WEBVTT Kind: captions Language: en 00:00:00.960 --> 00:00:06.880 Thank you for the opportunity to share  the data of our COVID RAPID Test. 00:00:10.720 --> 00:00:12.400 Why is it so important? 00:00:13.360 --> 00:00:20.560 Well, although we all have the hope that COVID was  going to finish quickly, currently, we have around   00:00:20.560 --> 00:00:28.560 100 COVID cases every three seconds in the world,  and someone dies from COVID every 12 seconds.   00:00:29.760 --> 00:00:34.160 In other words, we are still  here. And we are going to continue   00:00:34.160 --> 00:00:38.400 to deal with COVID for a long time,  so we need to be better prepared. 00:00:42.000 --> 00:00:49.520 Why another COVID test? That was the question  that always popped up. There are currently 400   00:00:50.160 --> 00:00:57.680 tests approved by the FDA. As you see the  majority are molecular tests. And mostly they   00:00:57.680 --> 00:01:05.120 are trying to simplify the process, they have 88  antibody tests and some of the 34 antigen tests. 00:01:06.800 --> 00:01:09.920 What is the problem with those existing methods? 00:01:11.280 --> 00:01:18.000 As you can briefly see here, the biggest problem  right now, but at least has been growing with   00:01:18.000 --> 00:01:25.760 the Omicron [variant] is there is a high rate  of false results. And this is with the PCR,   00:01:25.760 --> 00:01:32.720 which is the gold standard. And you can see  the reference here in the Hopkins website   00:01:32.720 --> 00:01:33.360 [https://www.hopkinsmedicine.org/news/newsroom/nwes-releases/covid-19-story-tip-beware-of-false-negatives-in-diagnostic-testing-of-covid-19].   00:01:33.360 --> 00:01:41.600 And with the rapid, the situation is  worse. And with Omicron, as I told you,   00:01:42.320 --> 00:01:46.720 the situation has been getting worse and  worse. And you can see on the right side   00:01:47.440 --> 00:01:53.840 that there has been calls for the FDA to recall  thousands of rapid tests from the market. 00:01:56.320 --> 00:02:03.360 Which will say those rapid, those false test  results, that means [there are] 300 million   00:02:03.360 --> 00:02:09.120 false results in the world. So we  are talking about a big problem. 00:02:11.920 --> 00:02:20.080 Why? Why so many false results? Basically,  because we have a big gap for diagnosis in   00:02:20.080 --> 00:02:29.520 this side of the curve. And we also have a big gap  for diagnosis and for the screening in this area. 00:02:34.000 --> 00:02:40.720 What is the market need? So we try  to answer that question with I-Corps. 00:02:41.280 --> 00:02:47.840 And we find out that we have different types of  hospitals, we have small and medium hospitals   00:02:47.840 --> 00:02:55.360 that are in urban and rural areas. And then, we  have the large hospital and the federally-funded   00:02:55.360 --> 00:03:03.280 for the hospitals. These hospitals on the  right side, are likely to be open 24/7,   00:03:03.280 --> 00:03:11.360 and likely to have laboratories also open  24/7, have PCR, or have created their own   00:03:11.360 --> 00:03:16.640 tests to respond to the pandemic. On  the other side, which is the majority,   00:03:17.680 --> 00:03:25.600 they are not running laboratories 24/7. In many  cases, they refer the results to other sites. That   00:03:25.600 --> 00:03:32.000 means outbreaks, that means they need to pay more  money. And every time that they have an outbreak,   00:03:32.000 --> 00:03:38.800 they have less money and, basically, they  have less funds to respond to those problems. 00:03:40.280 --> 00:03:51.760 What of it? If you look at the majority or a large  proportion of cases that are already hospitalized,   00:03:52.320 --> 00:03:59.120 they have been diagnosed clinically - 30  to 50%. It depends on where you look at it,   00:03:59.120 --> 00:04:04.000 the numbers can go even higher in  developing countries - they are   00:04:04.000 --> 00:04:07.280 diagnosed clinically because  of those false results. 