00:00 – Dr. Nicholas Sanford: I’ve heard some physicians talk about treating chronic UTIs, kind of like peeling an onion. You’ve got to knock it down one layer at a time until it’s able to recolonize to a
00:11 – healthy state. Melissa: Hi. Welcome back to the live UTI free Channel. My name is Melissa, and this is part two of our interview with Dr. Nicholas
00:18 – Sanford, the Vice President of Medical Affairs and Assistant Lab Director at MicroGenDX. We covered the different types of UTI
00:24 – testing in part one. In this video, we’ll discuss antibiotic resistance and how to interpret test results and treatment recommendations.
00:31 – We have a lot of information about UTI testing on our website, so we’ll be sure to share some links in the video description.
00:37 – If you enjoy these videos and want to support what we do, be sure to hit subscribe and tick the bell so you’ll be notified of our
00:43 – future videos. Thanks again for joining us on this journey to making change in women’s health. [Intro music] Let’s
01:00 – talk a little bit about antibiotic resistance. Can you explain the difference between the way in which MicroGenDX reports antibiotic
01:06 – resistance and the antibiotic susceptibility testing conducted as part of the standard urine culture?
01:12 – Dr. Nicholas Sanford: Yeah. So ASTs or susceptibility tests are using cultured isolates to determine the susceptibility and the
01:21 – minimum inhibitory concentration. So, they’re predicated on having a positive culture first and foremost. Antibiotic resistance testing
01:31 – or ART uses PCR to detect known antibiotic resistance genes. So,
01:37 – an AST is going to rule in treatments for you when cultures are positive. Resistance test is going to rule out treatments regardless
01:48 – of a culture result. Mm-hmm. So, I think that’s the big difference in how I explain what they are is you know, resistance testing
01:56 – is creating a scenario of avoidance where the AST is inclusion.
02:02 – Melissa: Yeah that’s a really good way to look at it. The other question is if it does detect antibiotic resistance genes, does
02:08 – that mean that antibiotic will not work or that it just might be less effective than others?
02:13 – Dr. Nicholas Sanford: Well, I don’t know if I can really say. What we can say when it’s detected is that we know it’s there.
02:19 – Melissa: Mm-hmm. Dr. Nicholas Sanford: We don’t know if it’s being expressed or not, and it’s certainly possible that it’s not being expressed. Say
02:25 – you’ve got a quinolone resistance gene not being expressed, and then you throw a quinolone at it. Well, quinolone might cause
02:31 – the gene to be expressed. Melissa: Right. Dr. Nicholas Sanford: So, I would say if you’re going to be targeting
02:37 – something for which resistance is present, I would avoid those compounds.
02:43 – Melissa: Okay. A lot of people asked if you have any plans to implement susceptibility testing alongside the antibiotic resistance genes.
02:51 – Dr. Nicholas Sanford: I don’t think so. ASTs require that positive culture up front. Melissa: Hmm. Dr. Nicholas Sanford: Cultures are negative far too often. I
03:00 – think this is probably something we will do in the future but we’ll be leveraging whole genome sequencing data in order to predict
03:08 – these phenotypic sensitivities. So, that’s something that’s still a ways off, but I think it will give us AST-like information without
03:18 – the culture dependent testing. Melissa: Okay, you might have answered this question already, sort
03:25 – of in what you said, but are the antibiotic resistance genes detected and the recommendations that come from those ever tested alongside
03:32 – susceptibility testing, so that you can compare how accurate they are?
03:38 – Dr. Nicholas Sanford: So yeah, we still need to do some some work there. But I think on the report you’re referring to the antimicrobials
03:45 – for consideration. Melissa: Mm-hmm. Dr. Nicholas Sanford: And you know that is data that is, it
03:50 – looks a little bit like an AST but it’s not. What it’s showing you is wild type sensitivities for the organisms we’ve identified
03:58 – and those sensitivities are published in either the Hopkins or the Sanford guide. So that’s not data that we’re generating.
04:04 – Melissa: And in the case of polymicrobial infection where an infection is caused by more than one organism, are the resistance genes
04:10 – detected a reflection of the group resistance or of each individual organism?
