Understanding the Point of Care Revolution

Chris:
Welcome to Clinical Lab Chat, part of the MEDQOR Podcast Network. I’m Chris Wolski, director of business intelligence for CLP. And today I’ll be speaking with Hamid Erfanain about the point-of-care revolution. Hamid is currently the CEO of Enzo Biochem, a molecular diagnostics company that provides a wide array of diagnostic products, including for point-of-care testing. So perfect guest for us today. He has over 28 years of experience as a seasoned healthcare executive specializing in the diagnostic medical devices and life sciences industry. And prior to his tenure at Enzo, Hamid was chief commercial officer of EUROIMMUN, a PerkinElmer company. And so welcome Hamid.

Hamid:
Good morning.

Chris:
Of all the changes we’ve seen to society due to the COVID-19 pandemic, for me, perhaps the biggest is how ubiquitous point-of-care testing has become. And we see that everywhere not just for SARS-CoV-2, but for other diseases, including unfortunately, or fortunately I guess, our newest health emergency, monkeypox.

Chris:
Now Hamid, I hope we can drill down a bit today and talk about why point-of-care testing has taken off and what it means for labs and society as a whole. So let’s start at the beginning, why has point-of-care testing really taken hold? I mean, was it on the verge of already of a tipping point before COVID, or did COVID just create the right environment for it to become ubiquitous?

Hamid:
So good morning, Chris. Thank you for having me on board.

Chris:
Oh, certainly.

Hamid:
And at the end of the day, when we start talking about point-of-care testing, this is not something that, again, came about around pandemic. We all remember back in, maybe some of you don’t remember, but I certainly do, back in 1977 when pregnancy tests became available at direct-to-consumer testing. And again, this topic of point-of-care testing was growing pre pandemic.

Hamid:
Now, when COVID came all about and as it became a pandemic, the need for quicker turnaround time and the demand for testing at home, maybe at point-of-care, became a desire. And folks started to respond to that, including Enzo Clinical Laboratories where we launched a GoTestMeNow™ solution. But ultimately, when you look at it, these became somewhat subject to accuracy of collection, ensuring that at the end of the day you are providing a result that a physician can do something about. So to that end, there was a level of comfort that you gain by doing point-of-care testing with COVID, but at the end of the day, the value of the lab continued to remain because physicians relied on this laboratory results and PCR testing.

Chris:
Right.

Hamid:
Now, again, to answer your question in nutshell, I think the demand is going to continue to grow, but accuracy, sensitivity and reliance on it is going to be much more important as we continue to move forward.

Chris:
Right. And so Enzo was and is a provider point-of-care. You kind of touched on that a little bit when we were just talking about your last answer, and you do a lot of other diagnostics. Was it necessary to pivot a little bit to meet the needs of COVID point-of-care testing and now other demands for point-of-care testing? Has there been a pivot with Enzo, or was this just kind of more of a you ramped up as a business-as-usual sort of response to COVID, and I guess now monkeypox, and some of the other diseases that we have floating around?

Hamid:
So Enzo Clinical Lab, we do obviously do team testing, folks go to patient draw station, collect their blood, send it to our laboratory testing, and this has been a traditional testing methodology for us for years. So we depend on our proprietary product GENFLEX® molecular testing that we do PCR testing.

Hamid:
During the pandemic what we saw was a search in demand in which it was hard for folks to get to potentially blood draw station or places where… They needed to go to a physician, they needed to go to school. Those were mandatory. To go into a blood draw station would require additional step in their journey to ensure that their samples are being collected and they’re sending it to the laboratory for testing or having the ability to get accurate results immediately.

Hamid:
So what we did, we started this platform called GoTestMeNow™, which gave us the ability to, again, bring that testing, bringing that sample collection, closer to the patient. And this is a venue in which was, it became very much, it talks to the excellence and the ability and the capability of our laboratory to be able to be responsive to that. And it continues to evolve for us. We provided COVID testing in this manner, now we started providing STI, sexually transmitted infection testing that way, and we continue to augment that menu for the ease of access and accuracy, the result that we put in the hands of the patient. So I see this continuing to evolve for our laboratory, and overall, for the society as testing gets closer to the patient.