00:04:10.240 --> 00:04:22.400 So I told you that means morbidity, mortality,  losses. Which to us is a big concern. And many   00:04:22.400 --> 00:04:27.840 of the small and medium hospitals  are breaking down because of that. 00:04:30.240 --> 00:04:34.480 We also collect preliminary results in  the laboratory and in the clinical field. 00:04:35.280 --> 00:04:41.200 This is one of them. This is our high risk group,  an HIV infected population. They were the smokers,   00:04:41.200 --> 00:04:47.680 so they had a dual reason to be at a high risk for  COVID. And we were located in, we are located in   00:04:47.680 --> 00:04:53.600 Florida. Florida is one of the epicenters- one  the biggest spots here in the United States. And   00:04:53.600 --> 00:05:00.000 if you see - we're following 400 individuals.  And of those 400 individuals, we have a good   00:05:00.000 --> 00:05:06.640 distribution across socio-demographics. They were  tested on average two or three times per year.   00:05:09.680 --> 00:05:17.680 During that year, they reported before that  they were in close contact with other infected   00:05:17.680 --> 00:05:23.840 individuals. Ten of them, they say that they  have clear symptoms, but the test was negative.   00:05:25.280 --> 00:05:32.160 And only three individuals were told that  they were infected, and they were fine. 00:05:34.160 --> 00:05:42.320 So, if you see this graphic, this was Florida, at  the time that we take that study, so it was 20%,   00:05:42.880 --> 00:05:48.800 20% of the population was positive at that time.  Obviously, we are talking about a high risk   00:05:48.800 --> 00:05:55.600 population, we were expecting that we will have  at least 20%, or even higher. So we really have,   00:05:56.640 --> 00:06:03.840 as I told you before, the 1% with the PCR, and  4% of them were with symptoms. So we decided to   00:06:03.840 --> 00:06:12.160 go back and do antibodies - IgG antibodies -  to be sure if those individuals were infected   00:06:12.160 --> 00:06:18.720 in the past year. And we find out that 50% of  them, in addition to these 4% [Symptoms] and   00:06:18.720 --> 00:06:27.040 1% [PCR] were really infected. In the - during  that year - with COVID, that really was better   00:06:27.040 --> 00:06:35.440 than the 20% that was going on in Florida. With  our tests, we were able to detect 60% of them. 00:06:38.720 --> 00:06:44.960 So obviously, the big question was: how we  were able to detect so many cases that the PCR   00:06:44.960 --> 00:06:52.640 antibodies were not detecting when they were doing  it [repeatedly]? And we went back with the animal   00:06:52.640 --> 00:07:03.840 models, we used the animal model to try to track  our target and do both a low doses and a high   00:07:03.840 --> 00:07:11.440 doses to be sure that we can represent those with  asymptomatic and clinically symptomatic cases. 00:07:12.720 --> 00:07:22.560 And we were able to demonstrate that our target  for diagnosis has started being heavily produced   00:07:22.560 --> 00:07:30.560 at this level, at this day - approximately the  third day post-infection. But equally important,   00:07:31.280 --> 00:07:36.400 when we check for our target, we weren't able  to demonstrate it through the entire time   00:07:36.960 --> 00:07:43.840 of the infection and disease. This means we are  not going to have these gaps, or these gaps. 00:07:45.840 --> 00:07:52.080 So what we are trying to create right now is  the 5th Generation Combo antigen / antibody test   00:07:53.040 --> 00:07:59.040 that will further increase our accuracy.  A difference - so the other test   00:08:00.000 --> 00:08:06.240 needs to be done in the lab or needs to be  done with swaps. This is a drop of blood.   00:08:07.360 --> 00:08:16.720 It will allow for early detection and will also  give us the benefit of noticing gaps. But we're   00:08:16.720 --> 00:08:23.760 using multiple entities and that will allow us  to recognize vaccine versus current infection. 00:08:25.600 --> 00:08:27.120 This is the group I need to give   00:08:28.640 --> 00:08:32.960 credit to - the rest of the team  that is helping me in these efforts. 00:08:34.080 --> 00:08:40.400 And thank you for this presentation.  I’d be happy to answer any questions. 00:08:42.880 --> 00:08:43.920 Thank you, Maria.