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Michelle Blankenship - November 20 VIEW RECORDING - 19 mins (No highlights): https://fathom.video/share/3FK-vpCu724o5XpbqLJ7FRmF3sjHHx7J --- 0:03 - Andrew Hartmann (UTAK Laboratories) Oh, I think you are still on mute there Chandler. I sure am. How's it going? Pretty good yourself? Doing good. There's Michelle. Howdy howdy. Hello. Hello. 0:15 - Chandler Fisher How are things down in Alabama? 0:17 - Andrew Hartmann (UTAK Laboratories) You guys getting the wild weather swings we have up here in Missouri? It's like every day it's a whole different climate. Yeah. I think it's 62 this morning. 0:24 - Chandler Fisher Yeah, it's to be almost near the 80s this afternoon. Yeah. Oh yeah, we're raining in 40s. 0:29 - Andrew Hartmann (UTAK Laboratories) think we're heading on the downhill swing before it gets warm again, but we'll see. Nicole doesn't know anything about it. If you don't like the weather in this part of the country, Nicole, just wait a day. It'll be something completely different. 0:43 - Nicole Miller Hey, it goes from like 60 to like 55 on some days. It's wild weather here too. Hey guys, I thought was a little late. 0:53 - Andrew Hartmann (UTAK Laboratories) I guess it's right at 10. I guess I'm not late. 0:55 - Nicole Miller No, you're spot on. 0:57 - Andrew Hartmann (UTAK Laboratories) Thanks for connecting. I just thought spot You know, a conversation like this might just be easier to kind of round up and, you know, talk about what exactly we're trying to do, because I was overlooking your request in the THC issues, and the area where you guys identified of moving the targets for the low level and the high level, I think is exactly the right move. We see this happening... Okay, been... Sorry, go ahead. Go ahead, sorry. 1:22 - Jason Barry Well, I was just going to say, what we're finding is, I get that y'all are within y'all's spec, but whenever y'all's high is coming in on LTMF at 52, using an IA, which can vary up to 10 to 15%, it put us so often where it was actually coming in negative when it should have been a positive that it was unusable. Mm-hmm. 1:42 - Andrew Hartmann (UTAK Laboratories) Yeah, we see a lot of labs kind of doing this technique just to make it for screening, because those machines aren't as precise. So we make products for like, you know, one lab group is like 10 different labs. They all have some different instruments, but they all use the same QC. And, you know, some of their panels, they've moved as far as I think it's like plus or more. So I think that idea is the right move is kind of checking out where we should move these cutoffs to. The area that really gives our team concern is this request for like the 5% plus or minus target for the cows, the 10% for QC. 2:21 - Jason Barry I assume that was going to be a little bit much of an ask as far as the 5%, especially 10%, I wasn't sure. And if we can't meet it, we can't meet it. That's not going to be a sticking point for us. That is why we were looking at, okay, if we can move to 10% and keep where we are as opposed to 20%, then it would probably work. Because if we were getting more of a value that was 58 or something like that, we would probably be okay, maybe even 55. But at 51, 52, constantly coming in low, it just isn't going to work. So either we need to raise and lower the values or we need to tighten that up where it's going to be close. So 3:01 - Andrew Hartmann (UTAK Laboratories) Yeah, because the problem from our perspective, just kind of for transparency, is like, if we just use whole numbers to make it easy to talk math, like, let's say we have a target value of 100, we send this product out to, you know, 100 different labs, and we're going to get results anywhere from some labs telling us it's all the way up to 125, other labs are going to tell us it's all the way down to 75, you know, there's going to be a general consensus of most labs in that 100 range, but it really comes down to, like, well, whose results are right, who doesn't Do you trust? Like, that kind of stuff, because looking at the values that you guys had reported in the technical complaint, and then our third-party values, you know, there's differences there, so it's just, it's difficult for us to say, like, one lab is correct, another lab is, you know, less correct, or something like that, so from our perspective, we really don't like the conversation of, you know, a 5% or a 10% of target, because if we send it to enough labs, one of the labs is going to tell us that we're within, you know, what UTAC spec is, but if the product at the end of the day doesn't work for you, You're not a happy customer. So I think more the conversation to kind of transition to, you know, hey, if we are working within this broad plus or minus 25%, what do we think is the right low target value and the right high target value that if everything is, you know, sticking within that kind of general range, you're going to consistently get negative on the negative and positive on the positive? Yeah. And I think we can make that argument. 