Activity

Jarek Flanders - November 07 VIEW RECORDING - 16 mins (No highlights): https://fathom.video/share/FxY26xAiTMAE-3WAACG86zAY9pDoM-g8 --- 0:08 - Andrew Hartmann (UTAK Laboratories) Hey, Megan. Hello. Hey, Jarek, how are you? Good. How are you, Ben? Doing great. It's pumpkin spice season treating you well? It's good. 0:35 - Jarek Flanders (seroclinixlabs.com) Yeah, there's always pumpkin in upstate New York. Yeah, this whole state is just apple trees. So, you know, you got cider around every corner. 0:42 - Andrew Hartmann (UTAK Laboratories) I was going to say, I'm more of a cider man than a pumpkin spice guy. So that's right up my alley. Yeah, they both work. Yeah. 0:48 - Jarek Flanders (seroclinixlabs.com) The markets die down once people are sick of buying pumpkins. So that's fine. About the time to pass. 0:55 - Andrew Hartmann (UTAK Laboratories) Well, appreciate you hopping on with us. Just some quick introductions. We have We Maryssa and Megan from our product design team, so they're kind of the brains behind our operation, and they'll be the ones to help us create the design behind the scenes. Okay, yes, perfect. Awesome. So, I don't, yeah, anything, sorry, I cut you off. Oh, go ahead, no, if you have something, go ahead. 1:17 - Jarek Flanders (seroclinixlabs.com) No, I was just going to say, I know I brought up Billy Rubin last year, but the main reason, sorry, my dog was shaking right there. The main reason we were reaching out today, because we want to consolidate how many CALS controls we're using right now. And see if someone through tech, like looking through all your products through the years, that you can get a lot of analytes in one, in one matrix. Are you currently making anything like this in-house, or are you using third parties? yes, a few different other manufacturers, and one or two products in-house as well, overall. For the product you're looking to have us make with all nine analytes, have you made that yourself in-house? Not all of them in-house, no, we have contracts with other manufacturers for OEM. 5 7 9 9 10 So we wanted to reach out to UTAK, to you guys today to see if really you have solutions to get better KELs and controls and linearity for us to try and bring it as much as you can into one sample, really. 2:18 - Andrew Hartmann (UTAK Laboratories) So what we can start with is just kind of getting the basic product design, and then I'll probably turn you over to our team here to help kind of walk through the analytics and make sure we have all those specific questions. So I know when we talked in the past, we wanted to look at both real human urine and our SMX urine the lab created. Is that still the case? Yeah, I feel like synthetic would be easier. 2:41 - Jarek Flanders (seroclinixlabs.com) I did flip through your SDSs and your inserts, and I mean, it's proprietary, but it didn't really say what it made up of to just be sure that it doesn't have anything in this panel. Yeah, the current design that we use for SMX does have. 2:59 - Andrew Hartmann (UTAK Laboratories) we've open got הח mgd! stacă거�rux.еп think it was glucose and was it creatinine? Correct. 3:05 - Meryssa Valdivia-Lopez So it currently does have those in it. 3:08 - Andrew Hartmann (UTAK Laboratories) So one option is to do a baseline and kind of figure out where it's at because we've never tested these before for those. Another option is to look at if we could potentially manufacture it without those components. 3:20 - Jarek Flanders (seroclinixlabs.com) When you say we establish a baseline, would you have that lot in use for a long time? No. 3:25 - Andrew Hartmann (UTAK Laboratories) So with this product, whether we go with the SMX or the real human urine, we're going to want to start with a baseline. So before we do any manufacturing, we're going to want to send you what we're planning to use as the starting matrix. Have you run that, let us know where it's at, and then we'll go from there to go forward to the manufacturing. Does that make sense? 