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Can we disrupt (in a good way) the way we diagnosis infectious diseases like flu, multidrug-resistant TB, sexually transmitted infections and more?

Dr. David Persing, MD, PhD, is a renowned scientist, physician, and chief medical and technology officer of Cepheid (recall they were the folks who helped us make this ridiculously amazing old skool flu rap video). He was kind enough to visit Studio Z to share some of what he’s learned on the front lines of translating bench science (from the earliest days of PCR, SPOILER ALERT: OJ’s lawyers actually called him up as an expert) to the trenches of managing ebola and MDR TB in the developing world…to right here at home with STIs and influenza. I came away from the discussion inspired that we can help us build Health 3.0 by truly personalizing medicine while simultaneously making our lives as patients and caregivers that much easier. 

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– All right, everybody. We are here today with a really, really special guest I’m super excited about. He is the Chief Medical Officer and Chief Technology Officer for Cepheid. He is an MD/PhD from my institution, UCSF. Everybody please welcome Dr. Dave Persing.

– Thank you, Z. It’s a pleasure to be here.

– Man, thank you for being with us.

– I have been a fan of yours for a long time.

– That is very concerning because you’re extremely smart, which makes me think there’s a component of delusion.

– Yeah, but I have this typical pathologist’s sense of droll humor and I really appreciate what you’ve done.

– So you’re trained in pathology, the MD part at UCSF, which is where I went; grim, dark place, lots of fog.

– Yes.

– And you lived in married student housing.

– [Dave] I did.

– That was up on the hill where it was rainy all the time.

– Yup, Mt. Sutro Tower, with the big tower up there and the eucalyptus trees that would catch the fog and drip on my car and dissolve the paint on my car, but it, you know, it was okay, and it was survivable. We enjoyed it and UCSF was a great place to train.

– Now you, the thing is you were there during the kind of early golden age of genetics–

– Right.

– And PCR and, tell us a little about that because it’s fascinating to me how much this has changed and I think that’s really what this show is about is how we’ve disrupted this technology of genetics, made it something you can do very much more quickly, easier, less expensive, and more accurately than ever before and how that’s gonna transform care for our patients.

– Yeah. So, in every few decades there comes along a technology that’s transformative. Right now all the talk is CRISPR, you know, the gene replacement technology, gene editing technology.

– By the way, we’ve edited Logan’s genes in the back so he’s 70% more ripped.

– Okay.

– So it’s after the fact, it’s a somatic line mutation. It doesn’t work that way, does it?

– So he’s CRISPR. Way, way CRISPR.

-That’s exactly what he is. Thank you for that. I’m sorry I interrupted you.

– But back then, in the mid-80s and late-80s it was PCR. PCR stands for polymerase chain reaction. It was a way of zeroing in on a segment of nucleic acid and amplifying it over a matter of minutes to trillions plus copies. And that made it possible to really go after tiny amounts of genetic material and create a system that would allow you to identify that material very quickly.

– And, you know, essentially, ’cause in my earliest memories of genetics I did a honor’s thesis in the lab of Jim Fristrom at Berkeley on drosophila genetics. We were looking for interim mutations and so that was my earliest memory of it, apart from learning in college. But I remember in medical school, it started to hit the public eye when the OJ trial was happening and they were talking about DNA testing and is it accurate. Do you remember that?

– Yeah, actually. Let me just step back a little bit. Okay? So, I heard about PCR when I was doing tissue culture in the lab of Harold Varmus and Don Ganem.

– Whoa, whoa, whoa. Harold Varmus and Don Ganem?

– Harold Varmus, yes.

– Those are huge names.

– Yeah, so I did my thesis, PhD thesis in genetics with him and I was in the lab, doing my stuff as a grad student, doing tissue culture, and I hear this report on NPR about this new technology called polymerase chain reaction and how it was gonna have this big impact on medicine. And here I am, toiling away, trying to get my cells to grow and I hear this and I’m finishing up my training in grad school, about to finish off medical school after that, and I’m trying to figure out what I was going to do in terms of specialty and what I would pursue career-wise, and I heard that report and I said, “I think I wanna do that. “I think I wanna focus on that because that’s “gonna have a big impact for the next several decades.” So, a lot of my work since then was focused on moving my career towards being able to build a sort of a super-specialty, ultra-specialized area of medical practice, focusing on using PCR for diagnostics.

– And was pathology the right specialty to choose to do that?

