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Fathom had issues and only recorded a part of the call, overall whell received and looks like it may move forward. Jarek Flanders - November 18 VIEW RECORDING - 13 mins (No highlights): https://fathom.video/share/R4X6go4TiVWp8psr1cwMMkLyKTFxM_go --- 0:00 - Andrew Hartmann (UTAK Laboratories) Essentially, you know, we believe in frozen form, the product will be fine for 18 months, but once thawed, we just can't guarantee stability of those analytes, whether it will be, you know, one second, one day, one month, one year, we just don't have. 0:12 - Jarek Flanders (seroclinixlabs.com) If the starting with linearity looks good, this will be a one and done. They use it, then it's done. There won't be something to hang on to. So we would hope that would definitely help with the stability. If they're just thawing and using within 24, 48 hours, I would think that's fine. Perfect. I would think. 0:32 - Andrew Hartmann (UTAK Laboratories) then delivery time. So once you place the order, approximately 10 business days, and we're going to get that baseline sample out to you, you're going to test that. Once you get us those results back, it's around 35 business days for us to make the product. And that lead time is just a little bit longer than our normal one because of that analyte and the timeframe to get that. Yeah, that LE. And I know we were kind of targeting a price point of five grand for the whole order. Obviously, you could see. See, we were unable to hit that, so just kind of wanted to be... Yeah, it's a big panel, yeah. 1:05 - Jarek Flanders (seroclinixlabs.com) But then, yeah, once you jump up to the 5, though, I mean, it's 16, 800. 1:11 - Andrew Hartmann (UTAK Laboratories) Much more reasonable, and you'll see a change in this when we go to the SMX quote, too, and I'll kind of explain that when we get there. Okay. It's like Howard is coming back in. Okay. Any questions on the real urine quote before we move on to the SMX? No, no. 1:30 - Jarek Flanders (seroclinixlabs.com) Well, I'm guessing for creatinine, you would just substitute what we got for the baseline and then spike from there? Not necessarily. 1:39 - Andrew Hartmann (UTAK Laboratories) So, usually, like, let's say, you know, your lowest target is 10. Let's say your baseline comes in at 20. You know, our team is going to use DI water to dilute down in order to hit that target concentration. Okay. Okay. We do this all the time with, like, metals controls, hormones controls, all of those kinds of things where there's, like, a certain starting level, and we're trying to hit certain targets. let's say... Let's It's well within our wheelhouse. Yeah, something's going to get picked up, not a true zero. 2:05 - Jarek Flanders (seroclinixlabs.com) Mm-hmm. 2:07 - Andrew Hartmann (UTAK Laboratories) And then moving on to our SMX quote. So this one is going to be the one in SMX urine. Very similar formatting. So here's your part numbers, same packaging configuration, same order volumes were quoted. And then we have your pricing breakdown. Now you'll notice the SMX urine is a little bit more. It's just the cost of the materials of making that SMX urine. But where you'll really see that coming into play is in this volume discount. So in the other situation, it almost cut the price in half for a little bit more. And here it's not making as much of a difference. And that's just because on our end, the SMX matrix is so much more expensive than the real human urine. So like that incremental cost is just much higher for the additional levels. Same analytes, same concentrations, all of that. The difference that we would want to make here is if you guys are interested in using our SMX serum, we already know. That we're putting in, let me see here, it is albumin and creatine we put into our normal one. We can control that on the back end, but before we would move forward making this product, we would just want to send you a sample of our stock SMX urine, have you run it, and just confirm it's negative for everything else on this panel. The reason being is, you know, some of the analytes we buy are like 99% pure, but we're not able to, you know, say what that extra like 1% is or 0.01% is. So we would just kind of want you guys to do a double check on our matrices just to make sure that, you know, some of that supplier contamination isn't what you guys are actually looking for. 3:40 - Jarek Flanders (seroclinixlabs.com) Yep, sounds fair. Do it so early in the process. 3:43 - Andrew Hartmann (UTAK Laboratories) Yeah, and once we validate, if you do the SMX, you know, the first time around that, hey, this lot works for you, you guys would never need to do another test. Every time you order it, we would just be able to, you know, do the math, weights, and measures, and make it out. Okay, so if it was real urine, we'd probably do the baseline per order? 3:58 - Jarek Flanders (seroclinixlabs.com) Exactly. 