3:46 - Jarek Flanders (seroclinixlabs.com) Yeah, we have two different instrument types that we can try it on, at least. Okay. So we have our own, for those 12 tests, we have our own essays on the market right now. So we have about 20 sites, 20, 25 sites per year now. No. Thank So these are all quantitative. So that's just where we're coming from. Gotcha. Because you guys are selling this, right? You're not using this Yes, we're selling this and providing support, too, for the sites to do all their setup and to get all the parameters from us. So we have our own parameters for four benchtop chemistry analyzers right now. And this is mainly for urologists at the moment. Okay. And I think? Okay. They are LDTs right now, which is why we want to reach out. If your stuff looks good, then we work for OEM and taking the rest of it to FDA approval. Because not much is, a lot of this isn't FDA approved yet on this panel for quantitative urinalysis. Yeah, we haven't started doing it, but we are cracking open the door to white labeling. 4:48 - Andrew Hartmann (UTAK Laboratories) So that might be potentially something you can explore. that's what we do. 4:51 - Jarek Flanders (seroclinixlabs.com) We have a couple large manufacturers that do make some of this stuff. And they either unlabel or label for us. And we have our own catalog. 4:59 - Andrew Hartmann (UTAK Laboratories) We have our own 5:00 - Jarek Flanders (seroclinixlabs.com) We for our own branches of customers, down straight through that. Do you mind sharing with us who your other OEM partners are? 5:07 - Andrew Hartmann (UTAK Laboratories) No, thank you. 5:09 - Jarek Flanders (seroclinixlabs.com) No problem. But we have this 12 panel on the market right now, though. Okay. 5:17 - Andrew Hartmann (UTAK Laboratories) But it's not all nine of them in one product right now? No, it's not all nine in one product, yeah. 5:24 - Jarek Flanders (seroclinixlabs.com) It's only the basic ones are grouped into single controls like creatinine and pH-spiff of gravity. That's what's been around forever. So those are of packaged together, basic ones on the market. But each other assay has its own cal, its own control. So that's where things kind of really build up in our catalog. And also, it's more for the sites, too. Not only have to purchase, but keep track of. So if we can get approval not only on our sites, the LDTs are fine because we do their process for them. But if we can get to the market for FDA, then we want the least amount of items possible. Hey, this item right here covers this whole list for everything, rather than each test has its own catalog for calibrators and controls. So, like I said, consolidating things down. Gotcha. Less regulatory. But because that's a lot and all these sites have been testing large volumes, a linearity set would be a good starting point for us for as many analytes as you can fit into one sample. And then if some don't work, if some do, then that's great, hopefully as many as you can. I think some would be easier than others, but again, that's up on your end. Gotcha. Does that kind of cross off the basic stuff you're looking for? I think a good amount of the information, yeah, for physical design. 6:48 - Andrew Hartmann (UTAK Laboratories) I think I saw a one mil fill size. Is that what you would be looking for for the model? 6:51 - Jarek Flanders (seroclinixlabs.com) Yeah, yeah, let me just get one more spot, because we don't need really that much thought stability for these. So, by. About a milliliter for linearity frozen. As long as it's stable for up to two days, then that's fine with us. If the frozen temp is at least, I don't know, six months to a year plus. I don't think we have stability. 7:17 - Andrew Hartmann (UTAK Laboratories) We're not going to have stability data on these analytes. So we're not going to be able to make a guarantee, you know, up front. We're going to be quoting everything as like NA, which means essentially like we're going to spike it in. We're going to use, you know, our process, our weights and measures, all of that kind of stuff. But we're not going to tell you what we expect you to recover. no, no. We're going to test it as we go. Okay. the ability to keep it internal. 