Leaders in Hashish Testing – Half 1: A Q&A with Milan Patel, CEO and Co-Founding father of PathogenDx

On this “Leaders in Hashish Testing” collection of articles, Inexperienced interviews hashish testing laboratories and expertise suppliers which might be bringing distinctive views to the trade. Specific consideration is targeted on how these companies combine progressive practices and applied sciences to navigate a quickly altering panorama of regulatory constraints and B2B demand.

PathogenDx is an Arizona-based supplier of microbial testing applied sciences. Since their inception in 2014, they’ve broadened their attain to 26 states within the US. Along with hashish product testing, PathogenDx additionally supplies applied sciences for meals security testing, environmental testing and not too long ago began providing human diagnostics testing to assist COVID-19 response efforts.

We interviewed Milan Patel, CEO and co-founder of PathogenDx. Milan based PathogenDx as a spin-off from one in all his investments in a scientific diagnostics firm testing for genetic markers in transplant organs. Previous to PathogenDx, Milan labored in finance and advertising at Intel and later served as CFO at Acentia (now Maximus Federal).

Aaron Inexperienced: What’s the historical past of PathogenDx?

Milan Patel: PathogenDx was successfully a spin-off of a scientific diagnostics firm that my companion Dr. Mike Hogan, the inventor of the expertise, had based when he was a professor on the College of Arizona, however beforehand at Baylor Medical School again in 2002. I had invested within the firm again then and I had realized that his expertise had a broad and extensive sweeping influence for testing – not only for pathogens in hashish particularly, but additionally for pathogens in meals, agriculture, water and even human diagnostics. Within the final 14 months, this grew to become very private for each single particular person on the planet having been impacted by SARS-CoV-2, the viral pathogen inflicting Covid-19. The genesis of the corporate was simply this, that human well being, meals and agricultural provide, and the setting has and can proceed to be focused by bacterial, fungal and viral pathogens impacting the security and well being of every human on the planet.

We based PathogenDx and we pivoted the corporate from its authentic human organ transplant genetics market scope into the larger markets; we felt the unique focus was too area of interest for a expertise with this a lot potential. We licensed the expertise, and we repurposed it into primarily hashish. We felt that attaining business success and use within the arms of hashish testing labs on the state degree the place hashish was first regulated was essentially the most logical subsequent step. In the end, our objective was and is to maneuver into markets which might be permitted on the federal regulatory aspect of the spectrum, and that’s the place we are actually.

Inexperienced: What yr was that?

Patel: 2014.

Inexperienced: So, PathogenDx began in hashish testing?

Patel: Sure, we began in hashish testing. We now have over 100 labs which might be utilizing the expertise. There’s a particular want in hashish if you’re taking a look at contamination or an infection.

Within the case of contamination on hashish, you have to search for bacterial and fungal organisms that make it unsafe, comparable to E. coli, or Salmonella or Aspergillus pathogens. We’re accustomed to latest points just like the romaine lettuce foodborne sickness outbreaks at Chipotle. Within the case of fungal organisms comparable to Aspergillus, when you smoke or eat contaminated hashish, it might have a huge effect in your well being. Hashish regulators realized that to make sure public well being and security there was greater than only one pathogen – there have been half a dozen of those bugs, at a minimal, that may very well be dangerous to you.

The fantastic thing about our expertise, utilizing a Microarray is that we are able to do what known as a multiplex take a look at, which implies you’re capable of take a look at for all bacterial and fungal pathogens in a single take a look at, versus the outdated “Adam Smith” mannequin, which exams every pathogen on a one-by-one foundation. The normal strategy is expensive, time consuming and cumbersome. Hashish is such a excessive worth crop and producers must get the reply shortly. Our exams may give a end in six hours on the identical day, versus the 2 or three days that it takes for these different permitted strategies available on the market.

Inexperienced: What’s your enterprise mannequin? Is there gear along with consumables?

Patel: Our enterprise mannequin is the basic razor blade mannequin. What which means is we promote gear in addition to the consumables – the testing kits themselves.

The PathogenDx expertise makes use of commonplace, off-the-shelf lab gear that yow will discover anyplace. We didn’t need to make the gear proprietary so {that a} lab has to purchase a particular OEM branded product. They’ll use virtually any gear that’s out there commercially. We needed to make it possible for labs are solely paying a fraction of the associated fee to get our gear, versus utilizing different distributors. Secondly, the platform is open-ended, which means it’s extremely versatile to work with the volumes that totally different hashish labs see day by day, from excessive to low.