04:16 – Dr. Nicholas Sanford: So, because we’re doing this two-part test to get an identification and the resistance profile, we can’t
04:23 – physically link a resistance gene we detect to any specific organism. But we know that we need to in some form of fashion. So, what
04:31 – we’ve done is correlated certain resistance genes, the ones that we’re targeting with certain bacteria that they’ve been found
04:40 – in, and this has been established in the literature. You can see a table on the second page of our reports that shows which resistance
04:48 – genes corresponds to which single species or which genera. So,
04:54 – there’s a table there that explains who goes to what. Melissa: Can you estimate what percentage of tests your lab processes
05:01 – that are polymicrobial infection? Oh, I mean, the stark majority
05:07 – of them are gonna be polymicrobial. A lot of the research we’ve done, in PJI and urology, even in nails, it is showing that a
05:19 – majority of these infections are polymicrobial. Mm-hmm. Yeah, it’s sort of a complicated topic, but it also shows the limitations
05:27 – of standard culture where the results often just report one organism. And now we’re seeing that that’s unlikely to be the case for most
05:34 – people. Dr. Nicholas Sanford: Mm-hmm. And even repeated cultures. I mean, if the organism that’s being missed is one of these that is unculturable
05:42 – – Melissa: Mmm-hmm. Dr. Nicholas Sanford: Maybe it’s viable, but not culturable, maybe it doesn’t grow on the media that we have available. I mean, you
05:49 – may never see it. Melissa: Mm-hmm. Yeah. It’s an issue, I think, for a lot of people in this community, and probably one of the reasons people end
05:57 – up with this long-term recurrence because things are being missed. Dr. Nicholas Sanford: I believe so, I believe so. I think it’s better
06:03 – to have more information than less. Melissa: Yeah, I think most patients would agree. When you do provide
06:09 – information on resistance genes, is that on all test results or only on those done within the US?
06:15 – Dr. Nicholas Sanford: So, the resistance gene testing is available everywhere. The antimicrobials for consideration are not.
06:22 – Melissa: Mm-hmm. Which regions do you provide those recommendations for? Dr. Nicholas Sanford: So, we’ll provide them in the US as long as
06:30 – the sample comes with a clinician signature. Melissa: Mm-hmm. Dr. Nicholas Sanford: We
06:36 – don’t provide them currently in the state of New York. Melissa: Okay. That’s because of a difference in regulation?
06:42 – Dr. Nicholas Sanford: It is. It is. New York is a clear exempt state. And they have just slightly different regulations, but we are
06:50 – working with them, trying to get that included. Melissa: A lot of people have asked about whether in the future,
06:57 – patients might be able to receive those antibiotic recommendations without a clinician’s signature. Do you think that will ever be
07:02 – possible? Dr. Nicholas Sanford: I don’t think so. It’s a regulatory requirement to mitigate patients self-prescribing outside the guidance of
07:10 – a healthcare professional. Melissa: I figured that was the case. It’s always worth asking though.
07:16 – On to the results now, how long does it take for you to provide results once a sample has been received by the lab?
07:23 – Dr. Nicholas Sanford: So, our level one results are available within 24 hours of sample receipt at the laboratory.
07:29 – Melissa: Mm-hmm. Dr. Nicholas Sanford: And the level two NGS is available in 3 to 5 days. Our average on the NGS is three and a half days.
07:37 – Melissa: Mm-hmm. Dr. Nicholas Sanford: It will sometimes go out to five days because we’ll see something on the original 16S PCR. But the sample won’t
07:47 – make the thousand reads to meet our threshold. Melissa: Hmm. Dr. Nicholas Sanford: So, we’ll try running it again on a larger
07:53 – cell. This kind of generate a lot more data. And so, when we do
07:58 – that repeat testing, that’s what can take it out to five days sometimes. Melissa: Okay. So, just to clarify, level one is PCR and level two
08:05 – is NGS. Dr. Nicholas Sanford: Correct. Melissa: Do patients receive level one while they’re waiting for level two? Or do you wait and send them all at the same time?
08:12 – Dr. Nicholas Sanford: We send the level one out first because it’s got the PCR information and PCR isn’t just a resistance genes.
08:19 – It’s also got some of the common organisms that we’ll see in that given sample type. So, it provides kind of a rapid preliminary
08:27 – result to show you here’s some things that we’identified that are common neuro pathogens that you wanna look at.
