 Hi, welcome to International Hawaii on Think Tech, where we showcase local import and export companies and the trade industry. I'm your host, Cindy Matsuki, and today we're chatting with Ernie Lee of First Vitals, Health and Wellness, an awesome company and an FTZ 9 tenant. Yay! Hi, Ernie. Thank you so much for joining me. Hello, Cindy. Thank you for having me and welcome. Good. So First Vitals, I know I've run into your team across the hall, but can you briefly explain what your company is and how you got started? Sure. Well, First Vitals is a healthcare service provider that what we do, we provide support to primary care practices here in the state of Hawaii. So our staff consists primarily of nurse practitioners, certified case managers, pharmacists and care coordinators. So we started back in 2012 with a federal grant from CMS, which is the Centers for Medicaid Medicare Services. And we were charged to provide remote patient monitoring, you know, for high risk diabetic patients here in the state under the Medicaid Quest program. So we got established here at the trade zone, you know, we were importing Bluetooth enabled glucose meters as part of a remote patient monitoring program. So having done that, we're being able to, you know, interact with the federal qualified health center, you know, deploying these glucose meters to this high risk population and be able to connect to a smartphone or a tablet and be able to obtain their glucose readings on a real time basis and provide that information to their healthcare provider. And then they're able to intervene at the most appropriate time. So that lasted from 2012 to 2015, then after that we commercialized our operations, and we became certified credentialed with the insurance plans like HMCA and UHA. And the remote patient monitoring platform is continuing on, you know, serving, you know, the high risk population, and with the pandemic it becomes to be very useful to be back to people, you know, remotely. That's awesome. The timing was great that you guys are doing that. Yeah, it was. I'm glad that's still going. And so what I really wanted to cover now that we know that why you're in the foreign trade zone, you have a new project that's really relevant to Hawaii and the pandemic recovery. And it's regarding testing for antibodies produced by the vaccine for COVID-19. So how did you kind of get into that and can you briefly explain the service. Well, originally we were tasked by the state of Hawaii, as you know, under the Safe Travels program, you know, they were looking at how to verify CDC records. So one of the tasks that we're given to first virus was to look at, you know, how can we verify these CDC vaccination cards. So doing this exploratory and discovery phase with the state, you know, our clinical team asked the main question as well. It's great to be able to verify a vaccination card. But what we really need to know is, you know, how long would an individual be protected, you know, from COVID if they've been vaccinated. So that set us off in moving in next direction, you know, after verifying a vaccination card, you know, how long would that person be truly be protected based on the vaccination. So we know that we don't know how long community will last from your vaccine. But we also know from the CDC is providing guidance that was going to be forthcoming in next few weeks, looking at, you know, the people who are immunocompromised, or elderly, or even healthcare workers, that were vaccinated in early days back in January, February or so, they're going to be coming up, you know, for consideration if there's going to be a need for a vaccine booster. So in able to determine that we need to kind of look at, you know, what are their antibodies level, you know, that has passed since time that we see their second dose of their vaccine. So then the high risk individuals will be able to be prioritized in for their, you know, booster shots. So we're looking at the ability to deploy these tests, these are known as neutralizing antibody tests, looking specifically for these type of antibodies that are generated from the vaccines, the Moderna, the Pfizer and Johnson and Johnson. So they can quantify and measure the amount of antibodies present, because we all know that antibodies will wane over time. So we're looking at deploying this and be able to scale this on a large population base so that a lot of people can be tested and prioritized if the wind boosters come to market. Wow. And then, is this something that you would do human trials on to test to see the efficacy of the results. So this assay that we're working with has already received FDA, EUA, which is the use authorization is the first one in the United States to be approved. Wow, you're neutralizing antibodies. So right now we're in the process of validating this test. So there's a couple ways as you know with most antibody tests or lab tests is based on blood or serum. We're looking at deploying a simple way of collecting a blood sample is through a finger stick. So just maybe three to five drops of blood that's collected that can be sent to the laboratory. So it can be tested to determine both whether or not you have antibodies resulting from your vaccine and the quantity, the amount of vaccine or antibodies in a period of time. So we're looking at to be able to deploy this on a large scale for the population. So you don't have to go to a laboratory, you know, to get, you know, blood drawn and so forth because that's some resistance in the population. Wow. And then would you initially start with Hawaii. And then we are. So what we're looking at if you recall back in January, the priority list of people that were vaccinated, you know, where the elderly people, the congregate living facilities, they age five and older, you know, people with the, you know, compromised health conditions. So we will be going back to that population and working with their care providers, you know, as to determine when and if they need to have a booster. Because we anticipate availability of booster shots, maybe at the Q4 at the end of this year, preparation, you know, looking to see, you know, which segment of the population will be suited for a booster. And not, you know, not a general call like everybody should be in the case of not because they could be, you know, well protected for years, especially young and healthy. But the ones that are at risk are the ones that we are most