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Gina McLane - October 24 VIEW RECORDING - 22 mins (No highlights): https://fathom.video/share/r-PMos_zXxf1wj4BzJqmt7Mmx-zAiijz --- 0:00 - Cassella-Mclane, Gina I'm doing, I can. 0:01 - Raleigh Gallina (UTAK Laboratories) Happy Friday. Happy Friday. 0:03 - Cassella-Mclane, Gina Sorry, my camera doesn't work. They replaced my screen on my laptop, and when they did so, camera doesn't work. Hey, you know what? 0:12 - Raleigh Gallina (UTAK Laboratories) If I could get your IT, because honestly, it makes it a lot more relaxed if we have our cameras off, too. So don't think that I'm staring at you, but I'll go ahead and keep mine on here, too. Hey, Nicole, thanks for joining us. Hi, how are you guys? 0:28 - Nicole Miller Good, good. It's Friday, so we can't complain, right? Yeah, very true. Awesome. 0:37 - Raleigh Gallina (UTAK Laboratories) Hey, Gina, well, thanks so much for booking a call. I know we had a few threads hanging out there, so I just figured that it would be easiest to get, you know, our Director of Engineering, yourself, myself, on a call so that we can kind of solution through. But before we get there, let's do a round of introductions, so my name is Raleigh, I've been at ETAC for five years. But I'm a bit newer in SEAT in terms of customer care, and I'll turn it over to Nicole. I'm Nicole Miller. 1:06 - Nicole Miller I'm the Director of Engineering. So I've been here for about 10 years now and oversee product design and also quality assurance. So you're in good hands with Nicole here. Awesome. 1:24 - Cassella-Mclane, Gina Okay, cool. 1:24 - Raleigh Gallina (UTAK Laboratories) So I do have a few threads, and so I suppose we'll go ahead and we'll start with the communication. And actually, thank you for your point of education, too, because you've communicated, you know, hey, that when you make cows and QCN house, you use charcoal strip serum matrix or hormone strip serum matrix so that you're not receiving some of, you know, these endocrines in the blanks as well, too. Would you be able to share just a little bit more about... ... That process, and then also your expectations for product from us. 2:04 - Cassella-Mclane, Gina So we order our hormone stripped serum or our charcoal stripped serum, either from Millipore. I think Millipore is the main supplier for both of them. And I'm not sure what their process is to remove them, but when we get them in, they are completely blank or at least well below any kind of limited detection for our endocrines. That is very important because endocrines are going to be different than any other kind of QC that you prepare because you're typically looking at nanograms per deciliter as opposed to nanograms per milliliter. So you probably won't be able to do that with volunteer donor samples and doing a pool of it because everyone's going to have some kind of testosterone or some kind of 17. mean, Hydroxy, Progesterone, Androstenedione, those aren't things that like, you know, urine for drugs of abuse, you can hopefully find a population that's not using any kind of drug, but the other things that are endogenous, there has to be a process to strip them. And that's why when you were sending me the blunt, what you were calling your blank matrix, they all had levels above our lowest QC point that we would be using. So, not helpful for us. They have to be stripped below the level that you're going to spike them at. 3:41 - Raleigh Gallina (UTAK Laboratories) Nicole, I know this is more delving into your realm of expertise. Did you have any thoughts on, you know, kind of what we're able to offer against what Gina and her team need? 3:53 - Nicole Miller So, we don't work with charcoal stripped or any stripped human matrix. We're working with 100% real human matrices. So, Well, That's why I think that did get lost somewhere between us quoting and then the expectation, obviously, of what's coming. So usually how we work with these is we have two options. So we do select a demographic that, like, would be the lowest level of testosterone because I think that testosterone has been the issue for the samples you've gone. You're never going to find that for our population, though. 4:22 - Cassella-Mclane, Gina So, yeah, I mean, yeah, so we're trying to get the lowest, but with being absolutely zero, agreed, it's not going to happen. 4:30 - Nicole Miller So usually what, like, we do make a product like this for a lot of other customers, and one option is to work with a human matrix, and then we dilute with water. So we have whatever the concentrations that it has in endogenous levels. You tell us what those levels are. We dilute with water to achieve what that concentration is. Some customers don't want to dilute. Some customers are fine with diluting. It's really up to you. So the other path that we offer, sorry, go ahead. 