One gear set can course of many several types of testing kits. There are kits for regulated testing required by states, in addition to required environmental contamination.

Inexperienced: Do you present any in-house or reference lab testing?

Patel: We do. Now we have a CLIA lab for scientific testing. We did this a few yr in the past after we began doing COVID testing.

We don’t do any type of in-house reference testing for hashish, although we do use particular reference supplies or requirements from Emerald Scientific, for instance, or from NCI. Our platform is all externally third-party reference lab examined whether or not it’s validated by our exterior hashish lab clients or an unbiased lab. We wish our clients to make it possible for the precise take a look at works in their very own arms, in their very own facility by their very own individuals, versus simply shrugging our shoulders and saying, “hey, we’ve performed it ourselves, imagine us.” That’s the distinction.

Inexperienced: Are you able to clarify the distinction between qPCR and endpoint PCR?

Patel: The distinction between PathogenDx’s Microarray is it makes use of endpoint PCR versus qPCR (quantitative actual time PCR). Successfully, our take a look at doesn’t have to be enriched. Endpoint PCR delivers the next degree of accuracy, as a result of when it goes to amplify that focus on DNA, whether or not it’s E. coli, Salmonella or Aspergillus items, it makes use of all of the primer reagent to its endpoint. So, it amplifies each single piece of an E. Coli (for instance) in that pattern till the primer is totally consumed. Within the case of qPCR, it mainly reaches a threshold after which the response stops. That’s the distinction which ends up in a a lot larger degree of accuracy. This supplies virtually 10 occasions larger sensitivity to establish the pathogen in that pattern.

The second factor is that we’ve separated out how the amplified pattern hybridizes to the probe. Within the case of our assay, we’ve a microarray with a effectively in it and we printed the precise probe that has the sequence of E. coli in there, now driving 100% specificity. Whereas within the qPCR, the response isn’t solely amplifying, however it’s additionally mainly working with the probe. So, in that approach, we’ve the next degree of effectivity by way of specificity. You get a particular reply precisely by way of the organism you’re searching for.

By way of an analogy, let’s take a zipper code for instance which has the additional 4 digits on the finish of it.  Within the case of endpoint PCR, we’ve 9 digits. Now we have our primer probes which signify the usual 5 digits of a zipper code, and the bodily location of the probe itself within the effectively which serves as the additional 4 digits of that zip code. The analyte should match each major and secondary components of the nine-digit zip code for it to lock in, like a key and a lock. And that’s the best way our expertise works in a nutshell.

Endpoint PCR is totally totally different. It drives larger ranges of accuracy and specificity whereas decreasing the turnaround time in comparison with qPCR – down to 6 hours from pattern to consequence. In qPCR, you have to enrich the pattern for twenty-four to 48 hours, relying on micro organism or fungus, after which amplification and PCR evaluation might be performed in a single to a few hours. The accuracies and the turnaround occasions are the most important variations between the endpoint PCR and qPCR.

Inexperienced: If I perceive appropriately, it’s a printed microarray within the effectively plate?

Patel: That’s right. It’s a 96-well plate, and in every effectively, you’ve now printed all of the probes for all targets in a single effectively. So, you’re not operating a couple of effectively per goal, or per organism like you might be for qPCR. You’re operating only one effectively for all organisms. With our effectively plates, you’re consuming fewer wells and our patented foil-cover, you solely use the wells you want. The unused wells within the effectively plate can be utilized in future exams, saving on prices and labor.

Inexperienced: Do you’ve another differentiating IP?

Patel: The multiplex is the core IP. The way in which we course of the uncooked pattern, whether or not it’s flower or non-flower, with out the necessity for enrichment is one other a part of the core IP. We do triplicate probes in every effectively for E. Coli, triplicate probes for Salmonella, and so forth., so there are three probes per focused organism in every of the wells. We’re triple checking that you simply’re definitively figuring out that bug on the finish of the day. That is the cornerstone of our expertise.

We had been simply permitted by the State of New York, and the New York Division of Well being has 13 totally different organisms for testing on hashish. Give it some thought: one of the vital rigorous testing necessities at a state degree – possibly even at a federal degree – and we simply bought permitted for that. In the event you needed to do 13 organisms individually, whether or not it’s plate tradition or qPCR, it will grow to be tremendous costly and really troublesome. It could break the very backs of each testing lab to do this. That’s the place the multiplexing turns into tremendously useful as a result of what you’re doing is leveraging the flexibility to do every part as a single take a look at and single response.

