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!