What methods were used as a reference for the SenSATIVAx® and PathoSEEK® manufacturer's validation?

Our validation references guidelines for food and environmental testing from the USP, FDA, and the AOAC.

We released the first version of our SenSATIVAx® and PathoSEEK® Manufacturers Validation Document in 2017.  At the time, there were no official guidelines available from any regulatory body describing how to validate a method for detecting microbes in the presence of a cannabis matrix. 

At that time, our scientific team referenced guidelines for food and environmental testing put forth by the USP, FDA, and AOAC Appendix J.

We continually add data to this document as we release new assays or make improvements to exisiting assays. 

In 2019, the AOAC developed Standard Method Performance Requirements (SMPR) for Aspergillus, E.coli, and Salmonella detection on cannabis. These are three separate SMPRs. There is a draft SMPR for STEC. There is an ongoing ERV (Emergency Response Validation) for Total Yeast and Mold that began in the fall of 2020.  MGC is one of the manufacturers participating in this study.  The AOAC has plans for a complete Total Yeast and Mold SMPR on cannabis, among others, later in 2021.  

Medicinal Genomics is an active member of AOAC’s Cannabis Analytical Science Program (CASP) Microbial Contaminants Working Group. The goal and objectives of this working group are the following:

  • Develop SMPRs for cannabis and hemp

  • Extend a Call for Methods for each of the completed SMPRs

  • Impanel an Expert Review Panel to review candidate methods 

  • Deliver consensus-based First Action and Final Action Official Methods for the cannabis industry

Please download our SenSATIVAs® and PathoSEEK® manufacturer's validation document here: https://www.medicinalgenomics.com/validation-documents/