08:35 – Melissa: Mm-hmm. Dr. Nicholas Sanford: And then the NGS, like, we would love to have it come to you all at once very rapidly. An NGS just takes a little
08:42 – bit longer. And this is because the process, it includes sample prep and there’s a couple hours for that. Then once we get the
08:50 – sample on the sequencer, depending on the cell, the flow cell you’re using, it can be up to 55 hours of sequencing time.
08:58 – Melissa: Mm-hmm. Dr. Nicholas Sanford: And then that’s followed up by several hours of bioinformatic analysis. We are working to develop some metagenomic
09:08 – options that we’re aiming at a 24 hour turnaround time on that.
09:13 – Melissa: That would be great news for patients when that happens. Do the results indicate which organisms are considered to be pathogens
09:19 – versus those that are considered beneficial? Dr. Nicholas Sanford: They do not. And I think the biggest reason
09:26 – for that is because we don’t have patient history. We don’t know if this patient is being tested because they are trying to find
09:34 – out what’s causing the infection or – Melissa: Mm-hmm. If they’re trying to do a test of cure. So, we
09:40 – don’t presume to know what this report is telling us. Mm-hmm. Dr. Nicholas Sanford: We leave that up to the physician to interpret.
09:49 – Melissa: Yeah. That does make sense from that perspective. How do you determine the low versus medium or high bacterial load?
09:56 – Dr. Nicholas Sanford: So, that’s done with a PCR test. It’s a 16S PCR. And what we’re doing is just determining low being less than
10:06 – ten to the fifth copies per ml. Medium is anywhere between ten to the fifth and ten to the seventh, and high is greater than
10:12 – ten to the seventh. And, you know, what we do is with this PCR assay, to figure that out is we run a bunch of standard curves
10:19 – for all kinds of different organisms. And we do this to try to account for the copy number variation of 16S, because we know
10:28 – that even within species or between species, you can see different
10:34 – copies of 16S. So, that bacterial load isn’t absolutely quantitative
10:41 – but semi-quantitative. Melissa: Okay. And is that really there to guide clinicians because
10:47 – they’re used to seeing that kind of thing or do you think it has relevance to how they make their decisions?
10:54 – Dr. Nicholas Sanford: I think it is important to know, I mean, if you’ve got less than ten to the fifth, it might still be something
11:01 – that you need to take a look at. But if you’ve got greater than ten to the seventh, that is obviously a big red flag.
11:11 – Melissa: Okay. Do you see on some test results that there’ll be a high bacterial load of something that is considered beneficial,
11:17 – like lactobacillus? Dr. Nicholas Sanford: So, that’s a good question. I do know that
11:22 – on vaginal swabs, we see lactobacillus very frequently. I don’t
11:28 – know if we see it in a high bacterial load. Melissa: Mm-hmm. A few people asked whether good bacteria are just
11:36 – deliberately not identified because it’s not part of the process or if you think that they’re just not there in most people that
11:42 – do this test? Dr. Nicholas Sanford: Well, this just goes back to what the test is trying to do. So, in a microbiome test, you would expect to
11:50 – see all of those beneficial things there but because we’re trying to zero in on what’s causing infection, we’re looking at who’s
11:57 – most abundant, who’s most dominant and everything that’s falling
12:02 – under 2% relative abundance is getting thrown out because these are things that are so low in abundance. They’re similar in abundance
12:12 – to our reagent contamination. Melissa: So, it’s kind of just considered background noise? Dr. Nicholas Sanford: Yeah.
12:17 – Melissa: Is it normal for bladder organisms to change over time and for test results to also therefore be different each time?
12:24 – Dr. Nicholas Sanford: Absolutely. So, these changes over time like we mentioned before, your diet, your health status, whether you
12:33 – have an infection or not, maybe you have an infection elsewhere in the body, medications you’re taking can alter this. Your environment
12:41 – can alter it. We know that it changes as a function of age. So, we know that it’s very dynamic over time.
12:48 – Melissa: And you mentioned it may be beneficial if you take a sample where you don’t have symptoms because it might represent your
12:55 – normal urinary microbiome. But if that changes all the time, how can you ever know what’s normal for you?
