AOAC CASP Meeting

MICROBIAL METHOD ACCEPTANCE, VERIFICATION AND VALIDATION

Problem (Growing Pains) • From state to state we are told different standards that will constitute method verification in line with regulations. • In addition, when a lab does turn in a verification, it is usually returned with improvements that need to be made from regulator to regulator. • Overall, there is such growth and speed in this industry that state regulators seem to be struggling to keep up and provide consistent guidance to testing labs. Causes of Problem Possible Solutions Improved State Oversight • Regulators and cannabis scientists working together to agree on best practices • Regulators could take specific stands on areas of variability within cannabis testing • This should be evidence based when available Lack of standard methods and preparation variability • Industry organizations working together to set standard methods that will comply with all developed assays • Helps to limit variability from lab to lab • Storage conditions • Consistent methods and materials to benchmark to more established methods Lack of Appropriate Standards • Once appropriate standards are created it will be a lot easier to compare assays and laboratories Lack of Proper Training and Human Error • Education…

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PathogenDx | Proprietary andConfidential 2019

MICROBIAL AND MOLECULAR EDUCATION AND TRAINING

Problem • Microbiology testing has not been taken seriously in the cannabis industry until recently • Laboratories are generally run by analytical chemists with little background on microbiology and molecular biology techniques • Laboratory technicians have wide degrees of training and overall limited experience Causes of Problem Possible Solutions Lack of Microbiology Leadership at the Laboratory

• We have been noticing a shift as laboratories hire more PhD level micro and/or molecular biologist – shift as the industry gains more acceptance

Regulators, Labs and Assay Designers Not Working Together

• Work together…

Lack of Proper Training

• Microbial education • We often must train lab users in PCR workflow, assay limitations, challenges with microbiology, even how to use a pipet • Microbial statistics and certainty “greater than” or “estimated” • When to retest and not retest • Proper controls and replicates based on the method being utilized • Training Module: • Statistical sampling and data analysis/ presentation • Reliability and limits of testing • Verification in the laboratory, what is acceptable?

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PathogenDx | Proprietary andConfidential 2019