4:26 - Jason Barry The, the only issue I even see with it is that some of our higher end labs may, may choose to opt out of it because of it. Because of course they're going to be going, well, you know, for analytical values, they should be plus or minus 20% of the cutoff. And so the problem being, obviously, if we're using UTAC and we're plus or minus 20% of the cutoff, so we're, say, like you said, let's use whole numbers if we're, our cutoff's 100. So they're needing to be at 80 and 120. For analytical purposes, for their laboratory specs, their lab directors tend to like those numbers as a QC cutoff. But y'all are plus or minus 25%, then from lot to lot, we may get ones that cross that cutoff and they can't use it. So that's where I think if we broaden the range, we can definitely use them in our smaller labs, stuff like that. But in our more analytical labs, places that run LCMS and such, they don't like to use different standards for IA versus LCMS. And I don't know that we're going to be able to sell them on it. But for the most part, most of our stuff's been fine. It's really the THC is the only one that we've really had much of a problem. Okay. 5:29 - Andrew Hartmann (UTAK Laboratories) How do you think your customers right respond if instead of like a fixed value, there was more of a range on the IFU? 5:39 - Jason Barry So, yeah, a range is definitely going to be the better way to go as far as it should, like, if you're low as this, high as this. The problem is if you're using 25%, we can't say the range is below the cutoff. 5:50 - Andrew Hartmann (UTAK Laboratories) Yeah, it would actually be more like it would change per lot kind of the way we've done it in the past. So we make a similar product. right. So to this for another company, and what they do is every time we make a batch, we send it to them for the validation testing similar to what you guys were doing, and then they come back and say, hey, for this particular batch on the IFU, I want the mean for each of these analytes to say this, and I want the range for each of these analytes to say, you know, between this and this. And essentially, you know, because of the deviation from lot to lot, you know, there's sometimes like slight changes where it goes from, you know, lot to 95 the next lot to 105 the next lot, so it's, it's, you know, all still very tightly around that, but they do get that, you they provide us a range that we put on their IFU, and from what I understand, that makes it broadly more usable for their customers. 6:42 - Jason Barry makes it more usable for like, and I'll say, the problem is, then we flip the problem, right? And we have the problem with the low-level labs. That they just want a low and a high and stay between it, because they never even look at it again once you put it on. And our high-level labs would love it, but our low-level labs aren't, they're not going, the, the problem. And also our high level up, if the number changes each time, then now they have to do a new validation each time, because they're coming back and going, okay, well now we're calibrating it, this number instead of this number, from the manufacturer is saying it's different, so now I have to do a new validation proving it works. 7:18 - Andrew Hartmann (UTAK Laboratories) Gotcha. Does that make sense? Yeah. 7:20 - Jason Barry So I would probably, I think we're fine with, for the most part, doing a broad range on the QC. I've got no issue with that. In fact, I would love for us to publish a broad range on the QC, and we can provide those numbers that we're thinking. Um, the, the only real issue we have is that in a, like for this one specifically, if we need to increase and decrease it, then that's what we do. we run 25 and 75 instead of running 34 and 65, then, then that's fine if that's what we absolutely have to do. And if we lose a couple of labs because of it, or if they just choose not to run THC, so they'll run individuals on THC, we can live with that. so Thank you. Thank you, you, we can't live with is, I can't put it at 34 and 65, but with a range that falls below and above the cutoff, because we can't tell them, well, technically that's working within spec, but also you're running a negative as a positive. Understood. 8:16 - Andrew Hartmann (UTAK Laboratories) So, I'm thinking, Ben, the shift to change those target values to 25 and 75 is probably our best path forward, and then maintaining that in-process sample. So that way your team has an opportunity to validate it and make sure, you know, it's going to work before we finish off that product. And then we'll keep the range off the IFU for now and just kind of see, you know, see how that plays out. Okay. Yeah, that definitely works. 8:44 - Jason Barry And the other thing, just to be clear, if we were talking about a 10% range, we are talking about a 10% on LCMS, not on our equipment. Like, I understand our equipment's going to run differently, depending on what we're running it on. That's totally understandable. And there we have. It's of a broad range there, but the issue that we have is if we're running on LCMS at the tip of that 20% or whatever, then whenever we start adding in ours, that's when things start getting sketchy. Yeah, definitely. 9:13 - Andrew Hartmann (UTAK Laboratories) Even on LCMS, we still see that kind of variation. So when we make our stock products, we'll sometimes send it to two or three labs, and we'll still see, you know, one lab tells us it's 15% high, the other lab says it's 5% low. So when it comes to, like, our IFU, we just end up averaging those values and putting it on there. Like, we've never really found a product that consistently lab-to-lab runs, like, you know, exactly at the same concentrations. 