13:02 – Dr. Nicholas Sanford: So, I think if you were doing a test designed for monitoring the microbiome, it wouldn’t be such stark differences
13:09 – from sampling event to sampling event. Melissa: Mm-hmm. Dr. Nicholas Sanford: And this would, of course, depend on the frequency of sampling
13:17 – because we get asked about it quite a bit. We are in the very early stages of developing a new product, and it would be a microbiome
13:24 – test – Mm-hmm. Specifically for monitoring your various microbiomes
13:29 – over time. And you can use this just to help with report interpretation
13:35 – later when you do have an infection, you can see who has suddenly shown up or who is out of balance all of a sudden. You could also
13:43 – look at it to see how your – like if your diet is improving things.
13:51 – Mm-hmm. There are some studies out there that say certain bacteria might be associated with colorectal cancer. And changing your
13:58 – diet – Melissa: Mm-hmm. Dr. Nicholas Sanford: Can help push that in a different direction. So, that’s kind of what we’re looking at. And, as is our policy,
14:08 – we’ll try to make that something that’s available for as many sample types as we can.
14:13 – Melissa: Okay. Yeah. You’ll have to let us know when that becomes available. Another question on the changing urinary microbiome
14:19 – or changing test results. After someone does do a test and with symptoms, how long are those results valid for? Because sometimes
14:27 – we hear from people who have their results and they can’t find a clinician, it might take a month until they see someone that’s
14:33 – willing to look at the results. Dr. Nicholas Sanford: So, I don’t have an exact answer for that,
14:39 – but I certainly wouldn’t act on a result that I’ve had in hand for a week or two.
14:44 – Melissa: Mm-hmm. Dr. Nicholas Sanford: I certainly wouldn’t act on anything that was collected before I had a course of antibiotics.
14:53 – So, I would recommend having that physician or some kind of prescriber
15:00 – lined up beforehand and let them know that this is the test I’m doing and, you know, just
15:07 – so that they’re ready for it. Melissa: Mm-hmm. Dr. Nicholas Sanford: Now, one thing that’s happening, and it’s gonna happen very soon, I think maybe this weekend, we’ve got
15:16 – a new website that’s dedicated to patients. Our previous website was very physician- focused.
15:23 – Melissa: Mm-hmm. Dr. Nicholas Sanford: And we did that because we want physicians to be able to understand what this test does, how it can help
15:30 – and what the limitations are. But we get more and more requests from patients saying can I buy this test? And for a long time,
15:41 – I think, maybe we didn’t do very much direct-to-consumer simply because what are you gonna do with this result after the fact?
15:49 – Melissa: Yeah. Dr. Nicholas Sanford: So, part of trying to ameliorate that a little bit, we’re gonna be working with a telehealth company that is
15:58 – gonna be able to treat based off of our reports. Melissa: Mm-hmm. Dr. Nicholas Sanford: So, if you were to go to the patients.microgendx.com,
16:04 – order a test kit there, you’d have access to a telehealth service that
16:10 – could also act on your report for you. Melissa: That’s really helpful for patients. We can announce that once it’s ready and share the link in the video description.
16:18 – Dr. Nicholas Sanford: Absolutely. Melissa: So, you touched on this already. But if there are multiple
16:23 – organisms listed on the results, is there any indication on the results which one could be causing the symptoms?
16:30 – Dr. Nicholas Sanford: So, no there isn’t. But you or your physician has likely ordered this test because you’re experiencing symptoms
16:38 – of an infection. And typically the dominant organism on the report is going to be the offender because it’s outcompeting all the
16:46 – other beneficial bacteria, and your body’s responding to that with symptoms. There may be cases where certain organisms are
16:53 – always treated regardless of their abundance like if you see chlamydia, that’s gonna get treated.
17:00 – Melissa: Mm-hmm. Dr. Nicholas Sanford: There might also be cases where you see a few, 3 or 4, maybe even five organisms there, and your clinician
17:07 – doesn’t wanna treat it. And that could be for various reasons, you know, to include those organisms might look like part of your
17:14 – normal microbiome. Melissa: Yeah, it’s a complicated topic. It helps to work with a clinician who has a good understanding of it and experience treating
17:21 – based on these types of results. And we’ve been talking a lot about picking up many organisms. But does it ever happen that
17:29 – a microGenDX test is negative? Dr. Nicholas Sanford: Oh, absolutely. We never know if this is a
17:35 – good thing or a bad thing because we do get samples that are tested for cure [Unconfirmed] but I think in terms of our negative rates
17:43 – for urine and semen, it’s about 16% of the tests come back negative. And for vaginal swabs, it’s about 1% negative rate.
