user tools to annotate, approve, or reject references to build medically relevant reference sets.
Laboratory protocols and primer designs for PCR amplification of marker genes used in targeted sequencing workflows (available as downloadable protocols).
Development activities for a targeted NGS clinical assay that has been assigned FDA Breakthrough Device designation; regulatory guidance and data-generation support for submission pathways.
Browser-accessible software service that ingests Sanger and targeted NGS data, performs preprocessing and taxonomic identification against curated reference databases, and produces automated reports.
Curated marker-gene reference databases with automated filters, taxonomy cross-referencing, and user tools to annotate, approve, or reject references to build medically relevant reference sets.
Laboratory protocols and primer designs for PCR amplification of marker genes used in targeted sequencing workflows (available as downloadable protocols).
Development activities for a targeted NGS clinical assay that has been assigned FDA Breakthrough Device designation; regulatory guidance and data-generation support for submission pathways.
Expertise Areas
- Clinical infectious-disease diagnostics
- Targeted metagenomic (amplicon) sequencing
- Polymicrobial sample analysis and mixed-chromatogram interpretation
- Clinical bioinformatics and cloud-based analysis pipelines
Key Technologies
- Targeted amplicon next-generation sequencing (NGS)
- Sanger sequencing analysis
- Long-read sequencing (nanopore) support
- Cloud-based SaaS analytics
News & Updates
Pathogenomix was granted FDA Breakthrough Device Designation for its Patho-Seq assay, which rapidly detects and identifies hundreds of bacteria from clinical samples, significantly advancing infectious disease diagnostics.
The FDA has granted Pathogenomix's Patho-Seq NGS test Breakthrough status, enabling rapid identification of bacteria during dangerous infections such as sepsis and bacterial meningitis.
Pathogenomix was granted FDA Breakthrough Device Designation for its Patho-Seq assay, which rapidly detects and identifies hundreds of bacteria from clinical samples, significantly advancing infectious disease diagnostics.
The FDA has granted Pathogenomix's Patho-Seq NGS test Breakthrough status, enabling rapid identification of bacteria during dangerous infections such as sepsis and bacterial meningitis.