Interview with Steven Chang PhD.
Can you tell us about your current work?
I’m currently involved in a company called Mirimus which has the saliva direct test, that’s licensed from Yale University. We do pool testing on virus on saliva samples for COVID. In people, children, especially because they’re just requires the ability to spit into a container.
What is your background in the field of infectious disease?
The pandemic that I’m most familiar with is the HIV. And testing was really, really critical, knowing who had the disease, who, how you could diagnose it. And so it became pretty clear to me that testing a variety of types of testing needed to be done and available. And so many of us were looking around for things like a rapid antibody type tests of some sort, some to way to detect the virus and because we all recognize that the technology of PCR, which is quite revolutionary, itself, it was not necessarily easy to scale.
And can you tell us about sort of where the Mirimus test fits into the broader spectrum of tests that are being developed?
But the major issue is the invasiveness of doing a nasal swab. And it’s fairly invasive, and doing schoolchildren, is going to be more difficult. So when the saliva tests became readily, at least technically feasible, I thought that this could be a good solutions. The saliva test at this point seems to be really, really concordant with patients that actually have COVID or have the early signs of COVID.
Do you have a sense about how early the test like the saliva test, or even the PCR test can pick up an asymptomatic patient?
Very high. Because you’re detecting the presence of the virus in the viral RNA, because the saliva test actually is just a, a modified PCR test. It’s done in this case, in pools, on the pools can be anything greater than two. And you are then able to look at groups of individuals without violating some of the HIPAA rules and testing rules that state various states have.
How does your test work? [mepr-show rules=”18702″ unauth=”message”]
So it offers an opportunity to screen people, and basically telling this group of individuals a small pool of individuals that somebody in group is infected. And then you can either break it down further, each one of you should go in for a PCR test prescribed by a physician, because many of these diagnostic coded tests, at least in the state of New York, require a physician’s order.
So it’s not really home brew or things like that, you can’t you can’t just go in and do it yourself, and get this thing done. But what it does represents a way you can do these very quickly overnight you can clear a whole group.
And I think that is some of the studies been done, show that it certainly picks up a set of asymptomatic individuals, and certainly those are already showing symptoms.
So in general, though, as you as you just look broadly at the issue of picking up a symptomatic, assuming the PCR can always be better than the other tests the antigen test. what is the maximum time of exposure that if tested, let’s say every day that someone who is asymptomatic could be a spreader?
I don’t think we know yet. You know, it’s really difficult to do these experiments. Difficult to do a study. We can’t knowingly infect other human beings and do a controlled experiment. Though, you know, viruses have been done that way. Many, many of the courses of pathogenesis of viruses are done human actual, actual human experimentation.
And so we don’t know this, this you know, we’re relying on when we think a person got exposed. And then looking at that will require a very large body of data. That to actually amalgamate how early you can detect, what we feel comfortable is that it will detect somebody who is known to be probably in their infectious, highly infectious state spreading it coughing and things like that.
The interesting about the antibody tests, and that concerned many of us early on, were that there were people who were actual COVID patients but in some cases the antibody couldn’t be detected in them.
And so that was a mystery to many people. And so it was combination probably of the sensitivity of the assay, as well as the actual way to capture that.
So there were many instances of just false negatives, as well. So the rapid test at this point is not very good. Sensitivity seems to be an issue. It could because many of these use econometric methods, they’re looking at basically
if you’re familiar with the pregnancy tests, you see, in the case of pregnancy test to where you’re testing urine, you see the appearance of a band or your two bands, or whatever.
However, the assay is set up to the assay set up to see the appearance of something. And in many cases, those rapid tests for COVID. The they were weak. So people had a tough time interpreting that.
And I know that now, people are working on very, very ultra-sensitive detectors, fluorescence, which requires more of a specialized reader.
The specialized reader in the back which can move it to a cell phone to cell phones have the cameras and certain cell phones are very, very sensitive. So there are people are doing that. (see our story on luminostics).
But as of right now, still the most reliable test is a PCR test. And at Mirimus we’ve taken the saliva test version of PCR tests into what I call large scale testing, you know, thousands of patients per day,
What is the origins of this test?