9:38 - Jason Barry Yeah, there's going to be slight differentiations because of the environment and the laboratory that's running it and their methods for preparing it. Yeah, there's a million things that go into that. 9:49 - Andrew Hartmann (UTAK Laboratories) That's kind of where, like, on our perspective, we're looking for that in-process sample for you guys to run it and tell us how to adjust the concentrations to make sure you're getting the expected performance, you know. At the end of the day, if it's actually coming out at 20 and not 25, but it's working for the method, you know, it's like, I think that's a better method than trying to get like a specific fixed target based on one LCMS. Exactly. No, I'm with you 100%. 10:14 - Jason Barry And that's the only other thing we thought about doing, and I want to get y'all's input on this, is what if we upped our high 10%, but we left everything else alone, because everything else is running spot on. It's only the high that we're having any sort of issue with. 10:29 - Nicole Miller Yeah, mean, from my perspective, I'll jump in here, Andrew. For THC, and for most analytes, they're not going to increase, they're only going to decrease because of the instability. And for THC in particular, it is a relatively unstable compound to be working with. So, for the low, like, your risk is that it's going to go lower, it's not going to increase in values. For the high, if you did just want to increase that one, that would offset, like, any decreases that maybe would be happening at that high level that would be pushing it below the cutoff. Is that something we can do? 10:58 - Jason Barry Because I know with your Q... you see stock, you may be doing a top stock and then dilution. Obviously, we want our Cal stock out of a different stock, but would that be an issue for y'all to be able to do a higher value in our high QC with the standard value in our low QC? 11:16 - Nicole Miller No, so we make all three levels. We spike them all individually. There is no stock that we're using to make all three of them. So yeah, all our three independent spikes. makes it even better. 11:25 - Jason Barry Okay, so y'all aren't making a top stock and then diluting down. Y'all are actually making three separate stocks? Correct, yes. 11:30 - Nicole Miller Gotcha. 11:31 - Jason Barry Okay, that actually works better for us. Yes, if we could do that and just increase the value of the THC by let's say 10%, then that may actually be the answer because we can leave our number where it is and with degradation we'll still be within our values. Because the bottom is coming in perfectly. We're consistently seeing right between 30 and 35 with no issues. Mm-hmm. But the high is where we're having an issue where it's falling, you know, 48, 55, 44, you know, whatever, and it's the cutoff 50 is supposed to be 65. good That's That's So if we up that by, let's say, 10% to 15%, maybe even as high as 15%, 15% might make more sense, then we can see that even if we're in that 25% range, we're still going to fall above the cutoff and it'll still be okay. And it's probably an easier fix, too, because we already have the low and the calibrator kind of dialed in working, so we're just adjusting one. Yeah, that makes sense to me. 12:27 - Nicole Miller Okay, if y'all are good with that, I think I'm good with that. 12:30 - Jason Barry I don't know, Chandler or anybody else, if anybody else has any take on this, but that's kind of where, I think that's what makes sense to me. Yeah, I'm good with that. 12:39 - Andrew Hartmann (UTAK Laboratories) Just so I don't get confused on the math, can you confirm what that high level concentration is? Is it 75 we want to move it to? 12:47 - Jason Barry Yeah, right now it's at 65, so if we're multiplying that by, let's call it 15%, then probably, yeah, 75 is actually perfect, 74.75. So yeah, let's move the concentration. It's 75 on the high, but leave everything else alone. And the reason being because we can still label it as 65, we'll do some testing just to verify, but it seems to me when we've done all this testing in the past that if y'all move y'all's value to 75, it may come out on ours at 65. So it may be a good level to leave it at for us as far as our documentation, but the actual level being a little higher is not a bad thing. 13:27 - Andrew Hartmann (UTAK Laboratories) Okay, so we'll go ahead and update the quote to change that percentage to 75. Okay. I'll send that over once we have it, and I know separately we're having some packaging discussions with our team and kind of reviewing to get that part of it taken care of. 13:42 - Jason Barry Okay, yeah, and I've been pushing Justin to finalize that because it sounds like several of our customers are just literally chomping at the bit to get on this because the individual stuff takes time and money. So. Definitely. 