4:55 - Cassella-Mclane, Gina The problem with dilutions is if you have done... And suppression studies and mixing studies based on real serum matrices. These dilutions no longer have the same chemistries and attributes of a real serum matrix. So that's, I'd have to run that by my director to see if we could even do that. So that's totally fine too. 5:23 - Nicole Miller Like I said, plenty of customers don't want to be diluting either. So the other option that we work with is synthetic serum. So we have our lab-created synthetic serum that we would expect to be at zero for all levels of the amylates that are in this control that we would just be spiking on top of then. So the downside is that it's not a human matrix, but the pro is that it would be zero for all of the endogenous levels that we would expect. 5:47 - Cassella-Mclane, Gina We can probably work with the synthetic serum as long as I validate it against, I'll have to make in-house QC again and validate it against our in-house. Okay. Have you tested our synthetic serum before? 6:02 - Nicole Miller No, I haven't. 6:04 - Cassella-Mclane, Gina Right now, what we've been using for bringing this assay up is I bought stripped serum and made my own, but also Waters has a MassTrack kit that is glypholized that we reconstitute. So that would be a synthetic, and we're, you know, using that kind of as a backup right now. We don't like the MassTrack one because it has it at all varied concentrations that don't necessarily align with our clinical ranges that we need. Got it. That's why we decided not to stay with them for the QC. But we also don't want to be in a situation where we're making both the CALs and the QC in-house ourselves. We'd like to have a second vendor to verify our CAL vibrators. Yeah, definitely makes sense. 6:59 - Nicole Miller I was just looking. I do know that we have had a stock product that has some of these analytes in it in synthetic serum. Pretty sure that we have discontinued those ones, but we might have a couple on hand. So I think we have a couple options. So one option is just to send you a sample of our synthetic serum. We have 10 mil samples that we could send. If we do have any of those other spiked ones that have at least a couple of those analytes, would you be interested in testing a sample of those? That would be fantastic. 7:28 - Cassella-Mclane, Gina Okay, so we'll look and see if we have anything that's left here. 7:32 - Nicole Miller But worst case, just synthetic serum. 7:34 - Cassella-Mclane, Gina should be able to send you a sample of that one, too. 7:37 - Nicole Miller Okay, perfect. 7:38 - Cassella-Mclane, Gina Now, if we went with the synthetic serums, would they come in frozen or litholized? It's your preference. 7:46 - Nicole Miller Usually with synthetic matrices, we usually gear more towards frozen. But synthetic serum, we have freeze-dried before. So if you are interested in that, we could quote it that way as well. Okay. So, if you're interested in the sample of we have. in of these, so sample that You All right, so I have it noted, Raleigh, as a quote for frozen synthetic for this product, and then also sending an SMX serum sample, and we'll look for the steroids control as well. Awesome. 8:17 - Raleigh Gallina (UTAK Laboratories) Great. Beautiful. Beautiful. So I know, Gina, as well, you were, you'd sent over, or sent back, rather, quotes, 3182 and then 3181. So let me actually go ahead and pull these up so that Nicole also knows what we're speaking to here. And are you able to see my screen? Yes, I am. Beautiful. 8:46 - Cassella-Mclane, Gina Beautiful. right. 8:47 - Raleigh Gallina (UTAK Laboratories) Okay. So we're looking here at 3182. So it looks like the quote issue date, this is from 2023. This is indeed you there too. So we have our product, product description, and then price per pack, extended price over here as well, frozen, unverified. And then I'm going to navigate to quote 3,181 over here, also quoted in 2023. We do have then product, product description, and then we also have our price per pack and our extended price here as well too. So, you know, Gina, can you walk us through just kind of, you know, your pain points, budget-wise, what you're looking for too, and just kind of be able to reframe so that we can bring Nicole into the loop here too? Sure. 9:45 - Cassella-Mclane, Gina So, the current ones that you just discussed are our 20-drug panel that we are currently running, which is more of an ED-geared panel that gets reported out as a POSNAG. So, so, We went with just a high and a low QC, and then we have the two hydrolysis quality controls to make sure our hydrolysis process is working. The new one that I had sent out to get quoted that came back with the astronomically high number that was definitely not going to fit in our budget is for a pain management one that we do need to be more on a quantitative level. It has 60 drugs instead of 20 drugs, and we were trying to do it at three levels instead of two levels, and in some cases, and just like the current one you have, in the lower QC, some of the drugs are at a lower level. We are even fine with getting one QC from you, which I had you re-quote, and we... Dilute it down into two other QCs ourselves when we actually set it up for the run, which was fine with