Inexperienced: You talked about New York. What different geographies are you energetic in?

Patel: We’re energetic in 26 totally different states together with the most important hashish gamers: Florida, Nevada, California, Arizona, Michigan, New York, Oklahoma, Colorado and Washington – and we’re additionally in Canada. We’re at present working to enter different markets, however it all comes right down to navigating the regulatory course of and getting approval.

We’re not energetic at present in different worldwide markets but. We’re at present going by the AOAC approval course of for our expertise and I’m blissful to say that we’re near getting that within the subsequent couple of months. Past that, I feel we’ll scale extra internationally.

I’m delighted to say that we additionally bought FDA EUA federal degree authorization of our expertise which drives vital credibility and confidence for the usage of the expertise. A couple of yr in the past, we made a aware option to make this expertise federally acceptable by going into the COVID testing market. We bought the FDA EUA again on April 20, paradoxically. That vote of confidence by the FDA signifies that our expertise is able to human testing. That has helped to create some runway by way of getting federalized with each the FDA and the USDA, and certification by AOAC for our totally different exams.

Inexperienced: Was that COVID-19 EUA for scientific diagnostics or surveillance?

Patel: It was for scientific diagnostics, so it’s an precise human diagnostic take a look at.

Inexperienced: Final couple of questions right here. As soon as you discover one thing as a hashish operator, whether or not its micro organism or fungus, what are you able to do?

Patel: There are lots of providers which might be tied into our ecosystem. For instance, we work with Willow Industries, who does remediation.

There’s been a number of criticism round DNA primarily based expertise. It doesn’t matter if it’s qPCR or endpoint PCR. They are saying, “effectively, you’re additionally together with useless organisms, useless DNA.” We do have a element of separating reside versus useless DNA with a biomechanical course of, utilizing an enzyme that we’ve created, and it’s out there commercially. Labs can take a look at for whether or not a pathogen resides or useless and, in lots of circumstances, once they discover it, they will companion with remediation corporations to assist tackle the difficulty on the grower degree.

One other product we provide is an EnviroX take a look at, which is an environmental take a look at of air and surfaces. These have 50 pathogens in a single effectively. Take into consideration this: these are all of the unhealthy actors that sometimes develop the place soil is – the human pathogens, plant pathogens, powdery mildew, Botrytis, Fusarium – these are very problematic for the 1000’s of growers on the market. The concept is to assist them with screening expertise earlier than samples are pulled off the cover and go to a regulated lab. We can assist the growers isolate the place that contamination is in that facility, then the remediation corporations can are available in, and assist them save their crop and keep away from financial losses.

Inexperienced: What are you most inquisitive about studying about?

Patel: I would like that the hashish trade not undergo the identical errors different industries have gone by. Hashish began as a cottage trade. It’s clearly doubled yearly, and because it will get scaled, the massive companies are available in. Sophistication, requirements, maturity all assist in legitimacy of a enterprise and picture of an trade. On the finish of the day, we’ve a possibility to be taught from different industries to essentially leapfrog and never need to undergo the identical errors. That’s one of many issues that’s vital to me. I’m very captivated with it.

One factor that I’ll depart you with is that this: we’re coping with extra bugs in hashish than the meals trade. The meals trade is barely coping with two to 4 bugs and take a look at the variety of recollects they’re navigating – and this can be a multi-billion-dollar trade. Hashish continues to be a fraction of that and we’re coping with extra bugs. We need to look forward and keep away from these recollects. How do you keep away from a number of the challenges round antimicrobial resistance and antibiotic resistance? We don’t need to be taking place that highway if we are able to keep away from it and that’s type of a private mission for myself and the corporate.

Hashish itself is so highly effective, each medicinally in addition to recreationally, and it may be useful for each customers and trade picture if we do the suitable issues, and keep away from future disasters, just like the vaping disaster we went by 18 months in the past due to unhealthy GMPs. We should be taught from these industries. We’re making an attempt to make it higher for the suitable causes and that’s what’s vital to me.

Inexperienced: Okay, nice. That concludes the interview. Thanks, Milan.

Patel: Thanks for permitting me to share my ideas and your time, Aaron.