In this video from Motley Fool Live recorded on Nov. 12, Sorrento Therapeutics' (SRNE.Q -27.08%) chairman, president, and CEO Henry Ji and senior vice president of regulatory affairs Mark Brunswick discuss the company's three COVID-19 tests. None of the tests have gained an Emergency Use Authorization from the Food and Drug Administration yet, but the executives expect to submit applications -- or update an old application -- for all three tests fairly soon.
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Brian Orelli: OK. Maybe we could turn toward your tests. You have three different tests for COVID-19 that you're working on. You have COVI-TRACK which is an antibody test, and that would be used to see whether somebody had been exposed in the past, or maybe to look and see whether patients are developing antibodies as they're recovering. You have a diagnostic test called COVI-TRACE and you have an antigen test called COVI-STIX, which could detect the virus directly. What would you say is the main misconceptions about COVID-19 testing right now?
Henry Ji: I think the testing right now, the key is you have to give results very fast. You got to get the results almost instantaneously. Otherwise, you waiting for, it does not do the work. So you have to be instantaneous. The one we're working on, the COVI-STIX on the virus antigen testing is a 15-minutes type of results. [...] results read out. Then the COVI-TRACE is about 30 minutes for the nucleic acid testing. It's pretty fast, 45 minutes, it results the viral genomes whether you have it or not. Of course, the antibody, you can always trace it, track it, see whether you have a response, especially the IgM, you stay in the active infection period. We're working on all of them. One of the reason we're working on diagnostic is we have a scheme, a schema to solve the problem. The schema is detect early and treat timely. Imagine you have a COVI-STIX and you go through CVS or Rite Aid, or if potentially we get the approval, we could get the home use. You have this COVI-STIX, it's so simple like a pregnancy test. You go home and you test it, and then 15 minutes, 20 minutes later, you say, "Wow. I have the antigen detect positive." That's when you call your doctor. Your doctor says, well, you can pick up a COVI-DROP from the local CVS or Rite Aid and then you instantly can apply this one, if we get the FDA approved. So our idea is detect early and immediately have a means to the treatment. If that works, if you did the, let's say, COVI-DROPS, you do the intranasal drops, and you follow with COVI-TRACK, you follow with COVI-STIX, see whether your virus is cleared and your own antibody kicks in, that's what we wanted to do, not only detect and diagnostic; have a treatment immediately available. Meanwhile, you can track it. It's like a companion diagnostic with [...] therapeutics altogether.
Orelli: Where are you with COVI-STIX in terms of getting enough data so that you can apply for authorization?
Ji: We are very fast moving on with the COVI-STIX. I'm not going to quoting specific days. We are talking about that we're going to apply for EUA approval as soon as possible.
Orelli: That's EUA --- Emergency Use Authorization?
Ji: Yes.
Orelli: Then you applied for COVI-TRACK, the Emergency Use Authorization for that, on June 10th, and you still haven't heard back. What's the status of your application?
Ji: What we submitted, it's a first-generation type. Right now, we have next generation, much more stronger, let's say, sensitivity side, and probably about a tenfold. So right now, we're focusing on the next-gen which is the COVI-TRACK. We are getting all the product making and doing the testing, and with that, we think we're going to be having one of the best-in-class type of COVI-TRACK for antibody measuring, which is very critical. Because if we have our neutralizing antibody through the intranasal or IV, you want a very accurate COVI-TRACK to follow the antibody. Meanwhile, you want to manage the virus, we have COVI-STIX. We are very, very happy with the results so far. We believe we're having the best-in-class right now in the viral antigen detection. Of course, we're working on the COVI-TRACE for nucleic acid, which is a rapid test as well.
Orelli: So was that COVI-TRACK Emergency Use Authorization application withdrawn then for the first generation?
Ji: Mark?
Mark Brunswick: What we've told the agency is that we are going to supplement our EUA with the next-generation.
Orelli: Do you have a timeframe on when you're going to submit that information to the FDA?
Brunswick: We anticipate very soon. But it takes collecting clinical samples and getting patients to agree. It's very hard to give exact timelines on these types of things.
Orelli: Then your third one, the COVI-TRACE, that's the standard detection with the PCR, I'm assuming. Where are you with that?
Ji: What we did is we collected clinical samples. We are doing the final final, all of the sample testing. So far, we are pretty happy with the data, so I think we will be able to submit it very soon as well.
