Regulators want whole-genome evidence of where a species already occurs
United States
USDA PPQ field-trial permits must show the strain already exists in the permit jurisdiction, supported by whole-genome species identity. Evidence requirements are shifting away from 16S-based identification.
European Union
EFSA's 2025 guidance calls for whole-genome identification of microbial actives, plant protection products included. In dossiers, evidence that a species already occurs naturally in the receiving environment can strengthen fate-and-behaviour arguments.
Today that evidence comes from manual searches of public databases, with messy metadata, vague locations and outdated names, or from direct environmental sequencing, which is expensive and usually saved for strains that have finished development.
How it works
Preliminary results typically arrive within two weeks of scoping.
Scope
Agree the taxa, target habitats and jurisdictions with our team.
Reference
We compile your genomes, or the best public genomes for each taxon, into a k-mer reference database.
Search
We query a geolocated index of public genomes and shotgun metagenomes at a 95% ANI species threshold.
Report
You receive matches by habitat and jurisdiction, with full methodology, sample accessions and citations.
Who uses TaxaLens
Regulatory teams
Evidence for USDA PPQ permit applications today, and natural-occurrence support for EU dossiers. Companies outside the US use it to prepare for American field trials.
Regulatory consultancies
A specialist evidence module for your clients' microbial files, delivered to your team. Ask about partnering on client dossiers.
R&D and pipeline leads
Screen candidate strains for natural occurrence in your target markets before you commit development budget, including rare taxa with a single published isolation.
Case study: permits approved in four weeks
A multinational ag-biotech's microbial biostimulant programme had its field-trial permits denied late in planning: the existing indigeneity data lacked whole-genome species identity. Years of work by a research group, and CRO trials across the continental US, were at risk.
TaxaLens delivered the evidence entirely in-silico, in time for the CRO planning deadlines, and every permit was approved.
For one taxon with a single published isolation, TaxaLens found 107 species-level matches.
- Project scoped
- Reference database compiled
- Preliminary data to prioritise permitting work
- Full supporting data for most strains
- Final evidence for two extremely rare taxa
What's behind every match
- 2.3 million+ samples
- Public SRA samples indexed, with new samples added monthly.
- 20 metadata fields
- Harmonised per sample, including latitude and longitude.
- 95% ANI threshold
- The species boundary. Every match is reported with a confidence interval.
- Genome coverage estimates
- Detections are reported with coverage estimates to give you the insight you need.
- Accessions and citations
- Each match links to its sample accession, BioProject and any publication describing it.
- Your genomes or public references
- Query with your own genomes to find unpublished relatives, or with the best public genomes for a taxon.
Questions
Do we need to send samples?
No. TaxaLens is entirely in-silico. Share genomes or taxonomic identifiers for your strains and the jurisdictions you care about.
How long does it take?
Preliminary results typically arrive within two weeks of scoping. In the case study above, final evidence for the rarest taxa came in week four.
Can it handle rare or unpublished strains?
Yes. It supports taxa with a single published isolation, and with your genome as the query it also finds related strains never described in the literature.
Does this replace an environmental risk assessment in the EU?
Not for plant protection products. The 2025 EFSA provision for species that are common in the receiving microbiome applies to feed and other food-chain products. For plant protection products, TaxaLens supports whole-genome identity and fate-and-behaviour arguments.
Which geographies are covered?
The United States today. Coverage is expanding to EU member states and Central Africa. Ask for our Northern Spain demo report to see EU results.
Do you work with regulatory consultancies?
Yes. We can support your client dossiers directly. Get in touch to discuss partnering.
Discuss a pilot analysis of your strains
Tell us your strains and target jurisdictions and we'll scope a pilot with you.
Or email info@snthesis.com directly.