Medicinal Genomics Launches Rapid Pathogen Testing Solution for Dietary Supplement Manufacturers
Medicinal Genomics has launched a rapid microbial testing solution designed to help dietary supplement manufacturers identify key foodborne and opportunistic pathogens faster than conventional culture-based testing methods. The new offering combines three PathoSEEK® multiplex quantitative polymerase chain reaction (qPCR) assays with the MaGiC™ Lysis Kit, enabling laboratories to detect Salmonella, Escherichia coli (E. coli), Staphylococcus aureus and Pseudomonas aeruginosa with results available the next day.
The company said the workflow can significantly shorten the time required for microbial testing compared with the three to five days typically associated with United States Pharmacopeia (USP) Chapter culture methods. By enabling overnight sample enrichment followed by qPCR testing the following morning, the system can provide results on the same day as the molecular testing process.
Microbiological testing is frequently one of the longest stages in the dietary supplement manufacturing process, particularly when finished products must undergo testing before they can be released for distribution. Medicinal Genomics’ new solution aims to help manufacturers reduce these delays while maintaining testing performance and supporting product quality and safety programs.
The launch comes as the dietary supplement industry continues to expand its product offerings, with gummies, powders and liquids accounting for more than half of U.S. supplement sales, according to Nutrition Business Journal. These diverse formulations can create different challenges for microbiological analysis, increasing the importance of testing methods that can accommodate complex product matrices.
Food safety concerns have also reinforced the need for effective pathogen detection. According to the U.S. Centers for Disease Control and Prevention (CDC), a recent Salmonella outbreak associated with a greens powder sickened at least 45 people across 21 states. Such incidents highlight the importance of reliable microbial testing as manufacturers seek to identify potential contamination before products reach consumers.
Expanding PathoSEEK Technology Into Dietary Supplements
Medicinal Genomics has developed its PathoSEEK platform for pathogen detection in complex plant-based products, with more than a decade of experience supporting cannabis laboratories. The company is now applying that expertise to the dietary supplement market, where manufacturers must address microbial risks across an increasingly diverse range of formulations.
Brendan McKernan, CEO of Medicinal Genomics, said the supplement sector represents a natural extension of the company’s established pathogen-testing capabilities.
“For more than a decade, cannabis labs have trusted PathoSEEK to detect pathogens in complex plant-based products under regulations that demand validated methods,” McKernan said. “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.”
The company designed the new offering to address different testing requirements rather than provide a single configuration for every manufacturer. Its three multiplex qPCR assays target different combinations of microorganisms, allowing laboratories to select the option that best aligns with their finished-product specifications and testing needs.
Multiplex qPCR technology enables multiple targets to be assessed within a single testing workflow. This approach can help laboratories streamline routine analysis by reducing the need to conduct separate tests for every organism included in a product’s microbial testing requirements.
The accompanying MaGiC Lysis Kit is intended to simplify DNA preparation, helping laboratories move from sample processing to molecular detection more efficiently.
Three Assays Address Different Pathogen Testing Requirements
The Medicinal Genomics launch includes three PathoSEEK assays, each designed to support a different combination of microbial targets.
PathoSEEK® Salmonella, E. coli, and Staph Multiplex
The first assay detects Salmonella, E. coli and Staphylococcus aureus. These organisms are relevant to microbial testing programs for dietary supplements, and the assay is designed to support finished-product specifications aligned with USP Chapter and applicable requirements under 21 CFR Part 111.
Part 111 establishes current good manufacturing practice requirements for dietary supplements in the United States. Manufacturers must maintain appropriate quality controls to help ensure that their products meet established specifications, including applicable requirements for identity, purity, strength, composition and limits on contaminants.
For laboratories testing products against specifications that include these organisms, the multiplex assay provides a consolidated molecular testing option.
PathoSEEK® Staph & Pseudomonas Multiplex
The second assay detects Staphylococcus aureus and Pseudomonas aeruginosa. Medicinal Genomics highlighted P. aeruginosa as a particular consideration for water-containing and lipid-based product formats, including liquids, gummies and oils.
The inclusion of this organism expands the testing options available to manufacturers working with formulations that may have specific microbiological risks or additional testing requirements. By combining both targets in one assay, the solution is intended to support laboratories seeking a more streamlined approach to their testing workflows.
PathoSEEK® Salmonella & E. coli Multiplex
The third assay detects Salmonella and E. coli. It is intended for laboratories and manufacturers whose product specifications require testing for these two organisms without the additional targets included in the other multiplex configurations.
This option allows manufacturers to match their testing approach to their particular product requirements, potentially avoiding unnecessary testing complexity when a narrower pathogen panel is appropriate.
Together, the three assays offer flexibility for laboratories working across different supplement categories and finished-product specifications.
Independent Validation Compared With USP Culture Methods
Medicinal Genomics reported that all three assays underwent alternative-method equivalency studies conducted in accordance with USP Chapter . The studies compared the molecular assays with conventional plating methods described in USP Chapter .
An independent third-party laboratory evaluated the assays across multiple supplement matrices to assess their performance in representative product types. The validation covered five primary matrices: energy shots, vitamin gummies, vitamin powders, botanical powders and medium-chain triglyceride (MCT) oil. Chocolate was also included in the studies for the Salmonella and E. coli assays.