3:59 - Andrew Hartmann (UTAK Laboratories) Yeah, real urine. Baseline, every order, SMX, urine, basically validate that, hey, it's not in it, and then we don't have to worry about it. Okay. And then same lead times, 10 business days after receipt of order to get that matrix sample, 35 business days to receive that final product. There is a note here, you'll see this order, since it goes up over $25,000, does trigger our deposit requirement. So if you were to place this order, 20% deposit would be needed prior to us beginning the manufacturing process. Okay. 4:32 - Jarek Flanders (seroclinixlabs.com) Any kind of questions? 4:34 - Andrew Hartmann (UTAK Laboratories) What's your thoughts? 4:36 - Jarek Flanders (seroclinixlabs.com) Do you know, typically, for this custom, do you provide SDS, COA? Any answers of that? Yeah, we could do that. 4:46 - Andrew Hartmann (UTAK Laboratories) Typically, IFU is all we provide initially. If requested, we can provide a COA. That's not a problem at all. And then SDS sheet, also not a problem at all. Okay, yeah. You just added. Last time you'd mentioned you. 5:00 - Jarek Flanders (seroclinixlabs.com) UTAK's getting into the white label as well? Yeah, we're starting to look into it. 5:05 - Andrew Hartmann (UTAK Laboratories) We have yet to actually move forward. We're still kind of looking for a partner that can help us walk through that process. So it sounds like it's something you guys have done before. And, you know, if you're interested, I would love to kind of connect on a meeting with our regulatory team just to investigate. Like, you know, we just have some questions as far as like symbology and, you know, how you guys have seen other vendors do it just to make sure we're in alignment with that. Yeah. 5:29 - Jarek Flanders (seroclinixlabs.com) Right now we're in the middle of, you know, LDT approval and hopefully long-term 510K cleared. So we're kind of in this gray zone almost. But we do have OEM partners that do label and do COAs for us, and we have some that do not. So, like I said in the initial, we're really trying to cut down on how many items we have in total. That's why we asked for this large panel of nine analytes. 5:54 - Andrew Hartmann (UTAK Laboratories) Yeah, I mean, I would think at least for like the initial, hey, let's find out if it works or not. Let's just stick with our packaging just for. Yeah, sounds fair. But if everything is working and looking good, you know, I think we bump it up and kind of look into ordering packaging. Okay. 6:08 - Jarek Flanders (seroclinixlabs.com) Yeah, we have pretty much our own line from Rage and Cal Control down. So, like I said, some people we have partners with to work with us on that, like expanding into it now. Howard, anything on that, on the regulatory side? No, think you covered that, Jarek. 6:29 - HL (seroclinixlabs.com) know, like that's exactly what we currently do, so that's perfect. Yep, we're all good. Okay. Yep, all good. 6:36 - Jarek Flanders (seroclinixlabs.com) Perfect. 6:36 - Andrew Hartmann (UTAK Laboratories) Price point-wise, what are you guys thinking? Is this kind of in the ballpark of where you'd expected or...? 6:46 - HL (seroclinixlabs.com) What's the per mil cost of having all nine? Do have a rough breakdown of the per mil cost? 6:56 - Jarek Flanders (seroclinixlabs.com) Yeah, can we go back to the real Yearn? Because that's... What is the thing? What do design Okay, We're We It seems to be. I know we don't have to do the baseline every time, but, I mean, that seems pretty pricey. 7:10 - Andrew Hartmann (UTAK Laboratories) So at our minimum order size, you're looking at about $77 per mil. Okay. Okay. 7:18 - HL (seroclinixlabs.com) And that would include nine nanolites, and we'd need, what, three levels, Jarek, and then two QC levels? Oh, they're all five. 7:25 - Jarek Flanders (seroclinixlabs.com) They're all five levels. We'll start with linearity. Oh, I see. I see. 7:30 - HL (seroclinixlabs.com) Okay. Okay. Start with linearity. Okay. Got it. 7:32 - Jarek Flanders (seroclinixlabs.com) Got Start with linearity, and if this looks good, because we need at least some sort of stability to know for the analytes, then we can move on to the calism controls. But we've, yeah, so I sent them a breakdown of what we want to start with linearity, which are all the concentrations he's showing there. Yeah. then I sent them calibrators and controls to possibly open that channel if these linearities look good, because then again, we can... Cut a lot of the stuff down, and cut down nine into one vial. mean, could, you know, the item catalog is quite large. 8:12 - HL (seroclinixlabs.com) Yeah, yeah. At this higher volume, you're looking at about $32 per mil. 8:16 - Andrew Hartmann (UTAK Laboratories) So, you know, significant if the product works. And then again, like if volume even goes over this, you can probably expect to see this going down, you know, even further. Okay. So what's that? 8:26 - Jarek Flanders (seroclinixlabs.com) 25 times 5, so 125 mils. Am I reading that right? Yes. 8:32 - Andrew Hartmann (UTAK Laboratories) Okay, 125 mils. 8:33 - Jarek Flanders (seroclinixlabs.com) Okay. 8:35 - HL (seroclinixlabs.com) And then the other three N-lights, is there a mixing or stability issue when you add the other three? 