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Chris Wolski (00:12)
Welcome to Clinical Lab Chat, part of the MedCorp podcast network. I'm Chris Wolski, Director of Business Intelligence for CLP. And today we're talking about the new diagnostic guidelines that are aimed at improving testing access for women. So joining me once again, I think, is Dr. Jeff Andrews, a board certified gynecologist and Vice President of Global Medical Affairs for Diagnostic Solutions at BD.
Jeff, it's good to have you back yet again. I think you're our regular.
Jeff Andrews, MD (00:40)
This
great to be back. Lots of action happening to improve prevention of cervical cancer, which is great.
Chris Wolski (00:47)
Yeah, and that's what I'm looking forward to talking about that. Now, last time we did spoke about a partnership BD and MD Anderson in Texas had in implementing BD's Onclarity Assay. Now today we're going to discuss another big milestone for Onclarity and more importantly for women's health. So let's get into that. So it was announced in January that the BD Onclarity HPV Assay
has officially been added to the American Society for Collapses-copy and Cervical Pathology, enduring risk-based management guidelines. So that's, you know, kind of a mouthful, but I think that, I think that's very, very impressive and I think very good. So that sounds really great, but what are these, the ASCCP guidelines?
Jeff Andrews, MD (01:37)
Yeah, great thanks. So yeah, it's the American Society of Coposcopy and Cerebral Pathology, but from now on we'll just say ASCCP. So they give input into the screening guidelines, but they own the management guidelines. So if a screening result is abnormal, ASCCP has the screening guidelines. In the past, these guidelines used to be...
Chris Wolski (01:45)
Thanks, thanks.
Hmm
Jeff Andrews, MD (02:03)
algorithms that were on paper or in a booklet. And so in the clinics we used to flip through 30 pages of guidelines to see which algorithm applied. Just full disclosure, I was the Chief Medical Officer of ASCCP from 2013 to 2016 before I joined BD. And during that time we decided that we needed to move to an online version
Chris Wolski (02:10)
Right.
Jeff Andrews, MD (02:26)
an app and also that we needed to go to enduring guidelines. So in the past guidelines were supposed to be updated every three years. Typically most medical societies ended up stretching it to five just because it's a voluntary activity and so what was happening was guidelines were out of date. So ASACP decided we can have an enduring guideline, we can put it on an app and we can update it very quickly.
Chris Wolski (02:44)
Mmm.
Right.
Jeff Andrews, MD (02:51)
So
in 2019, they released the first version of the Enduring Guideline, which was also available as an app or on a tablet in the flow of a clinic or a doctor's office. And you could also pull it up on a computer if you were so inclined. So at that time, the guideline had coverage for what we call partial genotyping. So if you knew that the HPV was 16 or 18,
Chris Wolski (03:12)
Okay.
Jeff Andrews, MD (03:17)
you could input that and you would get a different recommendation from the guideline than if it was the other 12. And we'll catch up in a second, but what's happened more recently is extending that genotype advice beyond just 16-18. So about a year ago, ASCCP updated that 2019 guideline with dual-stain P16-KI67.
Chris Wolski (03:32)
Mmm.
Jeff Andrews, MD (03:40)
staining. And then as you said in January they added extended genotyping. They've already posted on their website that self-collection has gone to the publisher so that guideline will come out online probably in April. Behind that they're doing another guideline for obesity because the national, the U.S. National Cancer Institute has a lot of evidence that obesity impacts the sensitivity of both
happen HPV, so there's going to be some advice around that. And then following that is one for vaccinated populations because we've been vaccinating for a number of years now, so we're going to see those patients entering the screening population. So that's the story about ASCCP guidelines and what happened with the change for extended genotyping. Instead of managing that group of 12 genotypes, the ones that are not 16, 18,
Chris Wolski (04:08)
Hmm.
Okay.
Right.
Jeff Andrews, MD (04:33)
instead of managing them all the same. If you know that the genotype is 56, 59, or 66, those patients don't require immediate follow-up. They can be managed with a simple repeat test one year later. So if the first test was...
clinician collected, they could opt for either clinician or self-collect. If the first test was self-collected, again, one year later they could either do a clinician collection or a self-collection. So it reduces the burden on the patient and the system for unnecessary follow-up testing.
