Craig Rouskey: Thank you Sean. I’m Craig Rouskey, the CEO of Renegade Bio. I’m really excited to share with you how we are bringing fast, accessible, secure triage for COVID-19 to the community at large. So to start off, this is our team. I have my master’s in molecular biology and immunology and have worked pretty extensively throughout the field. And Gabriel Paulino and I worked together or met each other in IndieBio Class Nine. And when the pandemic was announced, we immediately jumped to action. We brought on Solu Ribeiro who manages our collections. And together the three of us have formed a team of more than 20 physicians, scientists, programmers, business leaders and advisors.

Craig Rouskey: Here is a map of our activity over the last two months. March 11th, the pandemic was declared, the CDC released their primer and probe sequences. By March 18th we were incorporated as a public benefit corporation. March 24th we completed 120 research tests in San Francisco and on March 28th we were recruited to New York City to start testing first responders here. April 15th was a big day for us, it was the first day we released our results in New York City and tomorrow our first EUA emergency use authorization will be filed.

Craig Rouskey: So what do we do? We are a full services laboratory. We help organizations collect their samples through logistics collections. We operate and built our own laboratory information management system to track samples and data through our lab from the patient through the lab and back out to the patient. We develop assays and optimize other assays that have been created in the case of SARS-CoV-2 and then we perform those assays in our CLIA Laboratories in New York City and in Oakland.

Craig Rouskey: So what is the principle behind the Renegade XP assay that we developed for COVID? So basically what happens is the sample is collected either a nasal pharyngeal swab, an oral pharyngeal swab or even sputum is collected from the patient. We do a pretty quick RNA preparation. That takes about half a minute per sample. That preparation is then reverse transcribed into what is called cDNA, complementary DNA, and amplified by DNA polymerase. As that DNA polymerase sort of chomps along the single strand of DNA, it releases a fluorophore that is attached to a probe and as that fluorophore is released, it is released into the assay matrix and we detect a fluorescent signal on our qPCR machine. Specifically our assay is targeting one gene in the SARS-CoV-2 virus that is the nucleocapsid gene. And we also look at RNA SP, which is human RNA, just to assess the quality of the RNA that we recover from our RNA preparation stage.

Craig Rouskey: So our emergency use authorization data is being submitted tomorrow, as I mentioned. The analytical specificity of our test is 100%. What that means is when we say we detect SARS-CoV-2, we detect SARS-CoV-2, nothing else! The analytical sensitivity is the limit of detection of the assay and we can recognize down to 10 copies at the current moment in our assay. That’s 10 copies per microliter. Our diagnostic specificity is the rate at which negatives are detected as negatives. So also a measure of false positives, and we are at 0% false positives or 100% diagnostic specificity. The diagnostic sensitivity is the ability of our tests to detect how many or the number of positives at the limit of detection. And there, we’re at 95%. And you can see in the data in this experiment that I included here. We have one out of 20 that didn’t respond to the test at the limit of detection. 

Craig Rouskey: We are four times as fast as the CDC method. We do a minimal RNA preparation, one of the big complaints with a lot of the qPCR, qRT-PCR assays is that there is an extensive RNA preparation time that takes about five minutes per sample. Our RNA preparation takes half a minute per sample, which allows us to run 96 samples in two hours, which is amazing. So per day per machine with a 96-Well Block, we’re actually able to run 1,200 samples a day at our current capacity.

Craig Rouskey: So we see our assay as a way to reopen the economy. We’ve begun partnering with organizations to administer certificates of compliance through their occupational safety and health departments. And we’re also talking about immunity passports. The World Health Organization has gone back and forth on the immunity passport. As we further discover the role of antibodies in this infection. That is, are they protective or not? One of the issues that we’ve heard a lot about immunity passports is the HIPAA issue. How do employers have the right to know their employees’ status, and we refer to HBV or tuberculosis. If you are a teacher, a nurse, a doctor, et cetera, you’re required to get these tests and have your results reported to your employer. So it would be no different for SARS-CoV-2.

Craig Rouskey: And for context we’re here in New York State and currently New York State is running about 40,000 tests per day or trying to get to 40,000 tests per day, and at our current capacity, that’s three machines running the tests that were developed here at Renegade Bio. That’s 1,440 tests per day. That’s 3.6% capacity and the Renegade Bio capacity in 10 days, that is the number of tests per day will be 5,760 tests per day, representing about 14.4% of the total New York State capacity.

Craig Rouskey: So the way we see this working, opening up the economy is basically having an employee or a patient tested for virus. If they test positive for virus, they would be quarantined for 14 days, at which point you would retest them for the virus. If they’re positive, they go back into quarantine and continue in that loop. If they’re negative, they shift over to the antibody tests. And we are working with partners to bring antibody testing into our clinical labs as well. And if they’re positive for the antibodies, they’re considered immune. If they’re negative for the antibodies, they’re considered susceptible and that information would be reported to the OSHA Department or to the patient through an immunity passport. So yeah, that’s what we’re doing, if you or your organization would like to get tested, please feel free to reach out to me, craig@renegadebio, I’d love to hear your thoughts. Thank you.

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