– It was. When I finished the program in ’88, if you knew the difference between CPR and PCR, you were like the Heisman Trophy winner for the year. So you’re recruited everywhere, right? So, I was able to strike a special deal with my department chairman at Yale in the Laboratory Medicine Pathology Program there to provide me with a lab and a technician while I was a resident.

– Wow.

– So, I was able to continue doing stuff and getting publications out while I was in my residency training there at Yale.

– [Interviewer] Wow, what a gunner.

– So, that was really cool. And I had planned on staying there at Yale, but then publications came out, got a science paper out of it, and that hit the news and then Mayo Clinic calls and says we want one of those CPR guys. And, you know, PCR guys. And we want a CPR laboratory, a PCR laboratory. And we wanna put a lot of resources into building one of the first, most advanced PCR laboratories in the world. So, it became an offer I couldn’t refuse.

– [Interviewer] Wow.

– And so, we thought about moving west, back to the West Coast. We didn’t quite make it there ’cause Rochester, Minnesota is not all the way out to the West Coast, but we ended up spending the next decade at the Rochester campus for the Mayo Clinic. And, back then, the technology was very crude by today’s standards, it was very much manual. You had to carry out the amplification and detection in separate steps, and the biggest problem with PCR was contamination. Because you’re taking a few copies, creating trillions of copies, and then you’re taking that tube with trillions of copies and transferring it to another chamber. In the process, amplicons fly, all these PCR fragments fly and they can contaminate the environment.

– They call them amplicons?

– They’re called amplicons.

– It sounds like some sort of Transformer, or Decepticon.

– [Dave] Ya, exactly.

– Amplicons, transform and rule.

– Bumblebee amplicon.

– Oh, well played.

– Yes, yes.

– Yeah, but, actually it was a huge problem technically. So, I spent the first three years at Mayo figuring out ways to avoid contamination problems and published a lot about how to do that. And, taught a lot of people who do PCR now how to avoid contamination in their laboratories. But, along the way, because of that publication record, I kinda became known as the King of Contamination, the guy who knew most about contamination. And as a result of that, I got a call in 1994 by Barry Scheck who is the criminal defense attorney, the forensic specialist for OJ Simpson.

– Okay, hold on, hold on. I just wanna make sure I confirm something here. Barry Scheck, who worked with Kardashian.

– [Dave] Right.

– So, by being here with you, we shook hands earlier.

– Yeah.

– I am one degree of separation from the Kardashians.

– Okay.

– I just wanna confirm that. So Barry Scheck calls you?

– [Dave] Yeah.

– [Interviewer] It’s like what, ’95?

– Out of the blue I get a page and I get a call transfer. I’m walking down the hall, pick up the phone off the hook in the hallway and it’s Barry Scheck. So that led to a series of communications about what contamination is, how it could affect forensic evaluation using PCR technologies, and, you know, whatever you think of the case, the bottom line was there were problems with the forensic evidence in that trial that were associated with contamination. And the good news is that the whole field of forensics has changed to allow for better control of contamination problems and really moved toward a much more rigorous, stringent process that allows reliability of results using PCR and forensic analysis.

– So those problems have largely been overcome or ameliorated and Johnny Cochran should’ve said, “If the amplicon fits, you must acquit!”

– [Dave]That’s right.

– That’s all I’m saying. That is, that’s amazing. So you’ve seen and you’ve participated in the growth and miniaturization and improvement in PCR over the years and it’s been your passion and your calling.

– Yup, exactly. So, over the years the technologies evolved to where it’s a lot less hands-on. It’s now self-contained, so contamination is not nearly the problem it used to be. It’s still a problem in some settings, but not nearly the problem that we dealt with early on. And, it’s made it possible to develop and to democratize that technology across a lot more places. But when I finished my tenure at Mayo, it was still something that was the domain of reference laboratories. And even now, a lot of molecular testing occurs only in reference laboratories, because of the special procedures and skill sets that are required. So, toward the end of my time at Mayo I was really feeling the need to scale, the need to go beyond, as much as I loved patient problem solving at Mayo, and I had a lot of the most interesting patients at Mayo that I was consulted on to provide molecular testing, I felt the need to scale. Scale or bail. It was like make this technology more accessible, more available and so there was, and we were just on the edge of being able to automate a lot of the procedures that went into the PCR process. So when I joined Cepheid in 2005, I saw this cartridge that looked like it would be able to automate a lot of the steps in PCR. And actually, here’s the cartridge here that we worked on, and essentially, this was taking my four-room PCR facility at the Mayo Clinic with a small army of technicians, and–

– [Interviewer] Ya, hold it up high so we can see it. There we go, yeah.

