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Emma Melendez Scherer - October 15 VIEW RECORDING - 12 mins (No highlights): https://fathom.video/share/Kywtybn9eGGY8V1vYvxu_ich-svTdjpd --- 0:00 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Took a second to set up on this computer. Oh, you're quite right. 0:03 - Andrew Hartmann (UTAK Laboratories) It gave me another minute to warm up my voice. don't know if you ever did music classes as a kid where you had to do like that Do-Re-Mi, Fossil-Block-E. 0:11 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Literally. It was like having a different time zone. I just rolled out of bed about an hour ago, so I've been... Oh, man, I'm sorry. Oh, no, no. It's totally cool. 0:21 - Andrew Hartmann (UTAK Laboratories) I actually, I love these early meetings because like my home office is two hours behind me. So like normally it's like 10 o'clock my time before I ever get to talk to somebody. Oh, there you go. 0:30 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Yeah, I like to just get it done early. Yeah, I'm a big fan of that as well. 0:34 - Andrew Hartmann (UTAK Laboratories) I appreciate you making a little time to hop on here. Yeah, of course. 0:39 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) We can just go ahead and dive in. 0:40 - Andrew Hartmann (UTAK Laboratories) So we kind of took the information that you and I talked about. We also looked at the last time that we started kind of talking about this with Northwestern Memorial and kind of merged some of the design factors together. So just wanted to review everything with you. So we're going to be doing three levels. This product... It does require a baseline sample. So the way it would start if you order it is we first send you a sample of the blood before we've done the manufacturing. You're going to test it. 1:10 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) You're going to tell us where it's at for Fath. 1:12 - Andrew Hartmann (UTAK Laboratories) Now we'll hope to find a negative, but to be direct, that is often rare. So typically what we're looking for is just to establish the baseline value. And then from there, depending on what that value is, we either dilute down or spike in. Or if the value is like extremely high, we might say like, hey, you know, let's go with a different sample. But typically with PATH, we see people diluting like up into the over 90% at times and still having good response. So usually we do dilution with PATH. Okay. 1:45 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Is that, you know, do people usually only test the baseline once? Do they, you know, do 10 points, 20 points? What's the standard there? 1:54 - Andrew Hartmann (UTAK Laboratories) Or I think by and large, most people are just giving us one value, but we really kind of. Leave that up to you and what you think as far as like your method. I do know I've seen a lot of customers also do like two to three runs. I can't say I've seen like 10, 20 runs on a baseline. It's usually anywhere from like one to three is kind of typical, but one by far is what we were used to seeing. Okay, sounds good. 2:19 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Yeah, because we have varying retention times on our mass spectrometer for this assay. So like it'll go down over time. So for my own personal, you know, I would probably do like five points. So like a week of runs, if that's okay, and give you guys an average. 2:40 - Andrew Hartmann (UTAK Laboratories) Our form is going to tell you to get us the results back in 10 days. But to be honest, that's just kind of like an ask, not a requirement. So if you need more time, if you want to run it, you know, multiple times, you're more than welcome to do all of that. Okay. So for fill size, we went ahead and just set it at a mil. That's approximate. That's approximate. Approximately a week's fill size based on your usage. Quantity-wise, we put it at three packs, so that would give you approximately 18 months based on your 52 ml a year. This is going to be your price per pack, extended pricing for all the packs, and then kind of everything with shipping, handling, dry ice, all of that included there. 3:23 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Okay, perfect. 3:24 - Andrew Hartmann (UTAK Laboratories) We'll be putting in the PATH. We do not have official stability data on PATH, so it doesn't mean that it won't work. It just means we don't have the data we would need to make a claim for you. We've got your concentrations here, just to double check, make sure that we have all of those right. And then our guarantee is typically plus or minus 25% of your target. So, for instance, 200, we would expect your results to be anywhere from like 150 to 250. 3:51 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Yep. 3:53 - Andrew Hartmann (UTAK Laboratories) Special note, just about the red analyte, again, stability data is we just don't have the data to claim. We are not using our... We're going to use the K2-EDTA whole blood, which is what your test is running off of. It's going to be a frozen form QC, so really easy to use. You'll just pop it out of the freezer, allow it to thaw and come up to room temperature, swirl, and it'll be ready to use. Okay. It's be in a 2ml silenized amber glass vial, and then you had different label colors on the last time we did it, so we just mirrored that this time. So your low will be red, your mid will be blue, and your high will be green. 4:30 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Yeah. 4:31 - Andrew Hartmann (UTAK Laboratories) And then lead time, as far as that goes, once you place the order, approximately 10 days for us to send you that matrix sample. Once you get that sample, test it, and get us back the results, you're looking at about 15 business days to receive the final product. 4:45 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Okay. Is it, I mean, I know you don't have a lot of, you know, you don't have a stability claim, but probably would be okay in the refrigerator thawed for a week, for five days? I suspect so. so. I Okay, mean, that's how we do our QC, too, is, you know, we have it frozen, we thaw it, use it for a couple days, and then discard. 5:07 - Andrew Hartmann (UTAK Laboratories) Yeah, the anecdotal feedback I've gotten from other customers is that stability on this largely follows kind of our normal frozen stability of about an 18-month shelf life and around 20 or 25 days of refrigerated stability. However, I have heard from a few people that they find storage at negative 80 is better than storage at negative 10. 