Chris:
Right, right. And certainly, and this is something you and I have talked about previously, access is a big part of this, and you kind of touched on this, that testing isn’t just about getting the answers, but being able to get people in to get tested. So having that access to a testing site or the test itself.

Hamid:
Yep. Yep. Absolutely.

Chris:
All right. Okay, you alluded to this a couple minutes ago, but where does point-of-care testing, particularly rapid point-of-care home testing, which we’ll talk a little bit more about in a minute, where does that leave labs? I mean, how do they need to look at this change? Is it a scary revolution? Is it a natural evolution? What should lab directors, a lot of our listeners or lab directors, what should they be thinking about this as this ubiquity continues for many, many tests?

Hamid:
So as far as I’m concerned, this is an excellent time for laboratories, because if pre pandemic we would both walk down to the nearby grocer and we would ask them, “Can you tell me a little bit about PCR testing? Can you tell me a little about rapid testing?” This knowledge was somewhat, again, wasn’t as readily, as easily available, and it wasn’t on the forefront of folks’ mind. We all saw during pandemic diagnostics was a critical, critical part of, again, responding to COVID, and responding on the way that we work as a society. So we know that 80% of all physicians’ decision really relies on laboratory testing.

Hamid:
So this idea of, again, rapid results is I don’t see it going away. We all saw it, again, alluded to this earlier on, first pregnancy test over the counter became available in 1977 and it continued to evolve. However, there are evolution, there’s going to be, in my opinion, evolution of point-of-care testing, which is all about sample collection, accuracy of ensuring that, again, that what you are putting in the device or the point-of-care or rapid kit that you obtain is accurately collected. Then the next thing is we want to remove any environmental subjectivity that comes around with it.

Hamid:
And ultimately, I see this as a positive message for laboratories and central laboratories because awareness of diagnostics is at all-time high. And ultimately, there is a need for testing within the laboratory because we are not looking for results of positive negative. You’re looking for quantitation of results. You want to make sure you’re monitoring the results. Again, we see this evolution around ensuring that you have immediate gratification, but ultimately, central laboratory, because of the training, again, it takes a number of years for folks to be able to train and become efficient, and doing those testing, interpreting the results, ensuring that even that the upfront collection is done accurately.

Hamid:
This getting testing closer to patient, maybe at the physician lab offices or at physician offices, is going to be a natural progression of testing. But ultimately, if you ask me what would it look like 10 years down the road, The role of central laboratory is going to continue to stay intact. It’s just access to those results in the hands of the patients is going to be extremely important.

Hamid:
During pandemic, we all saw who didn’t get their brain picked during pandemic. We all saw subjectivity of ensuring that, again, the sample collection is accurate. So this becomes a critical juncture for us as we continue to move forward ensuring those tests give that type of accuracy with, again, ease of collection, accuracy or efficiency of collection.

Chris:
Right. It’s interesting because I’ve talked with some public health, people who’ve been doing some public health testing as well, and there’s a really interesting tension between a regular person like myself who’s just… I write about medicine, I’m not a medical person, and who just wants to know am I sick? As opposed to someone, as you’re talking about the central lab or physician, who needs to know exactly how sick, what the person’s sick with, et cetera. It’s not so much… It really isn’t important to me which strain of COVID I necessarily would have, but that do I have it or not? Whereas it would be really important for your physician and also public health officials to know what strains there are in order to have the proper individual healthcare program, and also be able to see if there’s a new strain, or if a particular strain is becoming widespread throughout the population.

Chris:
So I think it’s a really interesting point you make there. So that takes us on to home testing, which is something I’ve done recently. I recently did some traveling, and I had to do a home COVID test. And thankfully I was negative. But I have to say it was super easy. It was fast. It gave me some real peace of mind. It kind of ticked all the boxes that you were just talking about, Hamid. So what does the future of home testing look like from your perspective? You kind went back in time, and I like that connection to the home pregnancy tests, that kind of sets the stage for many of the home tests we have now. And we’re all, probably most of us have done the home genetic tests and things of that sort for our ancestry tests. So what does home testing look like in the future from your perspective?

