Franco Goytia: Thank you for introduction, Sean. So my name is Franco Goytia, I’m co-founder and CEO of Caspr Biotech, we’re developing a portable molecular diagnostics platform. Right now focused on taking to market our diagnostic solution for COVID-19. So molecular diagnostics today is mostly limited to centralized labs with trained personnel and expensive equipment. And what we at Caspr are doing is shifting precision molecular detection from the centralized lab closer to the field. And by the field we mean closer to the patient, to a hospital, point of care, clinic and even the pharmacy. And we do that through CRISPR, so many of you might know about CRISPR, mostly associating it as a gene editing technology.
Franco Goytia: While the core ability that CRISPR biotechnology brings is for its specific identification of DNA or RNA sequences with great simplicity and ease of use. And that’s kind of what CRISPR has been all about in its natural form. And at Caspr, we discovered another CRISPR-Cas12 enzyme from unpublished metagenomic data from extreme environment, which is not only very different from the ones of the foundation and institutions, UC Berkeley, Broad Institute, but also has a differential activity in terms of its performance in specific conditions which we leverage for our diagnostics purpose. So this enzyme is basically a platform in which we can detect various kinds of samples, blood, saliva, swab, plant tissue, even materials and the tech for specific viruses, bacteria, genetic mutations, and human GMO in this accessible, fast and precise way.
Franco Goytia: And this has been the focus of Caspr since the very first day that the company started in 2019. We were part of IndieBio batch eight, and we’ve done validations for up to 2022 targets. And obviously when COVID-19 emerged we quickly designed our RNA guide on our system on detection of SARS-CoV-2. We did initial validations with contract samples and published a preprint about that. And then moved into the valuations with clinical samples. In terms of the products that we’re developing using this technology, using this enzyme these are two main solutions. One which is the most immediate, which we’re soon to take in for FDA EUA for which we already have kind of our production pipeline in place is a CRISPR test kit. So this is basically a lyophilisation of our CRISPR enzyme coupled with an isothermal amplification enzyme preconfigured for SARS-CoV-2 detection and with a readout enabled in a lateral field format.
Franco Goytia: So this is of high value for that instance of point of care diagnostics of SARS-CoV-2 in a point of care in hospitals basically. And the second solution that we were developing is our phantom device, which integrates our CRISPR-Cas enzyme in a lyophilized format into paper into this paper cartridge. And this is coupled with the device, which the device basically provides some heating components. And with this solution you’re able to perform a fully automated sample to resolve detection for COVID-19. And these are kind of the two initiatives that we’re right now working with. In terms of the value proposition of the technology and the product itself for COVID-19, is the possibility of detecting in less than 45 minutes, in a direct from sample format using a direct license buffer without the need for RNA extraction.
Franco Goytia: The ease of use of being able to detect without having to use a PCR equipment or an expensive equipment or external reagents but rather with a readout which is simplified to a lateral flow and with a sensitivity and specificity, which is comparable to what is currently being performed in labs with qPCR. And these are our most recent results from a clinical validation that we’ve done with the Health Ministry of Argentina. Working out with 36 samples, extracted RNA from those samples in which we had 100% sensitivity and specificity both in the detection on fluorescence plate reader as well as with lateral flows. And this is the equipment that is needed to perform our Casper CRISPR kit, which is basically tips, tubes, a micropipette and a heat block. So it really decreases the burden of needing qPCR equipment or needing external equipment, to components which can be bought for less than $300, $400.
Franco Goytia: Right now we have four ongoing pilots including two health ministries such as the Health Ministry of Canada, as well as the Health Ministry of Argentina. We’re in conversations with various governments for the possibility of direct purchasing of our kit, which would be kind of our commercialization strategy at the very beginning. And in terms of our timing to market and the milestones that we’ve achieved so far, we’ve done the validations with extracted RNA from patient samples as I showed you before. We already have contract manufacturing in place and have set up the supply chain for the key components of our kits, including our CRISPR-Cas enzyme that we manufactured internally at scale. We’ve recently done the lyophilisation and the testing for the stability of our components of our kit with our lyophilisation partner.
Franco Goytia: And we’re right now in the process of doing our clinical validations with our optimized and finalized kit with our partners. Now the only testing for the application in extracted RNA, but also rather in the direct from sample format with the latest buffer for which we already have some initial results. And we expect to do our FDA EUA by late May or beginning of June, and through our contract manufacturing partner and our supply chain that we’ve set in place, we would be able to quickly ramp up our production for an estimated output of two million monthly tests by August of this year. So very quickly. This is a little bit about the team we’ve grown very quickly from being six, seven members at the end of 2019 to now being a team of 24 people full time. And we’re in the process of raising to accelerate our time to market. So thank you for everything.