13:57 - Andrew Hartmann (UTAK Laboratories) So we'll get that change going. something. Yeah. And then we'll have to wait until that packaging conversation gets finished out to get pricing and all that for packaging to kind of move forward with the next order. But I think Nicole and her team will be taking the lead on that. So hoping we're able to make some some fast actions there. Yeah. 14:15 - Jason Barry The one thing I did request Justin to push for, although I'm and I don't know if it's possible or not, but y'all currently use different color caps, is that right, or different color labeling? Labels. Yeah. So I'd actually request, I don't know if it's possible or not, but I was real, I love the way that y'all use the different color labeling. And I would love it if we were able to do like a blue and an orange for the high and the low. I just don't know if y'all can change those color schemes or whatever, but just to fall in line with our company colors. But it also, man, being able to look across the lab and know exactly which one's high and which one's low is fantastic. I think we can do blue and peach. 14:56 - Andrew Hartmann (UTAK Laboratories) I'm not sure that we have orange, but I think peaches. can use this. It's close as we currently have. Is that right? Yeah, it's an orangey peach. 15:05 - Jason Barry It's probably better to call it peach anyway, because our owner is obviously an Alabama fan, so he hates when we call it orange. In fact, everything that we have that's orange, you call it sunburst because he hates Auburn. 15:21 - Andrew Hartmann (UTAK Laboratories) If we can work a little college football logo onto the label, is that a value add? Not for most of us, but maybe for him. We'll change the quote, top level QC, we're going to move to 75, and then we'll switch blue label color for the low, peach for the high. And then as far as the cow, you've got red, green, or yellow to choose from. Yellow is fine. 15:52 - Jason Barry Yeah. Chandler, did you have a different option there? No, yellow's fine. think yellow's... Yellow is fine as far as the calibrator goes. I'm not real picky about that one. Even if you want to go white, I mean, if y'all have white labeling, that's fine, too. I'm not real picky, but the low and the high being blue and orange is kind of, well, or peach, is fantastic. That actually works for differentiation and it matches our scheme, so it kind of works out. Perfect. And then also, once this is all completed, I want to get started on our second multidrug as probably as quickly as possible. So maybe in the next month, if we could get together and start planning that one out. Definitely. 16:32 - Andrew Hartmann (UTAK Laboratories) Yeah, you guys have my Calendly link is in any of my signatures. So whenever you want to connect, just feel free to book a meeting. But in order to include Nicole, who's on our West Coast side, if you could just make sure it's after 10 a.m. your time, that way she can join. Yeah, that's not a problem at all. 16:48 - Jason Barry In fact, I prefer afternoon meetings because in the morning I'm always running around trying to find people. 16:54 - Nicole Miller Lovely. 16:54 - Andrew Hartmann (UTAK Laboratories) Yeah, was just telling Nicole I was doing those old grade school vocal warm-ups like the dual rave. Yeah, It's good that Yeah. I'm trying to make sure my voice isn't cracking here. Working from home, I don't talk to anybody until my first call of the day, so you've always got that little voice warm-up you gotta do. Oh, yeah, yeah. 17:11 - Jason Barry No, that works, but yeah, because we definitely, I think there are a couple that we could do different levels of, because we do have some labs that run, like, different levels of amphetamines or whatever, and then also, like, we are running currently where methamphetamine works really well for amphetamine and methamphetamine, but on two of our other product lines, they don't run methamphetamine in their amphetamine, so we need to actually add specific amphetamine as opposed to methamphetamine to be the calibrator and control. So that, that's what I'm thinking is that we can work those in where that would work for that product, or we could do different levels, and then also, obviously, ecstasy and 6am, which don't work, they don't seem to play well with oxycodone and opiate and all that, but if we do a separate one with those, and then the different levels, I think that would work really well. Perfect. Well, it sounds like you guys have already... We've done the R&D that we want on that. 18:01 - Andrew Hartmann (UTAK Laboratories) So I think we should be in pretty good shape to just get the design from you, get a quote, get rolling on that as well. So we can probably mirror the same process. We'll obviously have to check out and just make sure in process sample is good for those analytes. But as long as everything is good, I think we could just mirror the same process for whatever other product lines you're looking at. All right. Yeah, that'd be fantastic. 18:22 - Jason Barry Yeah, I really appreciate it. I'll try to get with you. I want to let them kind of get further along on this and push that one forward so that we can start getting in labs and then we can push on the second level. Perfect. 18:34 - Andrew Hartmann (UTAK Laboratories) All right. Thank you. I appreciate it. Yeah, I'll have these updates made so we capture it and send it over to you. And then once the packaging gets figured out, we'll make a final update to the quote. All right. Perfect. 18:47 - Jason Barry Thank you, guys. I really appreciate your time. Yeah, thank you. Have a great one. 18:50 - Andrew Hartmann (UTAK Laboratories) Bye. Bye.