Medicinal Genomics (Beverly, MA) has 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 Centers for Disease Control and Prevention (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 (U.S. Pharmacopeia) plating, with results the next day instead of the next week.”

The assays detect:

• PathoSEEK Salmonella,  coli and Staph Multiplex detects the USP <2022> specified organisms common in finished-product specifications under 21 CFR Part 111.
• PathoSEEK Staph & PseudomonasMultiplex adds Pseudomonas aeruginosa, a concern in water-containing and lipid-based formats, such as liquids, gummies and oils.
• PathoSEEK Salmonella&  coli Multiplex offers a simplified option for labs and manufacturers whose specifications require only those two organisms.

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 percent 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 percent 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.

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 2 square feet of bench space.

For more information, visit https://medicinalgenomics.com/supplements/.