Yes. Medicinal Genomics will have AOAC PTM approval for all of its assays for which there is a SMPR for cannabis matrix. We have already received our certificate for SenSATIVAx and Aspergillus, and will have Salmonella and STEC E.coli by Q4.
The Association of Official Analytical Chemists (AOAC) publishes microbiological and chemical standards used globally to promote trade and to facilitate public health and safety. Testing labs trust AOAC-certified testing methods because they have passed a rigorous validation process and results have been repeated in multiple locations. Until recently, there have not been Sample Method Performance Requirements (SMPRs) published for testing on a cannabis matrix.
Medicinal Genomics is a member of the AOAC's Cannabis Analytical Science Program (CASP) working group. We are currently working with the AOAC and other CASP members to be among the first platforms to have an AOAC certification for cannabis testing.
About Cannabis SMPRs
In 2019, the AOAC developed a Standard Method Performance Requirements (SMPR) for Aspergillus, STEC E.coli, and Salmonella detection on cannabis. These are three separate SMPRs. In 2020, the AOAC also launched an Emergency Response Validation project for the enumeration of viable total yeast and mold in dried cannabis flower.
As of December 2020, only one microbial testing technology has completed the AOAC’s Performance Tested Methods (PTM) Program for detecting salmonella on cannabis and hemp flower. A few method developers have followed suit in 2021. You can search all the PTMs on the AOAC website.
For SMPRs relevant to PathoSEEK®, the AOAC has only released a Sample Method Performance Requirement (SMPR) for Aspergillus flavus, fumigatus, niger and terreus (SMPR 2019.001) as well as for for Salmonella (SMPR 2020.002) and pathogenic (STEC) e.coli (SMPR 2020.012).
As of April 2021, Medicinal Genomics is in the process of validating against all available SMPRs and will continue to do so as new SMPRs are introduced. We already have extensive internal manufacturer validations performed on all of our assays and published on our website, but the PTM process demands that data is submitted a certain way and validated by a third party and these projects are underway. The 5 Color Aspergillus assay is AOAC approved for cannabis flower and infused edibles. We are busy adding other matrices for Aspergillus in a future "matrix extension" as well all other currently available SMPRs.
Total Yeast and Mold Draft SMPR
There is a draft SMPR for viable Total Yeast and Mold Count (TYM) enumeration currently in a review period. We expect this will become an official SMPR before the end of 2021. Click here to view the draft SMPR. Please review our help center articles on the origin of the Emergency Response Validation for TYM as well as the pitfalls of using plating techniques as a baseline for comparing molecular methods to culture based methods.
Beware of false claims
Many method developers market their AOAC certifications for food products as being equivalent for cannabis matrices. They are not. Please visit our blog on this topic for more information and relevant links: Beware of AOAC-Certified Claims for Cannabis Microbial Testing Methods