– There it is, yeah. And using the 11-chamber capability of this technology to be able to automate all the steps of sample extraction, purification, amplification, and detection in the automated process. And so, that made it possible to think about actually moving this technology out of the reference lab setting and making it much more widely available.

– So honestly, this is why I wanted you on the show because all the other stuff is very interesting, but it’s an archival sort of path to where we are now and with your work, working with Cepheid, you’ve miniaturized. Can you throw that cartridge my way? You’ve miniaturized what used to take a massive set of rooms and staff at Mayo into this and a machine–

– Yup.

– And, where this interested me is in the disruption of diagnostics and therapeutics across disease pathways.

– Right.

– So, we’re talking about infectious diseases that take, currently take too long to diagnose, too long to test for, need to go to specialized facilities, we can now do this quickly, cheaply, and accurately in a way that was unimaginable before. And that’s when I got more interested in this intersection of deep science and management of flu. It turns out it’s something you’re really crazy about.

– Yeah, absolutely. Flu testing has been a big challenge over the years because of the fact that a lot of the technologies in use a decade ago just weren’t as reliable as they needed to be. You could generally trust a positive result but you really couldn’t trust a negative result.

– So it was very specific but not sensitive?

– That’s right.

– Did I do that right?

– You did that absolutely right. So the positive predictive value is better than the negative predictive value of the test. So, we endeavored to change that with a flu cartridge that we developed a few years ago. And, we were very successful with that, but during the course of a few seasons we were seeing where some of the molecular tests that were developed were losing their ability to detect the strains that were occurring during the course of the season because of a mutation that happened in the target gene that was being amplified.

– So in other words, as we all know, many people know, the flu is constantly modulating, mutating, changing, and that was befuddling the test, the molecular level test.

– Yeah, even the molecular tests were getting befuddled.

– Looking at DNA, or RNA in this case.

– So, we didn’t wanna go back to the way things were with the antigen test so we ended up completely redesigning our flu cartridge to include not one genetic target, but three independent genetic targets that were highly complementary, that compensated if one of them lost, if one of them developed a mutation. So the other two would still function. And we also said we really need to prepare for the worst with this technology; we need to build in the ability to detect avian flu strains. If the worst happens–

– The so-called bird flu.

– A bird flu. If the bird flu, which is, what happened in 1918 was a highly reassembled, reassorted virus that included bird flu segments.

– How many people died? Something like 20 million?

– Estimated up to 100 million people died as a function of that. And probably a bigger impact than World War I in terms of overall worldwide mortality. But, it was a big, it would’ve been a huge problem for any flu test to be able to pick that infection up. And so, we built in an avian target, an avian preferential target in the assay as well. And the idea was to make it bulletproof, that it wouldn’t be subject to seasonal drift and antigenic variation, mutational variation, so you could rely on it year over year.

– And that drift and that antigenic variation is what makes flu so difficult to sort of become immune to or generate vaccinations for because it’s always changing and to target the antigen–

– Exactly.

– The targets are changing.

– [Dave] Yeah, exactly.

– Right. So testing is still a problem, so it’s also a problem for testing.

– It’s also a problem for testing.

– Why is flu so evil? What is it doing to us?

– It’s just the nature of an RNA virus. It mutates very quickly, it’s very adaptable, has a very plastic genome that accommodates a lot of changes over time, and it’s just part of its adaptability.

– I see.

– Across species, and within a species.

– Is it because error correction within RNA is less robust?

– It’s likely that there’s immune selective pressure happening in the population that’s infected, so you that get these immune escape variants that are mutational variants that are difficult to detect. The vaccines have been, are typically assembled based on what’s expected to happen in the upcoming 18 months. And usually they’re right, some times they’re not right in terms of the mix of strains in the vaccine. Overall, the vaccines have been highly effective. A recent paper in the New England Journal saying that actually influenza has a huge impact on cardiac morbidity and mortality because of the fact that it produces this highly inflammatory state and may actually affect the myocardium. You know, this is really important stuff.

– Let me put an emphasis on that. So, this data showing that people infected with flu are more likely to have heart attacks, more or less, to simplify it, because of the reasons that you said. This is yet another reason that flu can be very dangerous and why vaccination, getting vaccination right is important. So, sorry to interrupt.