It started off for schools, the founder and CEO of Mirimus is Prem Premsrirut who is both a scientist and MD PhD, who runs a biotech company service company. And she saw a need for it because she said many of her friends who are parents of small children, as well as herself, (and she has two small children), that there was this inability to go back to school. And she kept looking around like many of us to see if there was an antigen test is there. When it became clear, that nobody was coming up with anything, she took it upon herself.
Being an MD PhD needs that she’s pretty darn smart. And she developed the whole system. And so Mirimus now has testing services for schools and groups are interested. And they also have a foundation called the Mobilizing Foundation, https://mobilizing.org/ which is meant to underwrite the cost of testing for those who can’t afford it. The mission is to foster collaboration to develop effective testing.
The test is a licensed from Yale, and it’s called Saliva Direct. Yale developed this in conjunction with the NBA. We are one of the first three licensees. (the other two being_____ ) And it turned out, we were already operational, because we had figured out how to do a lot of testing very early in the game. And when the Yale system was just _____ basically revalidated our own system which pretty much match the Yale technology.
And so we’re moving forward and taking out as many individuals as we can groups to test. But recently we have not really needing to go out look for people are calling her based on word of mouth.
Who are your current customers?
Currently, we’re testing a lot of private schools in the New York area, and we hope that we can help the city of New York because since Mirimus is a New York company, called based in Brooklyn. It was conceived of in New York State, its technology came out originally out of Cold Spring Harbor, it’s financed through a venture capital firm that is based in New York, Long Island Topspin partners. So we’re all about New York, and the fact that we are, we feel that we can help the city and businesses in the New York area open up with the aggressive testing.
So and it’s done in a non-invasive way. So you know, everybody knows how to spit. This is especially useful in the case of children. Putting a nasal swab up into the nose of a four year old pre K or a kindergartener is you know, it represents a challenge to the nurse.
And it has to be done by a certified nurse, because the you know, the it is invasive. And it’s a technique and I had like I had done to myself, and I have to say it’s not painful, but it’s certainly not comfortable. And it’s certainly something I would not, not like to subject myself to every few days, unless I really had to. And so I think the saliva test represents a much better alternative.
So just in terms of the logistics of how it works, do you does your team then go to the schools?
So at each site there are people who we have trained that collect samples, and everything’s bar coded. And so we know that who gets what individual matches that barcode. And then then all the materials are sent through a courier who drops it off with us.
And then we do pool testing with each. And then from there, we amplify, and detect, and we usually get the results that evening. If we get a positive, then we have the ability to convolute that what to call pool into minimum groups of two, and then we can tell which group of two is potentially positive.
And, you know, it just works really well, because the vast majority of New Yorkers be given our percentage is still very low. So we were able to process lots of lots of samples. (why would this make a difference?)
What scale? Are you running at now on a bigger scale, could you accommodate?
At the moment maybe 5000 to 8000 samples, per day. We believe we can get to 50,000 samples a day.
It’s a matter of space, we’re, we run out of room at the downstate (Brooklyn) facility, we’ve doubled our staff in about three months. And so, and we anticipate doubling the staff in the next three months. (from 15 to over 30). And we believe that in the next couple of months may double again. So actually we are hiring people. And bringing in great people is an issue, always. And like all small companies grow we will have growth pains.
Prem is working 24 7, she is always on call. She says it reminds of being a physician, as she says. And so she’s always there making overseeing the activities of the lab in some of the many of the administrative issues.
How was this project funded?
We did it on a shoestring and through the generosity of some private donors, and a venture capital company, Topspin partners. The money was used to buy automated equipment, etc, and money was put in a couple million dollars of equipment that’s automated the processes.
So our footprint was not large. We didn’t really have to grow and have lots of people, we actually had equipment that has automated many of the steps that are challenging. And so the model is that with automated audit equipment much of the process can be automated and put into laboratory information management system.
So we actually have a whole system to make testing very, very affordable, and portable to the sense that this this group of technologies is assembled together, can be shipped off to other groups.
Do you have other places you hope to see this in motion?
