Below is a 8 minute video and full text summary of the SalivaClear solution as presented by Mirimus Labs Founder and CEO Prem Premsrirut at the Virus Project Contagion Conference.
Full Text version of presentation. Lightly edited for clarity.
Mirimus Labs CEO Prem Premsrirut MD is a pioneer in RNAi therapeutic design and CRISPR/Cas9 gene editing technology implementation for preclinical studies. She received a B.A. in Molecular Cell Biology and Biochemistry from UC Berkeley. She is also founder of the Mobilizing Foundation which is committed to the eradication of COVID-19 and the prevention of future pandemics through collaborative scientific research and massive surveillance testing.
Prem Premsrirut MD. "Thanks again, for having me on the panel on allowing me to present today, it's such a pleasure to showcase our work.I think one of the things as we spoke about during the panel was that our company pivoted right when COVID hit, to diagnostic testing. Even though we were never in the infectious disease area, what we were prior to this was a genetic engineering company, we actually had to engineer animals, genomes. Out of that we were doing thousands and thousands of PCR tests already, Doing PCR was our mainstay. It was what we were used to, so this was really just a pivot. And we were a lab company that was able to take high throughput processes and make them more cost efficient and effective.And so this for us was really the goal of why we started this it to begin with. Our mission here is really to provide the high quality standard testing at low cost, and to enable schools and workplaces to do testing. We do this on saliva based pool testing, it's high throughput, high sensitivity, and the sample collection is simple, it's non invasive. And again, we can actually retest the solution. What is really key to testing is the turnaround time for this, the results in all levels of testing here. Our turnaround time for us is about 24 hours.Pooled TestingSo what we actually do is we cohort and do pools of 24, organizational base pooling, and we then allow people to submit samples, individual samples, and they can group them together and allow us to test them. This works really well rather than random pooling. We actually ask organizations to group, either if it's a school to group them by classrooms, to really group them by people that interact together. This really allows us to then look at where's the outbreak is happening. So the testing really is designed to have those that come into contact with each other tested together, you know, you don't see positivity across the board, what you do see is you do see clusters of positivity. We had for example, a boarding school, and they had had one positive case. They were doing random testing, and they had one positive case, and they wanted to now test the entire population. And so we advised them actually to group those that live together. So out of about 400 people, we were able to pull out 10 positives, and they all lived in the same dormitory. So we didn't have to retest every single pool, because having that across, we actually retested those that were in the same group. So if the pool is negative, we then go ahead and just consider everyone in that pool negative. If it's positive, we're able to then de convolute and reflex down to identify the positive individual. So we will group them into smaller sub pools, and then we'll be able to then identify which of the two are positive and so this will then go into a physician order and they were able to get their individual diagnostic test.So just to illustrate how the testing it's effective and high throughput, you we are taking 24 individual samples combined to one test. If you were asked to have to conduct tests and all of these individuals, this is what it would look like on a regular basis. Now, when we do this, you know, whether it was about cost or not what we are also doing is conserving reagents, consumables, everything related to testing. We are in such a state of scarcity of supply chain issues and not having enough testing reagents that for us this is really is about the way to test and get the diagnostic test to those who need it most. If you're identified in the pool, you undergo further diagnostic testing, but otherwise, we're able to clear all of those individuals that are negative really early on.Low Cost High Accuracy TestingSo what do we charge? What we really wanted to bring low cost testing, we just increased prices for corporations, but we're doing a "robin hood" (rich pay for poor) style. All of our schools are on a reduced rate of about $15 per person. We do have another reduced rate for public schools as well. For corporations, we asked them to really help us help the public schools. This is again a robin hood model where we're asking about $20 per person and we give back to our foundation (Mobilizing Foundation) that can help to then subsidize testing for public schools.If there's a positive pool, there's also another retest, and so forth. So, you know, we actually have seen about, about, on average, each organization has to reflex about one to 2%. On the high level, it's about 3% to 4%.Simple Kits and ProcessThe kits are very, very simple. It really is just spitting into a tube. You are given a vial that's barcoded everything's done in anonymous basis, you then can just open up this straw, put it into the tube, and then submit your sample and send it in for shipping. We contract with large organizations testing everyone, usually on average, on a weekly basis, some of them more frequently. The key for us was a non invasive approach, something that allowed people to self administer, to be trained to do the sample collection and easily provide a sample. The web portal that we provide, will then give results in a pooled base. So you'll be able to see which pool is detected, which pool is not detected. And it will list all the barcodes tested within this pool. This system really is appreciated by a lot of parents, that, you know, we are not tying anyone's name and personal health information to their sample, everything submitted to our lab is anonymous.The Science of Saliva TestingJust to give you some sense of the science behind this. We could take a positive saliva sample, and we could dilute it more than 200 fold, and still always detect the positive case. And so you can see that if you take an individual and you were to pull it in, this is a very strong positive. But if you're able to pull it into groups of 8, 16, or you know, even up to 96, you can still detect the positive.High Confidence in ResultsIf we take a weak positive sample, one of the real borderline that has you know, very, very low viral loads, even when you take that sample and pull it into a pool of 24, you're still always able to detect 100% of time, that one positive sample in that pool. This gives us a lot of confidence of the testing strategy. We have now tested over 250,000 samples in our laboratory, we've had more than 100 schools, of businesses and so forth across the nation. And we've had no reports of any one coming back saying that we have missed a positive case. And so we feel very, very confident with our approach. You know, just in some case studies we have had people tested positive through our strategy, but then went to get confirmatory antigen testing through rapid tests and came back negative. So we advise them again, please, do a PCR test, and lo and behold, it became positive. And a couple days later, they also had symptoms. So we do believe we were catching people extremely early. And that we're able to then pull them out of the situation from an environment.Brett Johnson (moderator) Thank you, thank you Prem, it's really good inspirational effort that you've got going there. And so we'd love to collaborate with you in any way that we can to support that. So I know one of the big things that you've been keen on, is what we can do in schools. And so I think, I think there's a real need for an effort to create an organized approach to schools. So I know you've learned as much about dealing with schools now as probably anyone. So we look forward to doing a focus session on something like that in the future, if you can, if you can join us for that.Prem PremsrirutAbsolutely. You know, it's, it's a combination of the fact that, one, we're able to provide a safe environment, make sure no one you know, that has COVID-19 is entering the building, the person who not you're sitting next to all day long doesn't, it gives parents, students, everyone that confidence to really go back to school, you know, for hours on end next to people. And I think it's really that mental health as well, you know, that anxiety of having to be in there for the teachers, for everyone, the staff, facultyWorking with the schools has been, you know, extremely rewarding. It's also taught us a lot, you know, the positivity rate throughout the schools is much, much lower than anyone anticipated. And in fact, you know, we do see sometimes that having kids in school can change behaviors, you know, they are actually more strict about keeping masks on staying socially distance keeping proper hand hygiene. And yet when the schools are actually out of session, we tend to see spikes in positivity. So, you know, it does say something to schools having an effect and being able to help our young youth know, how to, you know, again, wear masks and, and practice proper social distancing. END OF VIDEO