– Yeah, that’s absolutely right. Vaccination is still our best strategy for preventing flu. Even if the vaccine’s not fully protective in blocking the infection completely, it still has an effect on reducing the severity of symptoms and that’s gonna have an effect on morbidity and mortality. So, but even if a case does come into the hospital that’s infected, it’s important to be able to identify the case quickly, to institute antiviral therapy if they’re gonna be admitted to the ICU to prevent complications downstream and try to block transmission within the hospital setting by getting ’em on antivirals quickly. And this is a very important strategy that fast testing enables to happen.

– Can I ask a question? So, in terms of predicting the composition of next year’s vaccine, would extensive molecular testing like what you guys do and offer, on a mass level, with data that fed back into CDC, would that help us design better vaccines?

– It could. I think the, one of the hard things to do is predict when the flu season actually starts.

– [Interviewer] Right.

– Right now samples get sent to state, state public health labs, local and state public health labs and then CDC. It’s about a two week delay in assembling all that data. Wouldn’t it be nice to be able to pull data directly off the instruments as they’re testing patients in real time, in emergency departments and hospitals and feed that into a Cloud-based system to actually look at the breakdown of results? Is it flu A, is it flu B? Is it respiratory syncytial virus? In real time. And, maybe even be able to look at the amount of virus present, season over season on average in the population. Would that be a predictor of the effectiveness of the vaccine for that given season? Would we be able to look at, season over season variation, in average viral load values to be able to predict severity of the flu season?

– See, this is fascinating because it’s a big data play at the small level, taking that data and feeding it in. Google’s tried it, used symptoms stuff to predict, but we could do it very accurately and precisely.

– Yeah. What Google Flu really needed was, was the goo. They needed someone to put the goo into Google Flu, which was the snot, the stuff that you test–

– The sample.

– The actual result for influenza. That would be a lot better at predicting the accuracy of predicting the severity of the flu season. So I think that’s where the technology needs to go. It’d be nice to know that hey, listen, we got flu cases coming up, I need to stock up on Tamiflu, and I need to order more flu tests and to know in advance before it actually hits the fan.

– Now you, before your work with Cepheid, you actually worked a little bit on vaccines in adjuvants and things like that.

– Yeah.

– Do you yourself get the flu shot? Are you a believer?

– I absolutely am, I get it every year. And, we depend as a population on something called herd immunity, to be able to get enough people vaccinated. Not everybody’s gonna get the vaccine but if you get enough people vaccinated, you can actually block the effectiveness of transmission of an epidemic because the infection will run into somebody who’s been vaccinated, it will be a dead-end there, and the kinetics of spread of the infection are affected by how many people are already immune. So it’s important to develop that herd immunity. That can happen through natural infection.

– [Interviewer] Right.

– But it can also happen through vaccination. And the combination of natural infection and vaccination to provide a boost to your already existing natural immunity is very important.

– Seems to me that your technology, this technology of rapid flu testing, molecular testing could actually start to analyze vaccine patterns of efficacy and lack of efficacy. So, you’ve got a vaccinated population. Some of them are infected, they end up get actual flu. You do the actual flu and you figure out exactly what it is. And maybe even viral, can you do flu viral load?

– Yes, that’s the idea. I don’t think a viral load value in an individual patient is that useful.

– Right.

– But I think if you take tens of thousands of patients and look at average values and you categorize ’em by age and vaccine status, gee, wouldn’t that be nice. If you saw that vaccinated people had lower viral loads on average, even if they got infected despite the vaccine, at lower viral loads than non-vaccinated, you might be able to say hey, that’s a good match for this year.

– Got it.

– If you see zero delta, that’s maybe a bad sign, maybe something new, maybe an avian flu strain is now appearing. So, if there’s no protective effect of the vaccine, would that be a way of monitoring the effectiveness of the vaccine, also predicting the severity of the flu season?

– And last thought relating to that, there are a group of vaccine folks and even people who believe in vaccines in general who don’t like the flu shot because they swear they get the flu shot and they get the flu a day after or a week after.

– Right.

– I imagine you could actually do the molecular test on them very quickly and say well, yeah actually, you did get the flu ’cause it was a day after and it takes two weeks for the antibodies from the flu shot.

– [Dave] Right, exactly.

– Or, no, what you have is not flu, what you have is something else. Adenovirus, rhinovirus.

– Yup.

– And so we could actually put some of this nonsense to rest with actual science.

– That’s right.

– So, this to me is very exciting. I’m also excited that you’re a fan of flu shot. Having worked on vaccines, having worked on science, you actually understand how the stuff works and also have the human element of like we’re trying to save lives here. This is a deadly disease in cases. And you mentioned natural immunity as potentially being a block in, a kind of a herd immunity in itself, so in other words naturally getting the disease. But in the case of say varicella, chickenpox, people wanna throw chickenpox parties. Guys, they don’t remember–

– Yeah.