Testing across different matrices is important because supplement ingredients and formulations can affect sample preparation and microbial detection. A method that performs well in one product category may require additional evaluation before it can be applied to other formulations. The study design therefore assessed performance across a range of representative products rather than relying on a single sample type.
According to Medicinal Genomics, all three assays met the acceptance criteria for all six USP validation parameters, including specificity, limit of detection and equivalency.
The results varied slightly by assay.
The PathoSEEK Salmonella, E. coli, and Staph Multiplex and the PathoSEEK Salmonella & E. coli Multiplex matched the results obtained through conventional plating in 100% of samples evaluated. The company reported no false-positive or false-negative results for these two assays.
Both also demonstrated single-cell sensitivity, with a reported median limit of detection, or LOD50, ranging from 0.18 to 0.38 colony-forming units (CFU) per test portion.
The PathoSEEK Staph & Pseudomonas Multiplex agreed with conventional plating in 99% of results and produced no false-positive results, according to the company.
These findings support Medicinal Genomics’ claim that its molecular assays can provide testing performance comparable to the reference culture-based method while substantially shortening the time needed to obtain results.
The company also reported that performance remained consistent across two independent analysts, manual and automated DNA extraction methods, and two qPCR platforms: the Bio Molecular Systems Mic and the Bio-Rad CFX Opus.
Consistency across analysts, extraction configurations and instruments can be important for laboratories seeking to incorporate a method into routine operations. It can also help laboratories evaluate whether a workflow is suitable for their existing equipment and staffing arrangements.
The reported results reflect the company’s description of its validation studies. Individual manufacturers and laboratories will still need to determine how the assays fit their own product specifications, quality systems and applicable testing requirements.
Faster Sample Preparation and Molecular Detection
In addition to reducing testing time, Medicinal Genomics said the solution is designed to accommodate laboratories with different levels of automation.
The workflow begins with sample enrichment, which takes place overnight. Samples are then processed for molecular analysis, with qPCR testing performed the following morning. Results can be available that same day, reducing the waiting period associated with conventional culture methods.
The MaGiC Lysis Kit is a central component of the workflow. According to Medicinal Genomics, its DNA isolation process is three times faster than bead-based purification. Faster DNA preparation can help laboratories reduce the time between sample enrichment and the start of molecular testing.
The company also uses the Mic qPCR cycler, which returns results in less than two hours. The instrument’s analysis time is intended to support rapid turnaround after sample preparation is complete.
For laboratories seeking greater automation, the workflow can incorporate the Myra Liquid Handling System. Medicinal Genomics said Myra can prepare 46 samples in less than 15 minutes, with one manual pipette transfer required per sample.
This configuration is designed to reduce repetitive laboratory work while maintaining a relatively compact equipment footprint. Together, the Mic and Myra systems occupy less than two square feet of bench space, according to the company.
The availability of manual and automated configurations may make the solution relevant to laboratories with different sample volumes, staffing resources and facility constraints. Smaller laboratories may prefer a manual setup, while higher-throughput operations could benefit from automated sample preparation.
Supporting Faster Batch Release and Manufacturing Efficiency
Microbial testing turnaround can affect several stages of dietary supplement production. Manufacturers may need to wait for test results before releasing finished products, meaning delays in laboratory analysis can influence inventory management, production schedules and distribution timelines.
Reducing the time needed to obtain results could help manufacturers make batch-release decisions sooner, provided the testing process satisfies their quality requirements and applicable regulations.
Faster testing may be particularly relevant to manufacturers producing gummies, powders, oils and liquids, which represent a substantial portion of the U.S. supplement market. As product formats diversify, laboratories may need flexible testing methods that can accommodate multiple matrices without creating unnecessary delays.
However, a faster analytical result does not eliminate the need for appropriate sampling, enrichment, validated procedures, quality controls or documented review. Manufacturers must ensure that their testing programs remain aligned with their product specifications and regulatory obligations.
Medicinal Genomics is positioning its new assays as an alternative to slower culture-based approaches, with the goal of combining validated microbial detection with a more efficient operational workflow.
Assays Available Now
Medicinal Genomics confirmed that all three PathoSEEK multiplex qPCR assays are available now for dietary supplement manufacturers and testing laboratories.
The offering combines pathogen-specific detection panels, the MaGiC Lysis Kit and compatible qPCR and liquid-handling systems. Depending on the configuration selected, laboratories can use manual processing or incorporate automation to support higher sample throughput.
The launch extends Medicinal Genomics’ pathogen-testing technology beyond cannabis testing and into the broader dietary supplement sector. By targeting Salmonella, E. coli, Staphylococcus aureus and Pseudomonas aeruginosa, the company aims to help manufacturers address important microbial testing needs while reducing turnaround times.
Additional information about the assays and the rapid dietary supplement pathogen-testing workflow is available at medicinalgenomics.com/supplements.
With next-day testing results, independent equivalency-study data and flexible workflow configurations, Medicinal Genomics is seeking to give supplement manufacturers and laboratories another option for integrating microbial testing into production and quality-control operations.
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.