7:41 - Jarek Flanders (seroclinixlabs.com) We just want to say we'll keep you up to date on how that looks on our end. If I save this in our lab for six months and it looks great, then we'll follow up and say, yeah, this looks good. So we know how much – that really dictates on how much we keep on hand then. And if we are doing this as – 8:00 - Andrew Hartmann (UTAK Laboratories) Linearity set, and we're going to be sending this out to your customers. Do you have a ballpark idea of, like, how many of these sets you might run through in a year? In a year? I have rough month numbers, so yeah. 8:14 - Jarek Flanders (seroclinixlabs.com) Linearity, I need 10 a month of one milliliter. And then if these linearities look good and we can transition, because they are testing right now, so we would have to do these validations side-by-side for that test. If we were to get into calibrators, then in controls, we need 40 a month for calibrators and 80 a month for controls. Calibrators, 2 mils. Controls, somewhere between 5 and 10 mils. 8:50 - Andrew Hartmann (UTAK Laboratories) Are you looking for us to quote all three of these products right now, or do you want to just start with linearity? Just linearity, rather than pile on a bunch of information, a bunch of work, and that's... 9:00 - Jarek Flanders (seroclinixlabs.com) And, I mean, I've seen your stuff on the market, so I'm confident that we can at least get, I would hope, at least eight or so, which could save a lot. So I think if the linearity stuff looks good, then we can work with the quoting for the other two, Kales and Controls. 9:17 - Andrew Hartmann (UTAK Laboratories) So we'll do a one mil fill size. Your usage is approximately 10 vials a month. So what we'll do is we'll quote you at our minimum order size for just kind of like trial order. That would be 50 ml, so it would be a total of, what, five, or sorry, 50 of the kits. So it would be about a five-month supply for you. Okay, 50 ml is your minimum? Yes. Okay, that's good to know. And then I'll probably also have you quoted at like a one-year order volume just to kind of show you what our tiered pricing is, because the more that you can order in one order, the better of a per-bile price you're going to get. Yeah, exactly. And then, yeah, and then you can just make it all in bulk. 9:54 - Jarek Flanders (seroclinixlabs.com) That's what our own stability studies will tell us, too. So six months to a year. A from now, we'll know, all right, well, you know, instead of getting 10 a month, we'll just do 60, since we know this ability. 10:07 - Andrew Hartmann (UTAK Laboratories) Exactly. That dramatically can improve pricing. Yes, yes, yes. Make it all at once, and then we'll all, you know, less shipping, less everything. 10:15 - Jarek Flanders (seroclinixlabs.com) One and done, yeah. 10:18 - Andrew Hartmann (UTAK Laboratories) On the note of pricing, do you have, like, an expected budget or a target you're trying to reach for this material? 10:25 - Jarek Flanders (seroclinixlabs.com) Not sure. I know the, I'm looking at the quotes from last year for the combined, the, quote, 4, 4, 5, 1. And that was just under four grand for that minimum. If we can get at least eight of those analytes in there for five grand, I feel like that'd be, that'd be a good ballpark number for us to start at. Gotcha. 10:51 - Andrew Hartmann (UTAK Laboratories) Yeah. Perfect. And then when it comes to the specific analytes, So this might be where, if you could kind of jump in to clarify what our questions were with these. Yes. 11:07 - Meryssa Valdivia-Lopez So most of these we are familiar with. We just wanted to verify the microalbumin, microprotein, and nitrate. 11:19 - Jarek Flanders (seroclinixlabs.com) Okay. Yeah. The microprotein was actually, what I was going to bring up now, is digging through our inserts for assays. It's actually the same analyte. They're both albumin. Okay. microprotein is albumin. So we would have to rule out the microalbumin because of that. It's the same assay, just more sensitive. Okay. So it's putting the same product in twice. So we'd actually have to eliminate the microalbumin. That was actually the first thing I meant to bring up on this side. 11:48 - Andrew Hartmann (UTAK Laboratories) So we're going to do eight, not nine drugs. Is that right? Yeah. Unless you can get leukocyte esterase. 