Independently validated PathoSEEK® qPCR assays show USP <2022> equivalency, cutting microbial testing from up to five days to next day
BEVERLY, Mass.–(BUSINESS WIRE)–#DietarySupplements—Medicinal Genomics today launched a rapid microbial testing solution for dietary supplement manufacturers that delivers next-day pathogen results, compared with the three to five days typical of USP <2022> culture methods. The solution includes three PathoSEEK® multiplex qPCR assays, paired with the MaGiC™ Lysis Kit, to detect Salmonella, Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa.
Microbiology testing is often the slowest step before batch release, and that delay matters more as the market shifts. Gummies, powders and liquids now make up more than half of U.S. supplement sales, according to Nutrition Business Journal, and a recent Salmonella outbreak linked to a greens powder sickened at least 45 people in 21 states, according to the CDC. With the Medicinal Genomics workflow, samples enrich overnight and run on qPCR the next morning, with results that same day.
“For more than a decade, cannabis labs have trusted PathoSEEK to detect pathogens in complex plant-based products under regulations that demand validated methods,” said Brendan McKernan, CEO of Medicinal Genomics. “Supplements were a logical next step. We know these organisms. We know these matrices. And we have the data to prove it. Independent studies now show our assays match USP plating, with results the next day instead of the next week.”
What do the assays detect?
- PathoSEEK® Salmonella, E. coli, and Staph Multiplex detects the USP <2022> specified organisms common in finished-product specifications under 21 CFR Part 111.
- PathoSEEK® Staph & Pseudomonas Multiplex adds Pseudomonas aeruginosa, a concern in water-containing and lipid-based formats such as liquids, gummies and oils.
- PathoSEEK® Salmonella & E. coli Multiplex offers a simplified option for labs and manufacturers whose specifications require only those two organisms.
How were they validated?
All three assays were evaluated in USP <1223> alternative method equivalency studies against USP <2022> plating, conducted by an independent third-party laboratory across five supplement matrices: energy shot, vitamin gummy, vitamin powder, botanical powder and MCT oil, plus chocolate for the Salmonella and E. coli assays. The assays met acceptance criteria for all six USP <1223> validation parameters, including specificity, limit of detection and equivalency.
The Salmonella, E. coli, and Staph Multiplex and the Salmonella & E. coli Multiplex matched plating on 100% of samples, with no false positives or false negatives and single-cell sensitivity (LOD50 of 0.18–0.38 CFU per test portion). The Staph & Pseudomonas Multiplex agreed with plating on 99% of results with no false positives. Results were consistent across two independent analysts, manual and automated extraction, and two qPCR platforms, the Bio Molecular Systems Mic and the Bio-Rad CFX Opus.
How does the workflow run?
Configurations scale from manual to fully automated. MaGiC™ Lysis isolates DNA three times faster than bead-based purification, and the Mic qPCR cycler returns results in under two hours. In the automated workflow, the Myra Liquid Handling System prepares 46 samples in under 15 minutes, with one manual pipette transfer per sample. Together, Mic and Myra fit in under two square feet of bench space.
Availability
All three assays are available now. Learn more about rapid dietary supplement pathogen testing at medicinalgenomics.com/supplements.
About Medicinal Genomics
Medicinal Genomics is a molecular diagnostics company that develops PathoSEEK® qPCR assays and automated workflows for microbial testing in regulated industries. Having built its platform in cannabis and hemp testing, the company now serves dietary supplement and natural products manufacturers operating under 21 CFR Part 111 and USP requirements. Learn more at medicinalgenomics.com.
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Mic and Myra are trademarks of Bio Molecular Systems Pty Ltd. Bio-Rad and CFX Opus are trademarks of Bio-Rad Laboratories, Inc. All other trademarks are the property of their respective owners.
Contacts
Media Contact
Ben Amirault | [email protected] | 866-574-3582