Yes. So where we’re going to announce a collaboration with the Wynn hotel to set up their testing services. And we anticipate doing that for other large organizations around the United States.
Now that would that be a scenario where you would envision that guests at the Wynn hotel would provide a sample every evening and get results the next day?
I certainly could see hotel saying, hey, you can you can check into the hotel her providing you provide us, you know, a quick, rapid, you know, PCR test.
And I imagine there’s going to be a rapid type of test, not necessarily a PCR test, there’ll be available that within 30 minutes to know if your COVID positive, if not, I think that will be the ultimate goal of the field and certainly near term.
So that fascinating story. What are the economics of the test
Are you know, they’re under $20 for, you know for a group of tests. (is this $20 per person, or $20 per batch?) And so it’s actually very, very reasonable. And it’s affordable for first things with scale that like all things, you know, things right now will go down in price.
And so we’ve been working on the whole supply chain and logistics of who’s going to pick it up, who’s going to deliver back results as much as electronically as we can. And with all within the limits of privacy and things like that. So it represents a clearly an opportunity to streamline the all the operations, which will reduce costs. So, in terms of your outlook on just the general test therapy, vaccines and other
Do you have any sort of broad brush reviews, based on your experience as to what’s down what the future holds for us regarding COVID?
Yeah, I have great hopes. When I went into the HIV epidemic, as a researcher, and then actually working in companies, our greatest desire was to develop a way to prevent people from dying, and that pandemic that we had back in the 80s 90s, and that the fact drugs became available, and then a cocktail of drugs became available. And today, HIV is a degenerative chronic disease that can be managed. And 40 years ago, we thought we had to have a vaccine. and we still don’t have a vaccine.
What is your outlook on the arrival of a vaccine?
Vaccines are hard. It’s hard to make a vaccine. It’s not trivial a variety COVID as a variety of them. Some of them using technology never used before, and that scene development. And so we don’t know how well they’re going to work. We know that they’re currently safe. That people, at least in the first phase one and phase two, were able to tolerate the vaccines, we then have to now ask and I will assume that they’re safe. We now have to ask how efficacious they’ll be, and how long that efficacy is.
Some of the vaccines will be challenged, in the sense of challenging because they’re many of them are single dose vaccines, where they dose with, in this case, a viral vector, that person who
That most likely can’t be rebuilt very easily with the same vaccine again, say a year later. So it will be challenging to figure out how the logistics of that is.
As you may know, the flu vaccine is only good based on the different flu strains once a year, pretty much. So be interesting to see how well the COVID type vaccines work.
What is the outlook for Vaccines?
I have talked to many of them and the real best vaccines we have available to mankind are live attenuated virus vaccines, you know, polio, and things like that. And they themselves are and perhaps a live attenuated Coronavirus will be you know, somebody will be working on that.
In layman’s term what is a live attenuated virus?
Yeah, so it’s a virus that is it’s just like the virus that infects you. Except that it’s been crippled. And it replicates very, very poorly, but it’s enough to generate a lot. What it does is it replicates in, in cells inside of you, without generating so much ______as to allows your body to generate an immune response to it both in the short term as well as long term immune responses.
And that therefore, that virus can’t be overcome, but it can’t overcome by the system. So attenuation is a strategy that was developed years ago, you know, almost 200 years ago, maybe 300 years ago, that the original vaccines for pox viruses used. They were actually live viruses in this case. And now they’ve taken for example, polio, the best known attenuated vaccine is a mutated virus, and it’s crippled, and it replicates in humans, but very poorly compared to like polio, a wild polio and then you’re able to mount a potent immune response. And the same thing goes for measles and other types of viruses where they’re attenuated.
they’ve been modified in a way and of course today, and recombinant DNA technology, which is something that wasn’t available until the last 30 years now we can engineer viruses to be to do this. And so it’ll be interesting to see what the creativity of science does for things like Coronavirus.
Coronavirus is interesting been around a long time. I think it’s the largest known viruses, family, and very little is known about it. And because there are genes within that genome, we don’t we don’t have a clue what they really do. And it will be interesting to know that people will start studying this virus and understand its biology and allows us to understand his pathology, which will give us the insight we need.
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