11:54 - Jarek Flanders (seroclinixlabs.com) I've seen a lot of standards on the market. I don't really know how far people have gone into that. That would be a question for you, for your team. Okay, yes, that's definitely something we can look into. Yeah, that's not quite as your simple search and you get something or something. It's been out a long time ago. Yeah, that's where I see things getting a little more difficult. That's why thinking right in between microalbumin and leukocyte could probably be the minimum. Okay. I know you had a question with nitrate too, so that will leave us with eight analytes. 12:36 - Meryssa Valdivia-Lopez Yes, we just wanted to know if you have what you're specifically looking for for the high sensitivity nitrate. That's normal nitrate. 12:47 - Jarek Flanders (seroclinixlabs.com) Okay. It's just, it's lower levels than, say, toxicology. Because now you're going from tox as an adulterant into your analysis. ACTION ITEM: Email Meryssa nitrate CAS + SDS for low-level nitrate - WATCH: https://fathom.video/share/FxY26xAiTMAE-3WAACG86zAY9pDoM-g8?timestamp=773.9999 from tox as adulterant your analysis. Yes, So you need to talk to a lot lower levels. 13:04 - Meryssa Valdivia-Lopez Do you happen to have the CAS number for that? I do not. 13:13 - Jarek Flanders (seroclinixlabs.com) Actually, let see if I can find an SDS. Can email you back with that? You said CAS number for nitrate, right? Yes. Okay. I may not have it immediate, so I want to search and wait. It is just standard nitrate, though, that you would normally find in a urine sample. It's just lower levels. A lot of adult transfer toxicology use a lot higher levels. 13:52 - Meryssa Valdivia-Lopez That's why this is just lower. 13:54 - Jarek Flanders (seroclinixlabs.com) So it's not like a different compound or something like that. Okay. Okay. Perfect. 14:02 - Andrew Hartmann (UTAK Laboratories) Did you have any other clarifying questions, Maryssa? 14:07 - Meryssa Valdivia-Lopez I think that's it. All right. So we're going to quote two options. 14:13 - Andrew Hartmann (UTAK Laboratories) One option in human urine, one option in our SMX urine. We're going to do a one-mil fill size. We'll quote you minimum order volume as well as a one-year estimated order volume just to kind of show what pricing is going to look like. ACTION ITEM: Investigate leukocyte esterase feasibility; update Jarek - WATCH: https://fathom.video/share/FxY26xAiTMAE-3WAACG86zAY9pDoM-g8?timestamp=863.9999 We've got eight analytes for sure that we're going to be targeting, so we're removing the microalbumin, which is just going to be the same thing as the microprotein. And then our team will also look into seeing if we can get this leukocyte esterase, if I pronounce that right? Yes. And we can, we'll look at adding that in as well. Yeah. 14:44 - Jarek Flanders (seroclinixlabs.com) One route is the eight, and the other route is the nine-analyte, which would be L-8 leukocyte esterase. Gotcha. Correct. 14:52 - Andrew Hartmann (UTAK Laboratories) Kind of a bonus to add this one in. That's the one with the asterisk, yeah. 15:00 - Jarek Flanders (seroclinixlabs.com) Got it. And budget, we're targeting under 5K. 15:05 - Andrew Hartmann (UTAK Laboratories) You know about the baseline sample, so we'll be able to send it to you, have you guys run it. 15:09 - Jarek Flanders (seroclinixlabs.com) we'll get it on two different instruments, the synthetic and the donor. ACTION ITEM: Send Jarek quote review link; then send 2 quotes (human/SMX, 1 mL, 8 analytes, 50 mL + 1-yr) - WATCH: https://fathom.video/share/FxY26xAiTMAE-3WAACG86zAY9pDoM-g8?timestamp=914.9999 15:14 - Andrew Hartmann (UTAK Laboratories) Awesome. I think that's it for my questions. Anybody here have any other questions or anything else to go over? No, I think we're good. 15:24 - Meryssa Valdivia-Lopez Awesome, Jarek. 15:25 - Andrew Hartmann (UTAK Laboratories) Well, give us a couple of days to get all of this worked up, and then I will send you out a link. So we can reconnect, and we'll just kind of go over the quotes real quick together and see if there's any questions, decide if we want to make changes. Yep. 15:37 - Jarek Flanders (seroclinixlabs.com) Just any questions, ask me, and then when you want to send the stock blanks, we'll do our baseline. Perfect. 15:46 - Andrew Hartmann (UTAK Laboratories) Awesome. Well, thank you so much. We'll be in touch soon. All right. Take care. Have good one. You too. Bye. Bye. Bye.