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DNA-Based Microbial Testing Needed Now for Exacting Compliance

With the growth trajectory in the cannabis, and the need for more exacting compliance about what is inside or clinging to the plant, there is a need to move to DNA-based testing into the industry for methodologies to identify contamination by microbes that are harmful to humans (pathogens).

If this type of testing is not done, the industry will suffer the same challenges the federally regulated food and agriculture industries have been plagued with regarding food safety regulations, with nearly daily outbreaks for decades.

For the better part of a century, the food and agriculture industries have relied on the contamination testing of food and agriculture products using the “old world” microbiological plating methods, commonly known as petri dish testing.

Plating methods are inaccurate, extremely time consuming, and not always able to identify the pathogen(s) that is/are a threat.  For example, differentiating at the species level can be challenging between fungi aspergillus flavus, aspergillus fumigatus, and aspergillus niger against other fungal background.  Aspergillus flavus and niger were both specifically referenced in California’s medical testing regulations (section 19344, subsection 5316 – Microbial  impurities) as fungi for which a lab must test.

Aspergillus is a genus of mold (type of fungus) that causes aspergillosis and is very common both indoors and outdoors, so exposure to these fungal spores is very common.

According to the California Bureau of Marijuana Control Code of Regulations, testing is required for all medical cannabis goods intended for consumption by inhalation, such as dried flower, kief, hashish, oil, and waxes. When inhaled, each of the aspergillus species are known to cause a variety of lung disorders, ranging from asthma, allergic bronchopulmonary aspergillosis, and hypersensitivity pneumonitis to invasive systemic fungal infections in immunocompromised hosts (people with weakened immune systems). The association between cannabis use and invasive and allergic pulmonary aspergillosis has been documented in a number of clinical cases.

One alternative is a DNA-based technology – a fast way of detecting pathogens that is mandated by regulatory agencies.

Regardless of the level of regulatory oversight, the current plating methods are simply not able to meet the needs of the industry. Why? Because by the time a testing lab has identified what is contaminating the source, that contaminant has already spread throughout the supply chain.  Plating methods simply take too long, costly when considering the additional time, and are highly variable.

Plating methods require enrichment in liquid culture medium followed by culturing the collected samples for days, and then visually counting colonies of the pathogens. By the time a lab technician obtains the result, the patient may have already consumed contaminated product, putting their health at risk, or, alternatively, the product is unable to be released for sale which can significantly reduce its effective shelf life.

The classic example of where this type of methodology would have helped in terms of tracing an outbreak earlier would have been Chipotle’s E. coli’s outbreak in early 2016.

There are now new testing devices that can target genetic sequence specific for multiple microbial human pathogens, and deliver test results within six hours from raw sample to data.

With plate culturing, growth rates of these organisms takes days to form detectable colonies, with results in 2-5 days.

Because most states testing regulations have been based off plate culturing in terms of viable cells that is measured in colony forming units (CFUs), the industry has become dependent on this outdated method. And what is extremely concerning is that this method can be “gamed” by any food processing or cannabis industry.

Certain states are allowing growers to sterilize or irradiate their crop, and the corresponding samples, prior to testing.  What this does is “zaps” the viable cells, and puts these cells in a dormant stage. It can potentially kill off the viable pathogenic colonies, but that result is not confirmed.

There is quite a bit of evidence that the presence of microbes on a plant may be stressed due to lack of water and/or nutrients which can cause them to go into a dormant state and may not be easily resuscitated using standard culture techniques. At any point these dormant microbes can become viable, as well as non-culturable – meaning plate culturing methods will not be able to detect or quantify them. This still represents a health risk to the patient and consumer.

DNA testing will factor in both live and dead cells, and the technology cannot be gamed, ensuring patient safety is not compromised.

With the application of new testing technology tethered to an agile tracking system, the cannabis sector will be able to intercept where pathogens and contamination growth is entering the supply chain.

The environmental screening technology does this by detecting contaminant growth of ancillary/mechanical surfaces within internal growers/cultivator houses, providing the real-time data to know which locations to clean, and thus prevent the contamination of the crop.

This can help the industry with traceability of each sample to ensure safety and efficacy, transparency of results for regulators, and with spectral pathogen data profiles across the full supply chain, drive growers, processors and producers to improve internal standard operating procedures (SOPs) and good manufacturing practices (GMPs).

Using DNA-based testing will fundamentally change how the cannabis industry does testing, and help implement a highly transparent and traceable model that will set the industry apart from the food and agriculture world – which today is having to react to outbreaks upon outbreaks, and still chase regulatory compliance through old world technologies and methods.

Milan Patel

Milan Patel

Milan Patel is the chief executive officer and co-founder of PathogenDx. He has over 30 years of experience with large public, to small private and entrepreneurial companies in numerous industries from life sciences, biotechnology, government services, and automotive. Previously, Patel was COO/CFO of GMSbiotech. Patel has worked with Fortune 50 companies in a variety of roles from product and technology development, sales and marketing, finance and manufacturing. Patel has extensive experience in corporate finance, mergers and acquisitions, business strategy and planning, infrastructure and organizational development, and controls, compliance and audit.
He holds degrees in Bachelor of Science in Electrical Engineering from the University of Detroit, a Masters in Biomedical Engineering from the University of Michigan, and a Masters in Business Administration from University of Detroit. Milan co-founded PathogenDx on the premise of bringing a better, faster and more cost-effective solution for purity assurance to the cannabis, food, agriculture and water testing industries.

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