Hamid:
I do see the market for home testing growing. At the end of the day for example, we saw, as you alluded to it yourself, you did potentially some COVID testing. And it’s easy, it is quick, it gives you immediate gratification. And at Enzo Biochem we are starting, we are continuing to explore ideas around point-of-care. We are already got the GoTestMe platform that we’ve launched. We are going down, again, a potential of having a molecular point-of-care testing that we could be putting in urgent cares and closer to the patient testing.

Hamid:
However, I do worry about, as we get closer to the patient and we put this rapid testing in the hands of patients, a potential of user error. We are talking about, again, let’s look at, for example monkeypox. Monkeypox testing as news of it continues to evolve, ultimately, the accuracy in which you are providing results at a rapid pace currently is not available. We are all dependent on central laboratory.

Hamid:
However, again, the collection methodology where on the, again, lesions you’re collecting the samples. Is it already on the healing? And are you collecting it appropriately? These are, again, as we see, as we are learning more about monkeypox and it’s starting to evolve, we start to see that, again, COVID testing maybe lend itself to getting immediate gratification, getting the result, but again, is monkeypox appropriate type of testing to be done rapidly at home? Is it the collection methodology? Is it error prone? Are you collecting it from appropriate lesion? Is it on the heel?

Hamid:
So at the end of the day, when I say that the demand for rapid testing is going to increase, I absolutely believe in that because as millennials continue to retire, as baby boomers continue to retire, they’re all used to looking at immediate gratification by having our mobile phones in our hand, and just seeing a result right there, and it’s convenient. You don’t have to go see a physician. You could just make a determination immediately. Move forward. But ultimately, what it comes down to is treatment, it ultimately comes down to physician intervention, and reliance on ensuring that as you are healing, as you are continuing to overcome a disease that you have, you are under proper care. And for that, you do require the central laboratory testing.

Chris:
Right.

Hamid:
So this evolution of moving to rapid testing is going to continue because this is the generation, this is the time that we live in. We want immediate gratification. But ultimately, the dependence on ensuring that you are continuing to monitor the progress of the disease, or there are certain disease states that don’t lend themselves to rapid testing, is going to bring awareness for the lab. So I am really excited to be sitting at a helm of a company that provides these type of solutions to patients, and it’s a good time for laboratory.

Chris:
Yeah. But I think one of the things I’ve, just as opposed to the gratification part of it, now one thing, and we talked about it again, I want to go back to this briefly, the access part of it. I think that’s another part of it. I think it’s also, let’s go back to the home pregnancy test, there’s certain situations where it’s a very sensitive type of testing. It’s very personal. You don’t necessarily want to be calling up your doctor and say, “Hey, I need to come in for a pregnancy test,” just because you think that you may be pregnant. Certainly you should follow up if there is a positive as you were kind of indicating. But I was thinking also with just, I know there’s a number of STI home tests that are out there. I’ve thought quite a bit about that.

Chris:
There’s a lot of stigma certainly with that sort of testing, and that it’s not just the accessibility and the immediate gratification, but it’s also people having the ability to do this in the privacy of their own home. And then hopefully, take the appropriate steps after the fact if they do come up with a positive test. I mean, take your point. You’re talking about particularly monkeypox, et cetera, but I’m also thinking in terms of not just the accessibility, but also there’s stigma with some of these kinds of tests or they’re a very personal sort of thing. There’s a lot of emotion involved. There was no emotion when I was taking COVID tests, but there could be some emotion for some other types of appropriate home testing. I mean, do you think that’s also one of the things that’s also certainly one the benefits of having more home tests that are appropriate and can be adequately used by a regular person like myself?

Hamid:
So I think you hit the nail right on the head, Chris. So there are certain set of tests that absolutely lend themselves for going to point-of-care testing. So STI happens to be one of them. Another area that you could also look at is drug testing.

Chris:
Right.

Hamid:
So there is a level of emotional connection and level of discreetness that comes along with it that could lend itself to testing. And hence, we did see that potentially with, again, genetic testing for folks to find out where their ancestry is from. So there’s all levels of providing testing that at the end of the day, there’s a level of emotion involved, there’s a level of curiosity that’s involved. However, ultimately, what we got to look at is the role of diagnostics, the role of laboratories. What we do is we provide, A, to the physician, not just satisfy curiosity. There’s a level of curiosity. There’s a level of emotional issues involved.