us, just to keep the cost down. When we got the initial quote for the $175,000, that's almost the price of a LC MassSpec. There was no way I'm going to get that approved right now, and I'm sure you're hearing this from a lot of your clinical customers. Financially, it's a rough time for hospitals, for nonprofits, and especially in the LC MassSpec, trying to bring this up in a hospital lab. We really, we've got to watch our output, our money output right now, and there was no way I was going to get that approved. So right now, I'm probably going to go back, and A, there were certain compounds that you could not give us. much. A stability date for, and I pretty much know why, because they're not that stable. And to give them an 18-month stability is probably not going to happen. Those ones I'll pull out, and I will probably wind up making the glucuronide control in-house, and I'll add those to the glucuronide control and just insource that ourselves. So I think that was the 7-aminoclonazepam, definitely one of them. I know CBD and THC can be problematic unless you guys are stabilizing it, probably with something like sodium azide or sodium fluoride. I'm not sure. When I worked for ToxLab years ago and we made our in-house stuff, we would stabilize them with something. And there, I can't remember offhand what the other compounds were. It might have been like mitragynine and 7-hydroxymetragynine, which even... And us, when we buy those from Cerulean as a reference standard, they have a minus 80 storage requirement as opposed to a minus 20 storage requirement. 7-aminoclonazepam has a refrigerator storage requirement as opposed to a freezer storage. So that's when these mixed storage requirements kind of limit your stability on a large mix like that. I understood that. So, right now, I have to regroup with my development person, and we'll probably ask for a quote for a single level for a majority of those drugs, not all of them. The ones that had the limited stability, we're either going to ask for a separate quote for, or we're going to just have to make them ourselves. The other option was we are trying to work with Cerulean as well to make just a giant spike for us. let's That we can just crack an ampule and dilute and make our QC just verify the law of the ampule. Yeah, makes good sense. 14:15 - Nicole Miller Just so I can get my variance to it, I know that we have this quote 5817, which is the single level, the high QC. Is that already the paired back list, or are you talking about pairing back more from what's on that list of analytes? That one's 51 analytes. 14:29 - Cassella-Mclane, Gina It might pair back a little bit. I want to take a second look at it before we ask you guys to make this and make sure it's absolutely correct. Okay, Because we're also working with another company to make our calibrators, and I have to make sure that they're aware of these limiting stability factors for some of them as well. I don't know if they're aware. Okay, I used to work. for a reference lab years ago, I'm a reference material lab, so I'm thank I'm familiar with formulating and such, so I know the limiting factor here. Yeah. 15:08 - Nicole Miller Just a question, too, on that one. I know we quoted it as the high panel. It's in urine. Is that the high panel? Are you, like, diluting down? Sometimes customers will make that stock, and then the stock is already a higher concentration than what they're diluting down to? Or is the high panel, like, that is your high level that you would run this as your high? Okay. 15:28 - Cassella-Mclane, Gina So, I'm probably going to go back, and most of these will probably become, instead of $10,000, $2,000. Okay. I'm not sure. That's why I wanted to look at it one more time before we agreed with you guys. 15:46 - Nicole Miller Okay, because… It might stay this way. 15:48 - Cassella-Mclane, Gina It depends on how we… This would be our stock that is going to then get diluted into QC3, QC2, and QC1. So, essentially, this would be a stock that might not necessarily… Really get run by, on its own, it would get run in a diluted fashion. Got it. 16:06 - Nicole Miller So that's kind of what I was getting to, is that if you are able to reduce those concentrations, that will help with reducing the cost as well. At some point when we get to these really high concentrations, like the economies of scale, even for like increasing volume to be a larger pool, really kind of disappears because as volume increases, the amount of analyte that needs to go in increases at the same rate. So that is an option. I mean, we also have a list of like, basically what is the main drivers of the cost for our end, that sometimes customers will choose to just remove, to say like, if this is the main drivers of cost, remove these two analytes off of it. That, if that is an option, like we can provide that like top five most expensive analytes that are in it, if you want to assess those ones too. Okay. That would be good. 16:51 - Cassella-Mclane, Gina Okay. Because, but I might look at this, there's only a handful of analytes