17:53 – I think we’ve touched on it a little bit, but those negatives might occur because there’s inhibitors in the sample. The organisms
17:59 – might be below the limit of detection or the DNA is highly degraded. Melissa: Mm-hmm.
18:06 – Dr. Nicholas Sanford: Sampling is also very important. If you didn’t get any organism in the sample then it’s gonna come back negative.
18:12 – Melissa: When that happens do you recommend that people retest? Dr. Nicholas Sanford: I think so. I think it’s something that may
18:18 – be discussed with your doctor because NGS does have a very high negative predictive value, meaning that if NGS is negative, then
18:28 – it’s reliable. Now, the reason I say involve your doctor is because it could be an issue with the sample collection. It could be maybe
18:37 – time of day. It could be some other etiology. Melissa: Mm-hmm. Dr. Nicholas Sanford: So, these are things that we don’t have information
18:45 – about. So, that’s something that you have to discuss with your doctor. Melissa: Okay. So, looking at the report can you explain the antibiotic
18:54 – recommendations and what the letters and the ticks mean? Dr. Nicholas Sanford: Sure. So, if we’re looking at that antimicrobials
19:02 – for consideration, I said that this looks like an AST. It is not. Those checkmarks are just indicating that a wild-type E. coli
19:13 – has been shown to be susceptible to aminoglycosides. Melissa: Mm-hmm. Dr. Nicholas Sanford: If you see like we’ve got information about
19:20 – gram stain and respiration on there, there is a key at the bottom of the first page of the report that shows you what all those
19:26 – abbreviations are. When resistance is detected, there won’t be any checkmarks. Those boxes will be grayed out. Mm-hmm. And the
19:35 – text will be highlighted in red. There will be an R for resistance there, kind of indicating to the physician like you wanna avoid
19:41 – using this compound because resistance is present. Melissa: And the IV and PO letters underneath that?
19:48 – Dr. Nicholas Sanford: So, that is just the route of administration. So, one is intravenous and one is oral.
19:53 – Melissa: And I see the antifungals listed at the bottom of that report page. Dr. Nicholas Sanford: For this particular example, there was a Rhodotorula
20:02 – mucilaginosa detected. And for that you know, it has been shown
20:07 – to be susceptible to Flucytosine and Ampho B.
20:13 – Melissa: So, you do provide recommendations for antifungals as well. That’s helpful to know. Can microGenDX provide a referral for
20:19 – a clinician who can interpret the results and prescribe appropriate treatment? Dr. Nicholas Sanford: Yes. On the top right corner of our reports,
20:26 – there is a QR code you can scan, and it will take you to a page where a physician can book a peer-to-peer consultation.
20:35 – Melissa: Okay. And if someone does have treatment prescribed but then it fails to clear the infection, do you recommend testing
20:41 – again? Dr. Nicholas Sanford: I believe so. We’ve learned with these chronic
20:48 – UTIs that sometimes they require a test-treat-test again approach.
20:53 – Melissa: Mm-hmm. Dr. Nicholas Sanford: And this is because on that first round of testing, you identify a dominant organism, and then, you successfully
21:01 – target it with some kind of intervention. But now other organisms which were previously kept in check by that dominant organism,
21:09 – they have room to fill the gaps, so to speak. Mm-hmm. I have heard some physicians talk about treating chronic UTIs, it’s kind of
21:17 – like peeling an onion. You’ve gotta knock it down one layer at a time until its able to recolonize to a healthy
21:24 – Melissa: state. Right. And some patients have indicated that they wouldn’t mind paying
21:31 – out of pocket for this type of testing if they could be certain that it will help. Have you conducted any outcome studies to indicate
21:38 – what the success rate might be of using your test? Dr. Nicholas Sanford: Sure. So, our CEO has been highly committed
21:46 – to research and showing the clinical utility of this test. And I think over the years, we’ve accumulated over 70 publications
21:54 – on the technology. As far as outcome studies go, we don’t have a whole lot there. You know, they’re big, complex, expensive.
