CHAMP Human Microbiome Profiler is now available in the CosmosID-HUBLearn More

Sequencing ServicesGRAS Genomic Reporting


In the probiotics market, ingredients that have GRAS (generally recognised as safe) designation will be exempt from certain reviews and approvals by the US FDA. As such, Whole Genome Sequencing of bacterial isolates has been an incredibly insightful method to screen probiotic strains for important insights such as:

  • Strain uniqueness for IP – how closely related is your strain to an existing strain on the market?
  • Antimicrobial Resistance Genes (ARG’s)
  • Virulence Factors
  • Plasmids
  • Phages
  • Functional potential
  • 16S gene characterization and qPCR primer discovery

With Whole Genome Sequencing now more affordable than ever before, having the whole genome sequence of your strain is key and can help with discovery, manufacturing, clinical studies as well as, of course, regulatory applications!

In 2021, CosmosID partnered with Spanish microbiome consulting firm, Sandwalk BioVentures, to provide GRAS regulatory genomic reporting for probiotics developers interested in selling to the US market.

Combining our end-to-end microbial genomics infrastructure with Sandwalk’s regulatory expertise, we can offer genomic sequencing and analysis to organizations developing next-generation functional bacterial strains alongside regulatory-compliant safety reports that can be included in GRAS dossiers, which are legally required for new probiotics to enter the US market.

Now, probiotics manufacturers can take advantage of this readily available turnkey solution which can include:

  • DNA Extraction, if applicable
  • Isolate Whole Genome Sequencing (Illumina)
  • Genome Quality Assessment
  • De Novo Genome Assembly
  • Phylogenetic Analysis
  • 16S rRNA Gene Characterization
  • Strain Characterization
  • GRAS Genomic Reporting for dossier insert

If you’re ready to sell your probiotic and want support in this application process, simply submit an enquiry below and we’ll get you started!

Frequently Asked Questions

Are there limitations on the species or strains you would accept?

Providing the organism is BSL-2 or below, CosmosID will accept bacterial isolates in the form of cell pellets or DNA. The strain will then undergo untargeted characterization for detection of any genotypic information that could hinder the application process.

How would we proceed with this service?

A simply 3-way agreement can be coordinated and provided by CosmosID once the project plan is finalized.

How long would this service take?

A range of turnaround options are available for isolate sequencing and primary analysis to expedite the genomic service and generate a preliminary report in as fast as 3-5 business days. Please enquire and consult with our business development team for more details.

We already have sequencing data, can we still proceed with the service?

Absolutely! Once we understand the number of strains you’d like to analyze and establish GRAS reporting for, an agreement will be put in place and a secure data transfer link will be provided to send over your sequencing data.

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