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Lilly Reid - December 11 VIEW RECORDING - 16 mins (No highlights): https://fathom.video/share/y96rHqSTaBF721dzvzP5HrX6Qf6pUKjZ --- 0:00 - Andrew Hartmann (UTAK Laboratories) On mute. Hey, good afternoon. Good afternoon. 0:05 - Reid, Lilly A. How are things up, everyone? 0:14 - Andrew Hartmann (UTAK Laboratories) Can you guys all hear me okay? Yeah, I can hear you fine. Perfect. Are we waiting for anyone else, or is this the team? No, I believe this is everyone. 0:28 - Reid, Lilly A. Awesome. Well, I appreciate you guys hopping on a call. 0:31 - Andrew Hartmann (UTAK Laboratories) think you had already spoken with Aline, and she let me know you guys are looking to get some serum, and it sounds like we want it free of several viruses. Is that right? Yeah. 0:45 - Reid, Lilly A. So we are currently having issues with the negative control that we use for our hepatitis and syphilis testing, and we are just looking at alternatives of what is, of um, available That's to We do use the Abbott Architect slash Alimity platform. So we, and we do currently use UTAK for our DOA testing as well. So we are very familiar with the process of, you know, getting the sample, testing it, and then distributing it to the entirety of the sites. So we probably would have about five hospitals worth that would be using this serum negative that we would be talking about today. Gotcha. Do you mind if I ask, what are you guys currently using? 1:30 - Andrew Hartmann (UTAK Laboratories) We are currently using the ViroClear from BioRad. 1:33 - Reid, Lilly A. And what kind of issue do you have in there? They, I don't know if they had a manufacturing change or something, but currently the ViroClear, are certain lots where we physically cannot get a result on our platform. It's coming across as either absorbance error or error codes for multiple different assays, things like core total, syphilis, surface antigen. it's kind of across the board. And it's not, it's essentially like we could take. Take one specific lot number and test it on either the Architect or the Alinity platforms, and we are getting the same issues. And so right now we are all kind of scrambling between sites to share the QC that we know does work with our platform. Gotcha. 2:16 - Andrew Hartmann (UTAK Laboratories) And do you have an idea on like what type of volume you'd be looking for? 2:21 - Reid, Lilly A. That is something that we would have to reach out to the sites and get kind of an estimate on like what they're usually like they're ordering. We mainly today we're just seeing if it's even feasible to make what we need. Okay. And then we could get back to you with different volume types later if we decide to, you know, go down this path. Awesome. Yeah. 2:44 - Andrew Hartmann (UTAK Laboratories) So right now we get our real human serum through donor banks that we work with. They're all FDA accredited, but they're currently only testing for hepatitis B, hepatitis C, and HIV. Obviously I heard syphilis. Is there anything else we would need? to add into the testing. 3:01 - Reid, Lilly A. So currently we use our ViraClear for, we do hepatitis A, IgM and IgG, surface antigen, hepatitis B surface antigen, hepatitis B core total and core IgM, as well as HCV and syphilis. Michelle, am I missing anything? No, I think that's everything. 3:28 - Alexander, Michelle F. I thought so, okay. Are you guys capable of doing your own screening? 3:33 - Andrew Hartmann (UTAK Laboratories) Like if we were to send you samples of some of our serum, could you test it, make sure that it's negative for use and let us know? Or would we need to have a third party like certify it for you? No, we should be able to test it ourselves. 3:47 - Alexander, Michelle F. Okay. Yeah, because we have established cutoff ranges of what we would deem negative. 3:52 - Reid, Lilly A. So, right, Michelle? Like that would be the process that we would go down? Yeah. To me, it's very similar to the DOA. 4:00 - Alexander, Michelle F. A sample that we have made, we all get together of all the sites, everyone figures out what their order, how much they would need to last a year or so, and then it would all be one massive PO broken out and shipped to different sites. Perfect. 4:18 - Andrew Hartmann (UTAK Laboratories) So there's really two main product lines I can think of from UTAK that would support you. I'll start with the easy one, which is going to be our lab-created serum. It's a synthetic matrix that we're making in-house. It's combining most of the components of real human serum. It was originally made to be a negative for vitamin and hormone testing, but we have a lot of people in, like, the protanomic space and other spaces that tell us it's a really good blank for their testing, too. Since that one is lab-created, we kind of know right away there's not going to be, you know, anything in there that we'd be looking for, I think, for virology testing. The other option we have would be real human serum. Now, since we're not testing for all of that, we would do what We call it a matrix sample, which is you would tell us how much volume you want, we would create that pool, and then we would send you a sample of it. You would test it, let us know if it passes or fails. If it passes, you give us the thumbs up, we do all the aliquoting, we ship the product off to you. If it fails, you tell us, hey, you know, it's not working, and then we produce a new lot to find out, you know, if we can get one that works for you. And if we're running into issues there, then what we would want to do is just switch to single donor. So rather than starting with the pool, we would send you a bunch of samples of single donors. We would test each one of those donors, let us know which ones are negative, and then we would pool those together to get your volume. Does that kind of make sense? 