Developed with dietary supplement manufacturer NOW, GENE-UP PROBIOTIC SPECIES ID identifies 18 commonly used probiotic species in capsules and powders, including Lactobacillus acidophilus, Lacticaseibacillus rhamnosus and Bifidobacterium animalis subspLANN. lactis. The assay is currently available in the US, with a broader global rollout planned.
Speaking independantly to NutraIngredients, Buffy Gard, vice president of Nutiani at Fonterra and a former member of the USP Probiotics Expert Panel, said “For many years, the probiotic industry has lacked practical tools for routine verification of probiotic identity in finished blended products.”
Gard welcomed the development but noted that species verification should not be confused with strain identification.
“While strain-level identification remains the ultimate goal for fully aligning product composition with the clinical evidence supporting probiotic efficacy, rapid and standardized species verification in finished products represents an important step forward.”
Developed with manufacturers in mind
The assay grew out of a collaboration with NOW, which was looking for a faster way to verify species identity in finished multi-strain products.
“One of the greatest challenges facing probiotic manufacturers is the identification of microorganisms in finished products, particularly those containing multiple species or strain formulations,” Maria Mendres, microbiology manager at NOW, told NI.
Mendres said relying on outside laboratories delayed production release and increased holding costs. Moving the testing in-house, she said, allows manufacturers to verify species identity in around 90 minutes while maintaining confidence in product identity and label claims.
According to bioMérieux, the shorter turnaround could also help manufacturers investigate contamination events or formulation issues earlier in production and make release decisions sooner.
Species versus strain
Most clinical evidence supporting probiotics is linked to specific strains rather than species, which is why strain identification remains important when manufacturers want to connect finished products with the published evidence.
Celina To, senior manager of industry access at bioMérieux, said the new assay addresses a different need: routine species verification during manufacturing.
“Species verification should be viewed as one component of a comprehensive quality management program rather than a replacement for strain characterization,” she said.
To said routine species testing can help manufacturers confirm expected probiotic composition, detect unintended species introduced during production and support label verification. Sequencing, she added, remains important for strain characterization, research and root-cause investigations.
Manufacturers often have to balance testing frequency with testing complexity, To said. By simplifying species verification into a standardized PCR workflow, the company aims to make routine identity testing more practical throughout production.
Meeting changing quality expectations
The initial assay covers 18 probiotic species selected in collaboration with NOW and informed by discussions with industry stakeholders, according to bioMérieux. Future additions will be based on customer demand and emerging market needs.
To said interest in rapid molecular testing is being driven by manufacturers looking to strengthen quality programs, alongside increasing expectations around label accuracy from retailers and consumers.
Gard shared that one advantage of the technology is that it makes molecular identification more accessible to laboratories without the resources to develop and validate more complex genetic testing methods independently.
“Advancements like this can serve as a practical and meaningful step toward the greater transparency, quality assurance, and product accountability that consumers, healthcare professionals, and regulators increasingly expect,” she said.