Hamid:
Let’s take, for example, STI testing, ultimately, if you happen to be positive, if the testing that’s rapidly available at your fingertip is positive, there has to be a level of public awareness. That’s where public health labs come in. There’s a level of physician intervention that requires you go to a laboratory, central laboratory ultimately to get that result done, provided in the hands of the patient, and then the physician continues to monitor this as you continue to go through the process. So absolutely agree with you. This is a new time where we can take control of ensuring that there’s a level of discreetness that comes along with it. However, there is going to be interventional issues that would require central laboratory testing.

Hamid:
Let’s also, I want to take a minute and talk about some of the rapid COVID tests that became available. When you look at, again, some of the tests that was rapidly available in the market, again, all of us lived from looking at it from a laboratory perspective and diagnostics perspective, all the way to where we are at today. Initially some of those tests had a very good positive indicator that you knew if it was positive, you feel comfortable that your results were positive.

Hamid:
However, just because you obtain a negative result, still there wasn’t a level of comfort around ensuring that it’s negative because there is subjectivity around collection, there’s subjectivity around environmental factor, and there’s subjectivity around the test. So it’s important that those rapid tests are accompanied with care collection instructions, got to be appropriate. And finally, when it comes to intervention, you need your physician and the laboratory to get those results done.

Chris:
Right, right. So just to wrap up our discussion of home testing, do you think that home testing is to a certain extent, do you think that’s the real legacy of COVID? That everybody knows what a PCR test, everybody knows what a rapid antigen test is now. Do you think that’s the real legacy of COVID?

Hamid:
In my opinion, in my humble opinion, the real legacy of COVID is putting a lens on diagnostics. Having 28 years, almost 29, 30 years of my career in diagnostics, it was again, good news, bad news, we were going through a pandemic, we were sitting at home. But the good news for folks that worked in the laboratory field was really look at what we do, look at… Again, previously, got your blood drawn, sample collected, sent to… You didn’t know where it went. You didn’t know how it came out. Now, majority of the folks know that, again, diagnostics is pivotal in our life in a way that, again, healthcare is conducted. And again, we saw CDC step up and really guide folks through this process. But ultimately, we all relied on laboratories to ensure that we’re getting rapid, accurate results out.

Hamid:
And again, I want to just give one moment of calling and recognizing our employees that they worked 24/7. When folks couldn’t come to work and folks didn’t have the ability to come to work, our employees showed up, they did the testing every day, and provided accurate results for the patients. And again, that should be recognized. We were able to get a COVID Hero Award from Long Island Association because of some of that activity.

Hamid:
But overall, I think the legacy of COVID is, and the way that I see it, yes, we do need tests, yes, we do need rapid tests and quick results, but ultimately, it’s shined a light on the diagnostics industry and what we do day in and day out at the laboratory to ensure that folks, physicians receive accurate results to intervene and take care of patients. So I think ultimately, to me, that’s been the message that at least I collected maybe somewhat selfishly on behalf of our company Enzo Biochem for during this pandemic. I know if you feel the same, Chris.

Chris:
Yeah, I do. And I think it’s well said. I’ve written about this that I was one of those patients. I actually grew up in a medical household, but I was still one of those patients. They took my blood, and it went off to this magical place called the lab. And now I know a lot more about it, thankfully, because I do lead the CLP brand for MEDQOR. But also because I’ve talked with people like you and went through COVID like everybody else. And as you said, it really shined a light on the whole industry.

Chris:
So unfortunately though, we’ve reached the end of our time today. So Hamid, thanks so much for taking your time speaking with me today, and your take on this fascinating and important topic and really putting the right perspective on how important diagnostic labs are for all of us to stay healthy and happy. And that’s one of the things I do love about leading the CLP brand, as I mentioned, is that having that front seat during such a dynamic and exciting time for the laboratory industry, which I think as you rightly said, Hamid, I think is going to just continue on. I think we’re at the beginning of something, a really interesting time I think for the diagnostic laboratory industry.

Chris:
I also want to thank you the laboratory audience for listening and listening to our previous shows as well. Look for more episodes of Clinical Lab Chat in the future and visit us online at clpmag.com and on all of the major social media platforms. So until next time.

Hamid:
Thank you, Chris.