5:44 - Reid, Lilly A. Yeah, that definitely makes sense, for sure. 5:47 - Andrew Hartmann (UTAK Laboratories) I think we'd have a pretty good shot just going straight to the pool, based off what you're looking for, because all of these donors should be, you know, healthy human donors. So I wouldn't expect them to be positive for these, but I could I say for sure, just since we've never tested it, and it's a little outside of the normal people that we see using this product. 6:06 - Reid, Lilly A. No, and I totally understand, which is why I just wanted to try to get some more information, because I know it's kind of a weird ask, given our situation. But knowing that we need it negative for so many assays, and then, because a part of the issue that we're having right now is that we're getting absorbance errors to where it's like almost undetectable to our analyzers. So we would need at least a smidge of something in there, so it's not 100% zero, but would still fall underneath our negative threshold. Gotcha, yeah. 6:37 - Andrew Hartmann (UTAK Laboratories) I think right away, you know, a step we could take just to get an idea of how our product is going to work for you is, I have little 10 ml sample vials, so I can send you a sample vial of our lab-created serum, if you'd be open to trying that one, as well as a sample vial or two of a couple of our lots of the human serum. Now, this would not be tied to an order, so when you go to place an order, we wouldn't have those same lots necessarily available. But just more conceptual, you know, check it out, see if it's working or not working, and then that might help us steer in if we need to do anything different design-wise. 7:12 - Reid, Lilly A. Yeah, I would definitely push that question or that answer more to, like, the others on the call. They are at our main hospital, which has all of our chemistry technical staff that would ultimately, like, make the decision. So I don't know, Leah, Michelle, if you have opinions on that, or Dr. Sun, what you think. 7:33 - Sun, Qian (Corewell Health) Andrew, do you know, because we're a quite large hospital system and many sites would need this product, for the drug of abuse panel, we normally order enough so that it can last the whole system for, like, a year or even longer. For the poll that you just described, do you think you have enough volume? We wouldn't necessarily, of the initial. 8:00 - Andrew Hartmann (UTAK Laboratories) But whenever you guys, you know, once you tell us the volume, then we would manufacture it just for you. So, you know, if you tell us, you know, hey, I need 20 liters, I need, you know, 100 liters, whatever it might be, we would then at that point go out and source it. And you would also be getting fresh manufacturing, so you would get maximum shelf life. On both of these, it's going to be a two-year shelf life. We can also, you have aliquot options. So, if you want to buy bulk bottles, thaw it, make smaller aliquots yourself, you can do that. If you'd rather have us do the aliquoting, we can also handle that for you. Okay, that sounds good. Yeah, mean, for us, from like a design and a pricing perspective, we need to know, you know, if you want to do the synthetic or the human, we need to know aliquot size. So, like, what size vials or bottles do you want? And then total volume, and from there, I can kind of work up some pricing, but just more, you know, I always believe kind of just getting product in your hands and trying. It Out is one of the best ways just to get an indication, you know, if this is going to work or what direction we need to take. So if you're comfortable with it, if one of the sites would be willing to do some testing, I'd love to send you a couple samples of our real human serum, as well as a sample or two of our lab created and just see how those work for you, and then we can go from there. Yeah, I think that sounds good. 9:24 - Sun, Qian (Corewell Health) Perfect. You can probably send it to Michelle at Loyal Oak. We can test it. Let's see if I have that address empty. 9:36 - Andrew Hartmann (UTAK Laboratories) They just changed my CRM, and I'm trying to learn a whole new computer system. Ugh. It's the Royal Oaks, you said? Yeah. Yeah. Is that the 3601 West 13 Mile Road? Yes, it is. Perfect. And sending it to your attention, Michelle, is the best way to get it? Yes. Perfect. Well, I will get that keyed in. Being a frozen product, we'll ship it out on Monday for delivery on Tuesday. If you could just kind of test them, let me know how they work, if it's perfect, if there's anything that's coming up positive for or any other issues, and then we can kind of go from there and figure out design-wise what we need to do. 10:58 - Sun, Qian (Corewell Health) Thank you. Thank Thank you. Thank you. Thank you. Awesome. Any questions? 