22:02 – Melissa: Mm-hmm. Dr. Nicholas Sanford: But we’ve done two that I’d like to talk about. One was published by McDonald et al. in 2017, and what it showed
22:11 – is that NGS based treatments outperformed culture and sensitivity based treatments, as evidenced by better symptom scores and higher
22:20 – detection rates. In 2023, we published another study that was
22:25 – looking at NGS guided prophylaxis for patients undergoing lithotripsy procedures. And what that study showed is that NGS significantly
22:35 – reduced post-op infection rates from 8.5% to 0%. It also improved
22:43 – antibiotic selection and it reduced healthcare associated urinary infections. So, those are two very good studies, I think, that
22:51 – really demonstrate the power of the technology. Melissa: Yeah. Dr. Nicholas Sanford: It’s kind of funny that Michael Lewis [Unconfirmed]
22:58 – study, in 2023, that looked at lithotripsy, it kind of blew us away and it had a little bit of trouble getting
23:05 – through review because a lot of people have a hard time believing that there were no infections.
23:10 – Melissa: Yeah, I can imagine that would have been the case. Dr. Nicholas Sanford: There was in that paper, just in case anyone
23:15 – goes to read it, you will see a modified intent to treat analysis
23:20 – in that paper that shows NGS had an infection rate of 1.3%. That
23:26 – is because one patient did not receive the NGS recommended antimicrobials.
23:32 – Right. And they went on to develop an infection. Melissa: Yeah, that’s an interesting study. We can also share the link to that if you can send it over.
23:39 – Dr. Nicholas Sanford: Absolutely. Melissa: Some clinicians have issues with NGS and they say that
23:45 – it detects DNA from bacteria that has already died. Can you speak
23:50 – to that? Dr. Nicholas Sanford: Sure. Molecular tests can certainly detect DNA from dead organisms, non-viable organisms.
24:00 – Cell-free DNA, though, is susceptible to degradation by nucleases.
24:05 – And we’re using thresholds in our testing to prevent or mitigate the reporting of DNA coming from non-viable organisms. So, those
24:14 – thresholds are the sample first has to make at least a thousand sequencing reads. And then for anything to be reported from that
24:21 – mix of reads, it has to represent at least 2% of the relative abundance. Melissa: Okay. Dr. Nicholas Sanford: We find that does a pretty good job of filtering
24:29 – out DNA coming from those non-viable organisms or low-level sample
24:34 – contaminants. It is a little bit more pronounced in very low biomass samples.
24:40 – Melissa: There’s one more question about antibiotic resistance. So, people often say they don’t have antibiotic resistance. It’s
24:46 – not detected on tests. And then suddenly it will show up at some later point in time and have asked whether antibiotic resistance
24:53 – can develop over time or diminish as well. Dr. Nicholas Sanford: Certainly. Antimicrobial resistance develops
25:01 – under the selection pressure of repeated exposure to antimicrobials.
25:06 – The disappearance of resistance genes can happen naturally, cellular
25:12 – upkeep is expensive. And if it’s not being exposed to something for a long time, it might say, I don’t really need this anymore,
25:20 – but that said, in a clinical context where you’re sampling maybe two weeks apart, a month apart, something like that, I think if
25:28 – you’re seeing something disappear, it’s more likely that some intervention has gotten rid of it. If you see something up here
25:36 – between sampling, it could be one of those scenarios where a dominant organism in the previous test was keeping it in check that was
25:44 – treated, and now this new organism can proliferate. Melissa: Do you often see that with repeat tests, that the organism
25:51 – that was potentially the culprit initially has disappeared, and something else is now a high bacterial load?
25:59 – Dr. Nicholas Sanford: Oh, yeah, yeah. We’ll see that quite often. Melissa: Have there been any large scale trials to compare sequencing,
26:05 – PCR and standard culture? Dr. Nicholas Sanford: Well, there have been a lot of studies of
26:11 – diagnostic accuracy comparing the three methods, and they mostly have the same outcome. And that’s that the molecular methods are
26:19 – significantly more sensitive than culture and sensitivity.