– There was something like, I forget what it was, 10,000 admissions a year for chickenpox-related complications. Skin infections, sepsis, pneumonia.

– We don’t remember polio as a population. As a generation we don’t remember the impact of polio. We don’t remember the impact of measles. We’re now starting to see some of that in Europe where they’re seeing outbreaks of measles, because of loss of vaccine uptake. In places, ironically, in the Congo right now, in an Ebola-endemic area, in the context of dealing with Ebola they’re also dealing with polio-like viral infections, measles, monkeypox, and other infections for which there are no vaccines available in that population. And, those are confounders. Somebody gets a fever, is it Ebola? Maybe it’s measles. So, this needs to be sorted out but the bottom line is that if you actually see the impact of these infections and the significant morbidity and mortality they can produce, if we can go back and revisit history on polio and how many young people whose lives were destroyed as a function of polio in the 1920s, ’30s, and even ’40s. Look at the FDR story. Right? I mean this was a big deal and we’ve lost that generational memory of the impact of these huge problems and I think we need to understand that better and realize that in fact, there are a lot of benefits to doing what we’re doing with the current vaccine approaches and my former thesis divisor Don Ganem said, “You always have to ask yourself: “Is the juice worth the squeeze?” Is the juice worth the squeeze? And, I think in the case of many of the vaccines that are available now, the juice is definitely worth the squeeze.

– So, tell me what, what is this technology being used for now through your company that is gonna transform how we care for patients.

– Sure, I think, I’ve said we’ve gone from trick-or-treat to test and treat. Previously you had tests that would kind of trick people into thinking they were reliable, but usually they were more reliable for positive results than they were for negative results.

– [Interviewer] Yeah.

– Because they weren’t that sensitive. If they were positive, yes, they were probably flu or a group-based strep, or TB. But if they were negative, you really couldn’t trust that result. Now, the results are much more reliable. And the negative result, you actually can trust in these technologies. And so, what that has allowed for is a lot greater confidence and the speed to the diagnosis that allows you to make a real time decision about what to treat with, how to manage a patient. And that’s played out on a number of fronts worldwide with our technology.

– ‘Cause I can imagine, even just on the flu front, if you’re working in the emergency department, a negative test is incredibly important to be able to trust that result. If you don’t trust it, you start to hedge. Do I admit the patient? Do we observe? Do we bring them back first thing in the morning? And it becomes expensive. Inconvenient for the patient and potentially dangerous. So, I can think about things that you and I have talked about. For example, tuberculosis testing.

– [Dave] Right.

– How might, because right now it is an ordeal to test for TB.

– Right.

– How has this transformed that process, not just here but worldwide?

– It’s actually a great story. Actually goes back to the Mayo Clinic, so, in 1994 I had a post doc working on a test for tuberculosis that would go straight to sputum and amplify the drug-resistant genes out of the sputum and say that it was TB and also that it was drug-resistant. And when he wrote that paper up, he, in the discussion section he said, you know, some day this technology may actually make it out to where it really counts, which is in places where drug-resistant TB is more common. In Africa and other places. And, my comment back to him was, “That’s never gonna happen.”

– Wow.

– This technology is way too complicated, requires a four-room PCR facility and DNA sequencing. But I let him keep it in there, and I’m so glad I did because I was wrong.

– [Interviewer] Wow.

– I’m happy to be proven wrong that in fact, that approach finally did make it in to this format that allows us to directly detect TB and drug resistance directly from sputum in about an hour to an hour and a half.

– That’s ridiculous. So not only, okay, let me just understand this in my very, very, very sad hospitalist’s brain, in an hour based on a sputum sample, you can first of all diagnose TB as present, second of all whether it is drug resistant TB?

– [Dave] Yup.

– Using this process?

– Yup.

– I think you said it when you said in the US, that’s fantastic, around the world it’s life-saving, crucial, transformative.

– Absolutely.

– And so, are you deploying this? Or are you just squirreling it all behind a door somewhere?

– No, actually, it’s received endorsement by the WHO for implementation worldwide, recommended to be used in a variety of settings. It’s led to the installation of over 18,000 systems, about half of which are used for TB testing. It led to a special pricing agreement that allowed us to sell that cartridge at a low cost that was subsidized for a while until we had volume sufficient to keep it at that low price on its own. And that has led to worldwide uptake of that one test. So that one test has really allowed Cepheid to become a global company, more than any other technology.