concerned with to make sure that their antibodies to try to sort of level to protect them. And then these at risk people, are they the one like has it been shown that their antibodies decrease faster at a faster rate than other people? Yes, there's studies have been done as people like transplant individuals, you know, individuals, they have their studies already looking at the efficacy of the vaccines and baseline measurement. There's a study on the Pfizer vaccine that was demonstrated that people over age 80, the amount of titers or the amount of concentration of antibodies was much lower than a person of their age as well too. So maybe just from the initial vaccine. So even though you've heard about like Pfizer or Moderna is 95, 94% efficacy rate. Well, what happens is 100,000, you know, that's like, you know, what 5000 people may not be effective, you know, we're protected with Wow. And so this is a way of measuring this. In the early days, you've heard of not serology or antibody tests that were out in the market, but they were looking at, you know, we're called, you know, separate type of antibodies not neutralizing antibodies, you know, so it wasn't specific to the vaccine because it wasn't developed or marketed at that time. So now, neutralizing antibodies tests are specific for the vaccine. Oh, was a previous test to detect more like if you had had COVID. Yeah, you still have antibodies. So you originally with the antibody test that first came out when the pandemic look and the controversy about that it was that it's being used inappropriately was. Oh, you've been vaccinated not vaccinated, but you've been infected. And that they're looking for antibodies in the positive or negative. But for a population health perspective, you really want to look at the people have an active virus, because they're the ones that are affecting other people. You want to catch it early. And then the question is by some of those antibody tests that were out in the marketplace, they didn't seem to be very accurate or reliable. So they failed, you know, considerably. They were not effective at the time. That's why there was a stop to not those type of antibody test because they were not very specific. New way of, you know, measuring neutralizing antibodies based on a vaccine is much more effective strategy in managing and, you know, measuring the antibodies related to your vaccine. Wow. And how accurate are you guys able to get. So based on the assays and against the gold standard, they say is 100% sensitivity and also 100% specificity. So there's a report that can be shared so we're excited about that. So we compare against a live virus is what was the standard against but you can't do live virus because it's very dangerous. You know, testing, but there are studies that's already been published. And that's what could be releasing to the health care community, you know, for their review as well too. Wow, that's exciting. Yeah, I think it is. You know, once, you know, people understand this and be able to read the literature to health care community and be able to assess, you know, the, the efficacy of such a test in this population. So that's something that we use for the general population for all we're not suggesting that, but for people that can mention a immunocompromised it might be ideally suited for them, you know, to measure the levels and when and should they have a booster, you know, shot time. So like once it starts rolling out like, how would, how would it, would it be every month they would get a test or more frequently. And also be on the guidance of their health care provider. The ones that mentioned the high risk the elderly and so forth that we'd be going to those facilities and working with their primary care doctor, administering this test to me I only need to have one test to take a measurement. And also that is up to provider at that point to order another test if needed or to say, well, you're going to need a booster, you know, we'll go ahead and get it. So it's not that you're going to need it, you know, every month is different. You know, the way, you know, how the antibodies affect our bodies and how long it lasts and so forth, it varies from person to person. Wow. So that's why this test is so important. Right. At least it gives you a snapshot in time. That's their measurement there you may not need to boost it right then. You know, in some future you won't test again at three months or some other time. Like you would, you know, a reference. Got it. So you guys planning to roll it out at the same time the booster is available. So maybe like you for this year. We're looking to have this available in month of August. In advance of, you know, the announcement for the manufacturers of the availability of a visa and for the guidance from CDC about the situation of the booster shots. So part of this is education. You know, to the healthcare community. So they have an understanding what are neutralizing antibodies and how this test and both based on qualitative and quantitative. You can understand and read the literature and see how they can use it most appropriately. Maybe could you give us a simple explanation about neutralizing antibodies. Yeah, what neutralizing antibodies basically, you know, we get vaccinated is you've seen that spike protein, you know, that comes up. So it's like a block in the back. The antibodies is a block against the virus entering your body to cells. So those are how the vaccine works isn't basically an effective call on neutralizing antibodies that neutralizes the virus from entering the body. Hmm. Got it. And then you guys working with the state, or is this going to be private to, I guess with the clinics and with the care homes, would that be something they wouldn't take on. Yeah, it may be at some point depends on your department health, you know, as to, you know, their position. You know, testing and so forth to provide some guidance to the community at large as well too. I'll be going to the care homes, you know, to the jurisdictions to the physician offices and let you the literature and give us appropriate for their patients or not. Got it. Do you, I mean, if you don't mind my asking, do you have a price range. You don't have to answer. I have a good question right now because under the public health emergency, you know, serology or antibody testing is covered. Oh, so we anticipate because it's great, but there's a medical necessity to