11:02 - Andrew Hartmann (UTAK Laboratories) Any concerns? 11:07 - Reid, Lilly A. Just for, like, a quick cost analysis, do you have, like, just, like, a basic – I know because it's custom, but, like, do you have any, like, base pricing, just so we can get an idea of financials to compare to what we're currently spending for bio-red? 11:23 - Andrew Hartmann (UTAK Laboratories) Uh, we're looking at our synthetic serum, uh, our stock product is for 100 mils, 957.70, uh, and then our real human serum stock product, 500 mil bottle is 2,497. Do you happen to know what you're, uh, you're spending on bio-red? When I quote it out, we can try to be as competitive as possible? Uh, we probably have to get back to you on that. 11:52 - Reid, Lilly A. Like, obviously, because we have a bio-red contract, I believe we do get somewhat of a discount. Um, but I know that we have, like, currently our viral – We could get it one of two ways. could either get, like, pre-made analyzer-ready aliquots that come, they're, like, I want to say, oh, Michelle, do you remember the tubes? Are they 3ml vials, I want to say? They're a 5ml bottle. 12:14 - Alexander, Michelle F. We usually get them in, like, a pack would be, like, 10 of them in a single container. Yeah. 12:23 - Reid, Lilly A. Okay, because I was trying to think of, like, the yellow top tubes, if they're, I think they're 5ml tubes, and there's 10 in a sleeve, and I want to say that runs us, like, six-ish hundred bucks or something like that. But I could get more specifics and get back to you and help with that. Awesome. Do you have a ballpark on, like, yearly volume? 12:44 - Andrew Hartmann (UTAK Laboratories) Are we talking, you know, two or three liters? Are we talking 20 liters? 12:50 - Reid, Lilly A. We'll have to, like, reach out to the other sites that are going to need it as well because they're not included in this call. 12:56 - Alexander, Michelle F. were just trying to get the ball rolling first, and then we'll ask them for... How much they would need and how much would need to a year or That's a real problem. 13:06 - Reid, Lilly A. The two, like Royal Oak and Dearborn that are on this call, we would be the two sites that would utilize this the most because we do do full hepatitis testing. So we would be using the most volume and then it would get, we would have some additional volume coming in from the other sites that are running, just only a few of the assays. So they wouldn't use as much. Okay. And do you guys prefer the convenience of it already aliquotted or would you want like bulk and kind of doing that yourself? I would say it would depend on the size of the aliquots and then obviously the financial difference between and the stability of if we did aliquot it ourselves, how long is it good for? I think that's going to have to be a whole conversation in and of itself just to determine like ease of use versus the cost of, you know, just having the staff do it themselves. So yeah, I looked up the ViraClear product and our stability is going to be. 14:00 - Andrew Hartmann (UTAK Laboratories) A different. So our thawed stability is 30 days. Our frozen stability is going to be 24 months if we're making a lot that's fresh for you all. You can do a handful of freeze-thaw cycles, but we don't recommend like multiples. So if you buy like the big bottle, you know, one or two times thawing it out, aliquoting the smaller is A-OK, but we wouldn't want to see you like moving it back and forth, know, freezer everyday, freeze it, thaw it. Got it. Got it. So, yeah, I got you can come up with an ideal fill size as well as total quantity. I can quote you both bulk and aliquot it out so you can see the price difference of having us do that work for you and decide what's better. OK. 14:40 - Reid, Lilly A. Yeah, I think we would definitely have to get our total system volume needed and then kind of determine it from there. Awesome. 14:49 - Andrew Hartmann (UTAK Laboratories) Well, we'll start with those samples. You should get those Tuesday, so I'll connect with Aline after this call and have her process it and then she'll send over an order confirmation. Let me know how the Let's go, and then we can reconnect and dial in design and get you quoted. Okay, cool. I appreciate that. Yeah. Anything else I can do for you while you have us? I don't have anything else unless you guys do. Awesome. Well, I hope you guys aren't getting hit by the polar vortex this weekend. It's going to be like 7 here in Missouri. I'm sure Michigan's not going to be any warmer. Oh, it's already terrible, so. Oh, yeah. I left Southern California where UTAC is located in the winters. I definitely regret it. I can understand that. it's supposed to be 3 on Sunday. Oh, what do you even do? Bake cookies is my answer. I'm going to be baking so many cookies this weekend. inside and question our life choices. Yes, yes. crockpot meals that take forever to cook, and it just warms everything. 15:49 - Alexander, Michelle F. Oh, that's a good idea. 15:50 - Andrew Hartmann (UTAK Laboratories) Use the crockpot to heat the house. 15:52 - Alexander, Michelle F. Yeah, now I'm thinking chili and cookies. 15:54 - Andrew Hartmann (UTAK Laboratories) You guys have given me some ideas. Yeah, it's very much so. Awesome. Well, back the We'll be in touch shortly. Perfect. I appreciate you so much. Thank you. All right. Thank you. Bye.