– Let me focus on that statement for a second because this is what I’ve been talking about with our Z-Pak for a long time, which is, you can do well financially, you’ve become a global company, you’ve grown based on the science that you guys have developed. You can do well financially by doing good for human beings in the world, which you have done. And it’s that intersection that is what we call Health 3.0 and that’s why we’re really excited about this because, I mean, what part of the, this is just a nerdy question. What part of the resistance element of TB are you amplifying to test? Is it a plasmid? What’s carrying the resistance element in the DNA?

– Right, so it’s actually a part of the genome that it encodes a polymerase, an RNA polymerase that is the target of rifampicin. So, rifampicin is a surrogate marker for multidrug-resistant tuberculosis. If it’s rifampicin-resistant as a TB strain it’s much more likely to be resistant to other things as well.

– They kinda go hand-in-hand.

– Exactly. So, it’s a surrogate system for going down the pathway of using a very different treatment regimen for tuberculosis.

– Do you need a follow-up test? If your test is positive do you need to confirm with anything? Do you need further testing for drug sensitivities, et cetera?

– That’s being looked at right now and Cepheid is actually developing a cartridge for TB that looks for other drug-resistance markers. That’ll be available in 2020. It’s a follow on to that test to see which alternative treatment regimen is going to be most effective. So, but that’s the entry point right now. That’s the one that says it’s sensitive TB, you can use the usual regimen versus you need a second-line regimen that involves a lot more drugs and greater toxicities. We’re trying to get away from injectable regimens right now for drug-resistant TB. That’s in the works. But knowing more about the drug resistance that you’re dealing with is gonna be part of our future as well.

– So it seems to me that that would open the door for things like Ebola, HIV, HCV, other infectious agent testing.

– Absolutely. So, once you have the systems out there and those systems can be used to run a variety of tests, not just TB, it took a long time for us to convince the world that actually that box that you installed for TB testing can be used for HIV, chlamydia, gonorrhea, Ebola, other applications, and they can be run all at the same time if you need to. You can run them in a random access mode. And so what has essentially happened is we’ve now created a laboratory capacity to run a whole menu of tests. And in much of the TB-infected or endemic world, HIV is also very common. So treating patients and diagnosing patients who have HIV for the presence of tuberculosis is very challenging.

– So it’s almost a panel now. You can so okay, these things co-ride with each other often. Well that makes me think well, why are we, this can’t be limited obviously to the developing world, a panel of sexually transmitted infection testing. You know, we just did a show on expedited partner therapy and how we just assume they’re infected if the target case has chlamydia or gonorrhea, and treat them prophylactically, but if there’s a panel that you can just run, especially since the stigma’s so high for testing and that would make it as easy as possible. Do you have such a thing?

– We do. Actually, we have a chlamydia/gonorrhea test which is being wide adopted. One of the most impressive demonstrations of the power of a test and treat protocol is at a clinic in London called The Dean Street Clinic.

– [Interviewer] I’ve heard of this, yeah.

– Yeah, and they’re in the Theater District in Soho, not far from the Broad Street Pump. I don’t know if you learned about the Broad Street Pump–

– Yeah. That was the cholera epidemiology, yeah.

– Yeah, just walking distance to the Broad Street Pump. But this clinic is very active. They deal mostly with gay men and they do, they have a walk-in clinic where, it’s a very comfortable setting where patients fill out a history, self-collect specimens, and then they get the assay started on a big Infinity System sitting there in the clinic which they’re watching run while they, while they’re there. And they can either wait for the result or they can go back out in the street, have coffee, and they get a text saying hey, you need to come back or you’re good to go. And this means a lot to them.

– Wow.

– It alsois very important for interrupting the chain of transmission to get those results quickly and the patients treated quickly.

– So let me put a emphasis on that. You quickly, in this very convenient way, that I imagine actually has a high value, so it’s cost, convenience, quality, accuracy are all there, they get their results. So, instead of waiting and stressing out and inducing anxiety and continuing potentially to transmit if they’re infected, you block the chain of transmission early with quick, accurate diagnostics that are easy. See, this is how we oughta be doing things.

– I actually went in there as a patient.

– Oh yeah.

– And registered. It’s a free service.

– [Interviewer] And you were pan-positive across the board. Right?

– Well, so I went through the process, filled out the survey, got my Dean Street card for future entry so they have my information. Just plug it in and get tested immediately. But I got tested and about two hours later I’m sitting in a meeting with a bunch of my colleagues who do the same thing and I got the result back that I was negative.