26:24 – But NGS kind of wins out because of the cultivation bias of culture
26:31 – and sensitivity and the panel bias of PCR. The other thing and what you commonly hear, the biggest objection
26:40 – to NGS is that it’s going to report too many things. Melissa: Mm-hmm. Dr. Nicholas Sanford: Yep. And these are gonna be considered false
26:46 – positives. False positives are measured through specificity of
26:52 – the test. So, if you look at all these studies of diagnostic accuracy, comparing them, there is no significant difference between the
27:01 – methods and the specificity of these tests. So, culture has just as many false positives as NGS.
27:07 – Melissa: Mm-hmm. That doesn’t surprise me. So, let’s move on to some of the practical aspects of the test. People had some questions
27:15 – about insurance and clinician adoption. So, a lot of people have said that many clinicians are skeptical about testing beyond standard
27:23 – culture, which we know has many inadequacies, as we’ve discussed. How is MicroGenDX tackling this problem and raising awareness
27:30 – among clinicians? Dr. Nicholas Sanford: So, we have a national sales force that goes out and visits physicians at their offices and in the hospitals.
27:39 – We also are working hard on social media trying to get our presence
27:45 – out there. We attend all of the major medical conferences. And
27:51 – we do, not just the major national ones, but we also go to a lot of local regional conferences as well. I think, of the biggest
28:02 – thing that we’re trying to do to reach the clinicians themselves is our research. So, we invest a lot in these studies. And I think
28:11 – right now we’ve got about 40 that are ongoing. So, that’s what
28:16 – we really try to do. It’s just not just reach out to them and say, hey, we’ve got this cool test. We like to reach out and say,
28:23 – we’ve got this cool test, and here’s some data about it. Melissa: Mm-hmm. Dr. Nicholas Sanford: You can find a whole lot of information on
28:28 – our website. I also like to encourage all of my friends and family,
28:34 – like if you go to your doctor for an infection, ask them if they know about NGS, first of all.
28:40 – Melissa: Mm-hmm. Dr. Nicholas Sanford: I think a lot of physicians are starting to become more familiar with it. Covid helped in one way and that
28:49 – everybody now knows what PCR is. Melissa: Mm-hmm. Dr. Nicholas Sanford: So, I think we’ll start getting there to where
28:56 – there is a little bit more understanding of what the test is, how it works because this is still not really even taught in med
29:03 – school. Melissa: Yeah. Dr. Nicholas Sanford: So, it’s new to a lot of people and changing
29:08 – medicine is difficult. Melissa: Mm-hmm. It does take a long time. And, I mean, that’s another
29:13 – question too, changing insurance companies. Can you provide any insight into whether insurance companies do cover MicroGenDX testing?
29:22 – Dr. Nicholas Sanford: Yes. We are covered by Medicare and our PLA
29:27 – code is on the Medicare fee schedule is payable code. We do have a team working to get that PLA code added to as many other fee
29:35 – schedules. So, it’s covered by as many insurers as possible. We’re
29:43 – reaching out to insurance companies now and giving them a copy of the IDSA guidelines that are now recommending NGS for a lot
29:50 – of infection types to try to combat this denial for it being investigational
29:58 – or experimental. Melissa: Yeah, I think that’s really important step to take. A lot
30:03 – of patients can’t access testing just because of the cost and because of the lack of insurance coverage. So, it’s a big deal.
30:10 – Mm-hmm. Are patients able to get in touch with MicroGenDX if they have questions about their results or specific questions about
30:17 – treatment options? Dr. Nicholas Sanford: Absolutely. We have a very knowledgeable customer service team that can answer just about any question you throw
30:26 – at them. And if for any reason they can’t, the call will get escalated to me or someone else in the technical staff to go ahead and answer
30:34 – that for you. Melissa: Okay. That’s great to know. And we got some questions about international shipping and testing. Some of this information is
30:42 – on our website, but I thought it would be worth covering while we have you. Is it possible to order microGenDX testing outside
30:48 – the US? Dr. Nicholas Sanford: It is. Our testing is currently available through labs in the UK, Canada and Peru, and we’re in the process
30:57 – of establishing labs in Germany, Brazil and Dubai. At the moment
31:03 – we’re not shipping to China, excluding Hong Kong, Africa, India,
31:08 – Russia, Ukraine and Hungary. Melissa: Okay. And when you say you have labs in those other countries,
31:14 – does that mean the samples do not get shipped back to the states? Dr. Nicholas Sanford: Yeah, they’re gonna be processed. It’s
31:23 – a little bit – it’s set up differently in the different places. So some of it comes to us, some of it is an actual facility being
31:31 – set up there – Melissa: Okay. Dr. Nicholas Sanford: So, that it won’t have to ship as far. Melissa: Mm-hmm. Dr. Nicholas Sanford: I think eventually the idea is to have a few
31:39 – labs located around the world to mitigate the shipping time.