5:28 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) And, again, we don't have a claim, so that's just more of like, hey, some people tell us it's better, other people say it's fine. 5:36 - Andrew Hartmann (UTAK Laboratories) So, you know, just kind of sharing that information for what it is and, you know, do with it what you will. 5:41 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Yeah, we have a minus 20 and a minus 80 as well. So, and then, so I know that last time that they, I wasn't even working in this lab yet, but they had ordered PATHQC from you guys. This was, was like six or seven years ago at this point, and they had found. On some interfering peaks, which is why we decided not to continue. So I guess my question is, like, in terms of, like, customer feedback, are you, or, like, have you guys changed anything since then where this could be, you know, not a thing anymore? 6:16 - Andrew Hartmann (UTAK Laboratories) Specifically, I can say that when we hear things like those interfering peaks, it's usually, like, very specific to, like, a certain lot and a certain customer. In the past, when we've had these kinds of issues, like, we used to send it out to, like, other labs, and all the other labs tell us it's fine. But, you know, it's like, when you have a customer having a problem, you can't just go back to them and be like, well, everyone else says it's fine. You know, so it's one of those things, like, it seems like certain lots on certain instruments, for whatever reason, just don't work. But as far as, like, a general statement, we don't see that being an issue. And I believe the last time, you know, I mean, we support our product, so it looks like we canceled the order. I don't think you guys were charged anything for it. 6:58 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Okay. Oh, so we probably just got that baseline. Sample, and then? 7:03 - Andrew Hartmann (UTAK Laboratories) Yeah, possibly. You know, I don't know. It looks like you guys have ordered PATH a couple of times. Okay, interesting. 7:12 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) So. All right. I'll talk to someone that was here during that time as well, just to see if they remember what happened. Yeah, mean, definitely. I'm interested 100% because I want this to work because I'm the one that's making the QC from scratch. So, is it going to be kind of the same thing as the sample matrix where I put in an extra line item? Yeah. So, it's kind of exactly what you saw there on the quote. 7:43 - Andrew Hartmann (UTAK Laboratories) Let me just pull it back up. Because it's a custom product, technically, you don't have to because our team is going to automatically know to. 7:50 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Oh, okay. 7:51 - Andrew Hartmann (UTAK Laboratories) So, this would basically be the four line items you'd want to put on the PO and this MTX baseline, that's that sample. And then you'll see it's just at zero. 8:00 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) good I 8:00 - Andrew Hartmann (UTAK Laboratories) So definitely if you can include it, please do. It's helpful. But in this case, there's no way our team would miss it because they can't make this product without giving you the sample. Okay, gotcha. 8:11 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) And then, so we have to, I think I have to place this order like as a special order. Is there, because it usually asks me for like an item description from the manufacturer. Can I just put custom PATH QC for Northwestern, for NWMH, and that should be good for your team to know. I can also reference the quote number. Yeah, reference the quote number would be ideal. 8:41 - Andrew Hartmann (UTAK Laboratories) Like if you can get these product numbers and the descriptions onto the PO, that's like gold standard. 8:46 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) We love to see it. 8:48 - Andrew Hartmann (UTAK Laboratories) If not, it can be as simple as, you know, I want to order PO 5806, or sorry, quote 5806 using this PO number. And, you know, here's my shipping address. 8:58 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) All right. Yeah, I'll try and get the product. Numbers and Descriptions into the, I think I can do where they add a note to the PO. I just don't know if I can get them to do it as a line item for the custom stuff. Everyone's process is different, so we're happy to try to work with you any way we can. We just like to have something in writing just in case there's like a payment dispute or something. Okay, perfect. Yeah, I think we'll try this. You know, hopefully the baseline sample doesn't have any issues, and we can go from there. 9:33 - Andrew Hartmann (UTAK Laboratories) Yeah, I think that'll be a good indicator to kind of see what the baseline happens, and if you're seeing that same kind of interference or something like there, you know, let's not proceed until we figure out what that is. But typically with those interference issues, it's like a lot specific, and once you switch to something else, we don't see it continuing. Yeah. 9:52 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) I guess, sorry, I'm just thinking about what my manager might say. Can we maybe just... Change the order quantity to one pack of each level. Two packs would be our minimum order size. pack is the minimum. Okay. To get to that 50 amount. I could change that. 10:12 - Andrew Hartmann (UTAK Laboratories) If you'd like to, just a heads up, it could change the price per pack a little bit since our pricing is based on quantity. 10:17 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) But if you'd like me to add an option, I don't mind doing that. 10:20 - Andrew Hartmann (UTAK Laboratories) We can show you the two pack pricing and the three pack pricing. 10:25 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) No, it's okay. I mean, we can just leave it at three then. I'll just talk to my coordinator. I just know that they might be like, you know, we don't know if it's going to work or not. And then, you know, we'd be out $7,500 if it doesn't work for us. If they do share any concerns with you, please just connect with me and we'll talk about it and see what we can do. 10:48 - Andrew Hartmann (UTAK Laboratories) Because I'd love to see you guys, you know, getting into this. 10:51 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Yeah, me too. I'm trying to convince UTAC to make a stock product for it. 10:56 - Andrew Hartmann (UTAK Laboratories) So the more of it that we can sell as a custom, I think the better of an argument I have. I've done. done. So more more more To get a stock product made. 11:01 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Yeah. Okay. Yeah. I'll email my coordinator and just let him know. I mean, I definitely want to try and go ahead with this if we can. But yeah, I will. let you know what he says and connect with you. Perfect. 11:16 - Andrew Hartmann (UTAK Laboratories) And I'll email this over to you right after we get off here so you'll have a copy of it. 11:20 - Melendez Scherer, Emma (Northwestern Memorial HealthCare) Awesome. Okay. Thanks so much, Andrew. Yeah. I appreciate your time. Have a great morning. Thanks. Bye-bye. Bye.