– Awesome.

– Which, was not too surprising to my wife. But she was happy to see that–

– Could you imagine the other text? Please come back.

– Yeah, but it was funny ’cause we were sitting in the room with our colleagues and they’re getting texts around the same time and I’m looking at the facial expressions around the room as they’re getting these texts and, yeah. So.

– Yeah, I can imagine if it’s just That is transformative.

– Yeah.

– [Interviewer] That’s transformative.

– It is. And that model has gone viral, or chlamydial. You know, really to extend to other clinics in the UK where there are now some clinics in the US that are following that model, and we think it’s a critical need to be able to identify these infections quickly, especially now in the age of PrEP.

– The pre-exposure prophylaxis for HIV, yes.

– Yup, where they need to be tested frequently for both HIV and CTNG.

– [Interviewer] Chlamydia and gonorrhea, yeah.

– Yeah, chlamydia and gonorrhea. So, this is really important stuff because it’s critical in reducing transmission pressure within the population to avoid that window of uncertainty about not having your result where there could be transmission opportunities, closing the gap between getting the result and getting treated. And even in partner notifications, it makes sense to put testing in place there because not all the partners are gonna be positive and it would be nice to know–

– Before you treat.

– On the basis of a definitive result whether you need to treat or not.

– So it’s just much faster, it’s easier, there’s less stigma, there’s not, you know, it’s automated in a way that young people are actually used to getting a text instead of having to talk to somebody.

– [Dave] Exactly.

– And be a little uncomfortable and that kind of thing that the kids these days are just So, to me,well, okay here’s a crazy question. I see the need for this in another community that could desperately use it, for quick, accurate STI testing and that is the adult film community. Have you guys explored that as a potential?

– We have not but we’ve heard the same concern, that actually there would be value I would think in testing and treating quickly given the frequency of exposure of this crowd, that it would make sense to be able to try to block transmission in that setting as well.

– And all joking aside, this is a crowd that is not using condoms and safe sex, and so, as a result they are actually at higher, and there’s been some events where people have been infected. This again, I think this, to see, did you ever think it would get to this stage?

– You know, we only hoped a few years ago that it would get to this point of being able to really drive actionable results that could lead to decisions that are specific for the condition that is found at the point of care, and this is becoming reality. So.

– You know, what you guys have done with flu is really interesting. We did that video about it and I learned a lot from that, because I used to rely on those swab antigen tests and to see that there’s a better test that’s more accurate, that’ll help me make clinical decisions. A lot of times I do it clinically, this person definitely has flu and we’re not given everybody Tamiflu anyways, but for those that are at risk that we do, it’s a really transformative technology. Do you see it continuing to improve to the extent that it gets faster, cheaper, more, it’s already highly accurate, but more available? Because I think one of the big concerns a lot of people have, if you’re working in a federally qualified healthcare facility or with lower income people is can we afford this and is the cost benefit worth it.

– Yeah. I think there’s, it’s always getting faster and less expensive; that’s the trajectory of technology in general, and Cepheid is no exception. There’s also recognition that in many parts of the world that central lab testing is actually more expensive than doing it on a decentralized basis. So, for instance, in Africa, if you’re trying to diagnose HIV, get an HIV viral load in a setting that’s not near a central lab, often the venipuncture sample gets drawn, it gets sent to the central lab, and then the results come back weeks later and the patient’s nowhere to be found. And then they have to redraw and retest because there’s a time gap between the first and second sample, so you don’t know what the real viral load is at the time of testing. And so you’re looking at doing multiple tests to get one that actually can be actionable. And so having this technology, which is more expensive than a single central lab test but less expensive than multiple central labs tests, and actionable the vast majority of the time because the patient is still there when the result is delivered, that is a huge cost saving.

– So get it right the first time, right there at the point of care where you can actually make the decision, the patient’s still there.

– Yup.

– Yeah, see that to me is the compelling, the most compelling case for that. One thing pre-exposure prophylaxis for HIV, PrEP, I had my brother-in-law on the show, he’s an ID doc in Michigan, it’s one of his passions. What’s your thinking on this, the new drugs coming out and how does it relate to the testing that you’re doing?

– Right. So, clearly there’s a need for frequent testing for chlamydia and gonorrhea because of exposure that happens in patients who are on pre-exposure prophylaxis. There’s also a need for hepatitis C testing ’cause that’s one of the infections that’s on the rise.