31:44 – Melissa: Yeah. Dr. Nicholas Sanford: And they would all be MicroGen labs or it would be a lab that’s, you know, licensed our technology. And
31:52 – when we do that, we will go send a team to train them up, show
31:57 – them how to run our test basically. Melissa: Right. Dr. Nicholas Sanford: And usually the analysis is something that
32:03 – would be done over the cloud. Melissa: Okay. That will make a big difference to patients if they
32:08 – don’t have to pay international return shipping. Dr. Nicholas Sanford: Absolutely.
32:13 – Melissa: How does that work at the moment, though, for samples that do need to be returned from international regions? Do you provide
32:20 – instructions in a way for patients to organise that through your website? Dr. Nicholas Sanford: Well, a little bit. So, patients can choose
32:28 – their own carrier for return shipping. We found that Fedex may not be the best option in some countries.
32:34 – Melissa: Okay. Dr. Nicholas Sanford: We do provide customs documentation, and Canadian patients still have the option of purchasing a return Fedex label.
32:43 – I must say that we’re not responsible for any delays or issues at customs.
32:49 – Melissa: Yeah, I think that could be an issue in multiple countries. And we did get a few questions from the UK about whether MicroGenDX
32:57 – may be covered under the NHS at some point in the future. Is that something that you’re working on or will ever be possible?
33:03 – Dr. Nicholas Sanford: That would be great but we haven’t had any of those discussions so far. Melissa: Okay. And the same for the Canada Public Health System.
33:11 – Will it be covered under that at some point? Dr. Nicholas Sanford: I don’t know. Again, we’d love it to be, but
33:17 – it’s not a discussion we’ve had yet. Melissa: Are you aware of any insurers outside the US that cover
33:24 – MicroGenDX? Dr. Nicholas Sanford: I am not. Melissa: Can you provide any references for patients to share with
33:29 – insurance companies that deem the test as investigational, and therefore won’t cover it?
33:34 – Dr. Nicholas Sanford: Sure. We have a section on our website that’s dedicated to insurance denials.
33:40 – Melissa: Okay. Dr. Nicholas Sanford: So, we have our CMS PLA code, which means that Medicare Part B or traditional Medicare covers our test.
33:49 – Calling the test investigational is just a way for insurance companies to get out of covering the test.
33:56 – Melissa: Mm-hmm. Dr. Nicholas Sanford: Medicare Advantage plans are supposed to follow CMS guidelines and cover the same tests as traditional Medicare.
34:03 – They choose not to. Patients have been successful in fighting the advantage plans and getting coverage.
34:09 – Melissa: Okay. Dr. Nicholas Sanford: And we provide all those tools on our website. Melissa: And a few patients asked if they can just help in general
34:15 – with getting insurance companies to cover this type of testing? Dr. Nicholas Sanford: Absolutely. Write to your insurance company
34:21 – and demand that they cover your test. Tell them about your journey of suffering and how many cultures have you had done. How many
34:28 – antibiotics have you taken. Melissa: Mm-hmm. Dr. Nicholas Sanford: You can also go to change.org and sign Carrie
34:34 – Anne’s petition. Melissa: Yeah. We’ll definitely put that link in the description.
34:40 – Well, that brings us to the end of our questions. I wanted to thank you again for sharing your time with us to get them all
34:45 – answered. Dr. Nicholas Sanford: Well, thanks for having me. It’s been fun. Melissa: Thanks so much for watching. I hope part two of this interview
34:51 – provided you with new insights about UTI testing. If you’d like to learn more about this or related topics, be sure to check out
34:57 – our other videos or head over to liveutifree.com for more articles related to this video. We’ll also add some links in the description.
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35:09 – Thanks so much for watching. And until next time, keep asking questions and pushing for better solutions..