kind of identify the adaptive immune system based on your vaccine that you that it seems to be a qualified medical necessity, especially for the elderly and so forth, and then cover so as you know with Kobe testing during this whole pandemic been covered at no cost to the individual. And this is what happened only during the public health emergency. We anticipate the public health emergency will be extended, you know, perhaps for the rest of 2021. If that's the case that the cost of the test should not be an issue for individuals, you know, seeking this. Basically, it's like Kobe testing that we accept whether the reimbursement from Medicare or the insurance plans and that will be it and that's the arrangement that we have the laboratory. That is good news. Yeah, because in the beginning don't want to make a cost of barrier. Yeah, yeah. Especially rolling out as a new, a new test. Right, exactly. We're going to take a quick break. This is International Hawaii on think tech, and my guest is Ernie Lee and we'll be right back. I'm Mitch Ewan host of Hawaii, the state of clean energy on think tech Hawaii. Hawaii the state of clean energy is about following the many clean energy initiatives in Hawaii. Hawaii the state of clean energy appears weekly on think tech Hawaii at 4pm on Wednesdays. Thanks for watching our show. We'll see you then. Aloha. Hey, welcome back. This is International Hawaii and your host Cindy Matsuki. And today we are talking with Ernie Lee of first vitals health and wellness and we're talking about their new programs to help Hawaii recover from this pandemic. And we spoke about a new antibody test. And then you also have another project. We're in partnership with human API that's also related to the pandemic initially. And could you explain a little bit about this program and how it's going to help Hawaii. Sure. Going back earlier, as I was mentioning about verifying, you know, CDC records or cards and so on. They're vaccinated at different facilities. So human API is an organization based on the word API is the application programming interface is electronic means of extracting data, you know, from medical records. So we connected with them to be able to access based on consent and permission from the consumer patient, the medical records to verify their CDC vaccination information. So that was used and what we were doing part of the verification process is verify that record, and then issue a digital health pass. So this digital health estimate heard about is controversial in certain markets, of course, you know, it says that be able to be used to access public venues that concerts events or even travel. So besides verifying your CDC record, your vaccination record, you also need to have a mechanism to be able to display that and not display all your personal health information, the status of whether or not you have been vaccinated or not. So human API that we have worked with, be able to not only locally here in the state of Hawaii, but on the mainland as well, they're connected to the main, you know, pharmacy chains like CBS longs, Walgreens, clubs, Walmart and so forth. So that be able to verify these records and for us be able to issue these digital health passes. But now with what we have just discussed earlier about the ability to provide, you know, neutralizing antibody testing. We're also able to add this as part of the future of the digital health pass so not only going to verify your vaccination record, but then also look at, you know, how long is that vaccinations did for. Wow. So that's that so that's the add on and our partnership with human API help us to at least reach out to the various data sources to verify vaccination records nationally. Then with that, that's only a part of the, the use case that we're working with is so right now because it's COVID related. And that's specifically, you know, verifying records and then the status of, you know, antibody testing, but the bigger picture the longer vision is the ability for an individual to own their own personal health record. A lot of people now aware of this but effective this year, the government mandated that individuals who wants access to their medical records, those health care providers must provide them access or copies of the records. So if you think about this if you're an individual and you have a primary care physician and you have a number of specialists, and you go to clinical labs DLS, you go to the lungs for your pharmacy. You have medical records all over the place and then you'll cover by HMA as an example, UHA, and they have your claims data, but you're not able to have your own personal health record but making requests to each of these entities that bring all that data and into one longitudinal, you know, personal health record. So be able to help you manage your medical history, and also allows you to share that information, you know, with other health care providers, you know, based on your requirements. So this way you'll be able to have access to all your medical information at it. You know, basically. So this project that we're working on, but that's a long term project and trying to pull all that together, but having this collaboration with human API as part of our partners that we're able to work with them and design, you know, the personal health records for you know individuals. So were you guys helping verify for the inner island travel or people could. So what happened there is that the safe travels decided just to upload the CDC card into the system, and then at their call, they can pull random checks. You know, I see. So it wasn't like they're doing everybody. Right. So then, you know, doesn't have an issue, you know, backup at the airport, things of that nature. So they were able to upload and find that it wasn't a lot of, you know, fraud or, you know, forged documents or anything at this point, you know, but the thing is the ability to do an audit and look at the records. And now the Department of Health, you know, has stood up their immunization registry. So they would have a data source, you know, for safe travels to be verified. So at the beginning of the year, there was that as you know in a state where we didn't really have an immunization registry, you know, for its residents. Oh, I can. I'm glad I'm glad that that's where we're moving to. And I can't believe that it's only been this year where you can actually get access to your health records like