8:43 - Jarek Flanders (seroclinixlabs.com) Well, I didn't venture into pH and specific gravity because I don't really know how they'd alter that. We would not want to do that in the same control. 8:53 - Andrew Hartmann (UTAK Laboratories) Yeah. When you start messing with those, it starts messing with the, I think it's the creatinine or the nitrate. I just know that they all don't play nice together. Yeah. 9:00 - Jarek Flanders (seroclinixlabs.com) Yeah, pH and specific gravity, because now you're going to get high linearity and a higher low pH or something. And then microalbumin, per the FDA insert for microalbumin and microprotein, they're both set to calibrate albumin. Oh, got it, got it. 9:23 - HL (seroclinixlabs.com) Okay, so you don't want to admit it. 9:23 - Jarek Flanders (seroclinixlabs.com) But because I believe we went over the multicale thing, where we can kind of disregard microalbumin, so we'd cut down to this one, a pH, and a specific gravity linearity, if this were to work out. So three items. 9:40 - Andrew Hartmann (UTAK Laboratories) We can also look into making like a pH-specific gravity control, if you'd be interested in, you know, another panel that just covers those. Okay. 9:52 - Jarek Flanders (seroclinixlabs.com) The more routine, it's just like you covered it right there, saying once you start messing with those, who knows how everything else is going to react. Okay. next Yeah, pH doesn't play nice with a lot of analytes we find. 10:04 - Andrew Hartmann (UTAK Laboratories) No, no, no. I'll go ahead and send these over to you, but any other questions, any other information you'd like along with it, or just one little time to look them over? 10:18 - Jarek Flanders (seroclinixlabs.com) Yeah, I think Howard and I will give it a look over. I think we're kind of on the same page for a regulatory standpoint, where if we like it, we would like to OEM your product. And, of course, we would do our own testing because yours is more of a, here's the stock, tell us what you think, type of playground. Yeah, we don't have. I think that sounds good. 10:45 - Andrew Hartmann (UTAK Laboratories) Yeah, exactly. 10:46 - Jarek Flanders (seroclinixlabs.com) And then when we start seeing our customers, you know, test linearity out, we'll know that if you're using the same process that we can, we feel good about the long term. Like I said, if the linearity looks good and we are fine with how stable. enabled is that we could transition to using calibrators and controls as well, to really, like I said, cut down that item catalog. Perfect. But I like that everyone got together and figured the 9-Analyte seems pretty realistic, that panel. You have the uropal nitrogen and the bilirubin more so, but it looks like it's an amber, so those shouldn't be damaged too much. 11:31 - Andrew Hartmann (UTAK Laboratories) And, you know, if you guys do have, like, a specific biotype you want to switch to or anything like that, you can let us know. We can always accommodate that as well, if there's something that looks better for, you know, your labeling or your customers. 11:42 - Jarek Flanders (seroclinixlabs.com) Yeah, I think linearity would be a mil, because they're going to thaw it, use it, toss it for the day. If to go down calibrators, it's probably more like 5 to 10 mil per, and then they would use it for a week or so. So, but that's down the line. I do really want to see. I these look, though, this nine animalite panel. But I'm glad you and your team were able to pull something together to say, hey, we feel confident in this nine. And that you looked into Ellie, too. We talked about how, like, when I searched the market, I couldn't really find too much, but I know it's out there. But you seem to have sourced a vendor that you may feel comfortable with. 12:20 - Andrew Hartmann (UTAK Laboratories) Yeah, we have professional drug buyers. Okay, there we go. A couple federal permits for that, yeah. Qualify vendors all day, and check COAs, and import process, and all that jazz. Yeah, yeah. That's the fun stuff, yeah. 12:35 - Jarek Flanders (seroclinixlabs.com) Yeah, scheduling, planning, product analysis, yeah. That's one area big and regulatory I don't miss, having to fill out all those DEA forms and all that jazz. 12:47 - Andrew Hartmann (UTAK Laboratories) But I don't think any these are controlled. I think these are all pretty simple to get in. These are all safe, yeah, yeah. 12:52 - Jarek Flanders (seroclinixlabs.com) We've used your tax controls in the past. They're reliable, so that's really why I reached out to you again. again. Hey, See Awesome. 13:01 - Andrew Hartmann (UTAK Laboratories) Well, I will go ahead and get these over to you, and then if you can just kind of let me know when you guys make a decision one way or the other, and we'll go from there. Okay. 13:09 - Jarek Flanders (seroclinixlabs.com) Yeah, we'll go over it, and we'll follow up with you. Awesome. Well, thank you so much for your time this morning. 13:15 - Andrew Hartmann (UTAK Laboratories) All right. Thank you. Bye-bye. Thanks, guys. Bye. See you.