– So, in other words, people who are on the PrEP regimen thinking okay, maybe I’m okay about HIV, a little bit more protected, they can still get gonorrhea, chlamydia, HCV.

– Yup, exactly.

– And we need to test, yeah.

– So, monitoring for increased risk for those infections needs to happen. In addition, there’s a compelling need for better, faster HIV diagnostics; number one, to qualify a patient for PrEP, they can’t be infected when they start PrEP. So you have to declare them negative, clearly negative with a sensitive test before they start PrEP. And, you don’t wanna wait for that result because when you decide to put them on PrEP based on a negative result, it may be 10 days out, they could’ve gotten HIV in the meantime. And I’ve heard actual stories about patients who become positive in between the first blood draw for HIV diagnosis and then getting the first administration of PrEP. And that’s not a good thing because the virus becomes resistant in that context.

– Time is virus, in this case.

– Yeah. So having the capability of doing a same-day test and treat protocol for HIV, for PrEP qualification would be a game changer. And likewise, monitoring them frequently for infection once PrEP is initiated ’cause you can still get breakthrough events that happen because of non-compliance or other reasons, and they need to be monitored for HIV infection alongside chlamydia, gonorrhea, and other things. And that’s, getting those results back quickly even before there’s evidence of antibody or antigen proteins for HIV expressed, we give an early opportunity to detect infections before they become fully transmissible.

– So, it sounds like, and here’s a question that my audience is gonna wonder: How do we start to access some of this testing? Because maybe they’re working in a small clinic, maybe they’re working in a hospital, maybe there lab there, a lot of lab people that follow the show–

– Right.

– ‘Cause we did this one rap called In Da Lab and they were like someone made us a rap, that’s a strange thing and wonderful, because we deeply appreciate our lab. How can they start to learn more and get more advocacy going for this sort of testing?

– I think it is really, it’s already a movement that’s underway to provide rapid, actionable results on systems like ours, not just Cepheid but other systems, that can provide information that leads to treatment decisions in real time. You know, flu RSV testing was never something that was very popular in the reference lab because it just took too long, even if it takes a day or two to get results back, that’s too late. So, labs realize that to be able to provide the best information for their clinicians, they need to provide rapid turn around testing for that application. But I think increasingly they’re getting aware of the fact that there’s, this applies to many things across the board, outside of flu. For STI testing, chlamydia, gonorrhea, trichomonas, as well as other viral infections need to be detected more early.

– You know, one thought, I don’t know if you guys are doing this, but think about Ebola, a lot of the time you are quarantining people who have fever and signs of it with other Ebola patients. So if they went into quarantine without Ebola and now they have Ebola, do you guys have a technique to maybe test Ebola in advance?

– Yeah, we do. In fact, that cartridge that was designed for Ebola detection is now being used on a widespread basis in the recent outbreak in the Congo.

– Really?

– Yes.

– So you guys are using this there?

– Yes, it is. It’s being widely used. And it’s considered to be one of the major tools for identifying patients quickly. In the last outbreak that started in 2014, one of the biggest challenges with Ebola was that if you had a fever and you’re in an Ebola-endemic area and you looked like you might be an Ebola patient, you were quarantined with patients who did have Ebola and there was transmission, in the quarantine setting. So really not knowing for sure whether a patient was Ebola positive led to a lot of uncertainty, led to delays in case management and care, and it also led to more transmission. So this technology is now being used on the spot in a lot of places where the outbreak is happening right now. And it’s having a big impact on how they manage the emerging epidemic of Ebola and that is a very important piece of information for them that’s actionable, there are new treatments that are in clinical trials, there are therapeutic antibodies that have been developed, there’s an Ebola vaccine. If they find an Ebola case quickly, they can begin ring vaccination efforts to try to prevent more cases from happening around that case. They can trace exposures for family members that may have had contact with an Ebola patient to know who’s gonna be their next case of Ebola because of that exposure. And all this can happen within a few hours versus days or weeks in the previous outbreak.

– So this is science in action helping humans in need, that’s what we wanna see in this world, that’s why we’re so tireless in advocating for scientists like yourself and organizations that are working on this and why we will never stop fighting people who deny the science. We will be mean to them because we like to, and also we will listen and we will educate and we will move hearts and minds. Dr. Dave Persing, it has been such a pleasure having you on the show. It’s an honor to be with someone who took medicine, science, and passion for humans and combined it and actually made a difference in the world. Thank you so much for being with us.

– Thank you, it’s my pleasure.

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