you would think that would be things intuitive that you would be able to access at any time. But the issue is, you have to write it the old way with that you have to make requests in writing each one and they will send it to you like, you know, paper copies. Like a hard copy. Right. So the way today is based on interoperability able to extract via a data extraction from matter into, let's say you have a personal health record and with its different modules for like your medications, your immunization history, your lab test results. All that would be fed into the platform your personal health record digitally. So you have to, you know, it's great. Get all your records based on paper versus disability to have it electronically. So that what happens with all these medical providers, they must be able to provide it to you electronically. There's a lot of, you know, third party applications that are out there that even at Apple, if I seen their health kit, you know, that they have, you know, on their platform that you can pull medical records as well to this is very similar to that, that you can you know, resources available to an individual and how you are and manage your records and which part of your trust and what you're going to use it for because you can limit in scope. You know, we go back to COVID and all you want to know is to have an immunization history. And like most people today didn't, you know, recall their last, you know, tennis shop. So we just go get another one. So this will be able to manage this and then be able to keep it updated and take it with you. Yeah, and you can check it from anywhere. Yeah, absolutely. And they can share it with you with any, you know, party or even for emergency use as well too. You know, the emergency departments be able to access different use cases, you know, and then also for like, if you have a care plan, you know, that have a number of different, you know, care providers and managing your chronic conditions, you know, to manage this effectively is the medication history, because you can share that under permission rights, Asian history, your lab test results, you have consult with dieticians and those notes can be shared with others as well too. So I think there's a future whereby individuals, you know, going to be in control of their health records and manage them effectively and seek the most appropriate care. And then also to be better transparency, because part of this ability of data exchange, you're also going to know pricing. Oh yeah. Because right now we're in a third party payer system that times you get services you don't really know the true cost of it. Until you get, you know, a bill. Wow. You know, you know, benefits and the payments that were rendered. Oh, so that's all going to be in this. Interesting. So that's the future where these personal health records can be getting and where the individual consumers will be in control. That's great, especially when you're getting medication and prescriptions from different specialists, and that's really important that you know what the hard thing about medication is to have you know as you know medication reconciliation. You can be prescribed by your primary care and specialists, you know, you have multiple specialists, you know, who's going to coordinate and recognize that they're not interacting with one another and most current record of all your medication who has that. Well, it should be you taking it or not. Right. So that's then if you control that then you can share that information, you know, with your health care providers, so they can see it much better. And so, right now your partnership with human API is just for the vaccine verification. And then when is this other part going to. That's all part of our service model is all inclusive that we can do everything just writing out the strips as to what other data elements that we want to call it. This really went to affect, you know, April 5. It's when this new law went to that basically were mandated. So that we've been working on this but then with these COVID initiatives, you know, we get, you know, pulled into that direction. You know, so now, you know, just trying to prioritize, you know, doing, you know, but at the lot of the challenges that providers know that they need to release this information. But now that we're not ready to release the as well too. So it's going to take a while. Yeah, but they're all working towards that they know what needs to be done. And the different parts of the requirements are established by the mandate. So it's not like everything what it wants, you know, pieces of it. And it's going to be like subscription service or training on the provider. So it's the simple form like in our business model. If you want to manage your records, we will go up and all these records for you, and it could be a subscription model, you know, updates and the things of that nature. So it'd be fairly affordable because the reason why it's all electronic. So we have your connection, you know, to the labs or, you know, to CVS longs as an example. There's a transaction gets updated automatically. So it'd be very cost efficient so we don't need to do any manual processing was connected to what it says these apis. It's going to be very affordable so it's not labor intensive as the old days to be asking for your medical records. Yeah, you know, I have to like write it down for you. I'm going to get out to get all this paper then we're going to do. Yeah, that would be so great I mean it sounds so useful. Yeah, watch for that that's going to be, you know, forthcoming, you know, by in the super early next year you can see a lot more of this. That's so exciting. Very good. And I can't believe you guys are right down the hallway. No idea, you guys are doing all this that's so great. That was great being at the trades on here we just love it. The people here are great. The facilities wonderful. The warehouse is ideal. So great for all these years. Yeah, no, we're grateful to have you here. So, we are going to leave it there. You've been watching International Hawaii and think tech Hawaii. We've been chatting with Ernie the first vitals thank you so much for sharing your time with us. Sorry, thank you so much. And thank you so much to our viewers for tuning in I'm Cindy Mutsuki and we'll be back with you in two weeks with another edition of International Hawaii. See you next time. Thanks. Okay, thank you. Bye bye.