that need to go down to like. A 5-nanogram level for QC. Like fentanyl, norfentanyl, acetylfentanyl, those are the ones that we care about, the super-duper low levels, buprenorphine, norbuprenorphine. Everything else, you have a QC somewhere around 50, that's usually going to be adequate for a low level. And then your mid and your high should be somewhat representative of your AMR range. And those we can be a little bit more flexible on. We're going to be more concerned on these low-level ones. This is not meant to be an overdose panel like we currently run. This is meant for making sure people are taking what they're supposed to be taking and not ad-libbing. Yeah. 17:47 - Nicole Miller Makes sense. So yeah, if there is any opportunity to reduce those concentrations down, that will significantly help with the price reduction too. 17:55 - Cassella-Mclane, Gina Okay, excellent. 17:59 - Raleigh Gallina (UTAK Laboratories) Awesome. Awesome. So I have an action item from that portion of conversation. We'll go ahead and get over to you the highest cost analytes to see if that's something that you're interested in removing. Does that sound about right? Yes. 18:17 - Cassella-Mclane, Gina I mean, it might wind up as two stocks, ones that are going to be the higher concentration ones, ones that are low. It might be something like that. And then we dilute it down how we need it. Yeah, makes sense. 18:34 - Nicole Miller Perfect. 18:37 - Raleigh Gallina (UTAK Laboratories) Awesome. Well, Gina, was there anything else while we have you here that you wanted to ask or that we could help with? I think that was it right now. 18:47 - Cassella-Mclane, Gina If the synthetic serum option sounds much better for the endocrines. So if you can send that along, I will test that as soon as I get it and we can move along with that. Yeah. Dang. Yeah. As far as the drug stuff, I'm going to take another look at that next week and get back to you and kind of give you a different listing and get that quartered out as well. I'm probably also due for our current, the 3181 and 3182, we're probably due for quotes for those because I'm probably going to have to order soon. If you wanted to look at those two and give me an updated quote so I can put in a PO for those. Gotcha. 19:38 - Raleigh Gallina (UTAK Laboratories) We're also waiting on a xylosine QC from you guys. 19:41 - Cassella-Mclane, Gina I don't have the PO offhand. I'll have to get back, I'll have to email that off to you. We're waiting to see how close you guys were to sending it. 19:57 - Nicole Miller Doesn't sound familiar to me but I can check real quick to see if I see. you. Yeah, anything, and if an order's been in yet. 20:04 - Cassella-Mclane, Gina Because we had put in an order for it, and then it was taking a while. We made an in-house for now to hold us over. Yeah. Again, we prefer to have the external QC. Yeah. 20:18 - Raleigh Gallina (UTAK Laboratories) Yeah, and obviously we don't love to hear that, too. I'm seeing a xylozine order entered, but that's from, like, this time last year. No, there should have been a recent one. 20:33 - Cassella-Mclane, Gina I put the order in a while ago. Okay. 20:35 - Raleigh Gallina (UTAK Laboratories) Yeah, Nicole, I don't know if maybe you're seeing something different than what I'm seeing. No, correct. I only see the open order for the steroid controls currently. 20:44 - Nicole Miller Okay. 20:45 - Raleigh Gallina (UTAK Laboratories) Well, sorry about that, Gina. Let me go ahead. And I'll locate the PO in the meantime. 20:52 - Cassella-Mclane, Gina Perfect. Yeah. 20:53 - Raleigh Gallina (UTAK Laboratories) So, we'll work on our end to see, you know, where the breakage was. And if you could also, if you have that communication handy, if you could. Just send that my way. I'll make certain that that gets in and give you that confirmation as well. Sorry about that. Okay, no worries. 21:07 - Nicole Miller Raleigh, for your records, it looks like we have a current quote that's 5767 for xylosine controls, though. So I'm assuming it's that, but that'll help us come to track down on our end, too. 21:19 - Cassella-Mclane, Gina It'll be three levels. 21:21 - Nicole Miller Yeah, that's what I was saying, too. 21:24 - Raleigh Gallina (UTAK Laboratories) Okay, so at least we have the quote number that we can track down on our end, too, so that's helpful. Thanks, Nicole. All right. Well, anything else, Gina? That is it. 21:38 - Cassella-Mclane, Gina Awesome. Well, I did want to give a note of gratitude. 21:41 - Raleigh Gallina (UTAK Laboratories) Like, this is exactly the kind of partnership that UTAC loves, and just this open communication, this candor. And so a huge thank you for being communicative, for being educational, and then also hopping on the call with us. So we appreciate it. 21:57 - Cassella-Mclane, Gina No worries. Awesome. 22:00 - Raleigh Gallina (UTAK Laboratories) Hey, well, you'll hear from us shortly, and have a beautiful weekend. You too. Thank you very much. 22:06 - Cassella-Mclane, Gina All right. Thanks. 22:07 - Nicole Miller Bye-bye. Bye.