Chris Wolski (05:04)
Right.
Right, potential overtreatment too, right?
Jeff Andrews, MD (05:14)
over certainly over over testing you know more co-pays more more churn in the system hopefully it wouldn't lead to over treatment but it's certainly could if either the patient or clinician was anxious
Chris Wolski (05:14)
Yeah, which
Over-testing, for sure, yeah.
Yeah.
Yeah, well, and this is a really interesting point too, because it also falls into, there was another survey that came out, I don't remember if it was BD or if it was another group I received recently, that women don't schedule cervical tests, cancer tests, in many cases because of, and we've talked about this in the past as well,
You know, scheduling, you know, you have to take off work or you have to go to a different clinic or all the different aspects that could be, know, variables that could be involved with that. And this seems like this would also streamline that too. It would also help to encourage the test to begin with, right?
Jeff Andrews, MD (06:20)
It would, Chris. So there's personal reasons to put off that appointment. There's the competing obligations that you mentioned. And then there's also people who, because of a change of job or temporarily not having a job, there's been a change in their insurance, so they need to postpone for that reason. So in the US, there's a lot of reasons, living in a rural area, all types of things.
Chris Wolski (06:29)
Right.
Right.
Yeah, right. And we've touched on some of that as well. I also, I just want to back up with the app. What I think is really interesting, you know, I remember and I think I've mentioned on the show and I don't know with you, but with others that, you know, I come from a medical household. My mom was a nurse for 50 years and she had all those manuals, all the various manuals, et cetera. And she'd have to buy new ones from time to time for, you know, for various types of things that she needed.
And an app just seems much more efficient, particularly for this kind of test, because you can update it and revise it. as you pointed out, now you can easily add in guidelines for, we have been vaccinating for all these years. How do you test for a vaccinated person? do you, self-collection, the other things are, and some of other.
things we're going to be talking about in a minute here. It just seems like the app, it seems like it makes it much more dynamic, much more useful both for the clinician and the patient as well because you're going to get a real picture of what's going on with the correct updated algorithms, right?
Jeff Andrews, MD (07:53)
Yeah, so I used to be an academic and when I was at a medical center, I think from memory 14 or 15 years ago, we started issuing tablets to every upper level medical student, every resident. And that's how they function now because the EMR is on the tablet. So why not put the other assistants there, the explanations of things, the guidance for things, the guidelines.
Chris Wolski (08:11)
Right.
Jeff Andrews, MD (08:17)
put that all in the same place so it's right at your fingertips.
Chris Wolski (08:21)
Right, right. And it's not, and this is one of these great, really becomes a tool then. And it's not, you know, it's relying on a robot to tell you things. It's giving you real tool to be able to test and allow you to be a physician and doctor and help people. Yeah.
Jeff Andrews, MD (08:40)
Yeah,
if you're familiar with it and you trust it, you can just see the recommendation and go with that. If it's new or you want to understand, you can keep clicking and see the evidence beneath that recommendation for yourself or to explain it to your patient.
Chris Wolski (08:55)
Right, right. So let's talk about, let's back up a little bit. Let's talk about in terms of on clarity as an assay. What is this, it being added into the ASCCP during risk management guidelines. What does that mean for the assay? mean, does that give physicians, know, pathologists and laboratories another...
tool to add to the menu or another test to add to the menu or to make it easier to order? What does that mean for the assay itself?
Jeff Andrews, MD (09:24)
So right now in the US HPV is used to triage after if someone's had a PAP test and it's atypical squamous cells of undetermined significance or ASCIS, HPV can be used to see if that's positive or negative. HPV is used as part of co-testing where the clinician orders both a PAP and an HPV from the get-go and it can be used for primary.
Chris Wolski (09:34)
Right.
Jeff Andrews, MD (09:47)
testing where HPV is done first and only if it's positive do we go on to cytology. So there's basically four companies that have approved assays by the FDA in the US and of those four assays only on Clarity has the extended genotyping. So this guideline that came out is quite specific to on Clarity.
Chris Wolski (10:09)
okay. So, yeah, okay. So that would make it, again, it specifies the algorithm for that particular test. You're not trying to fit a square peg in a round hole, as it were, in other words.
Jeff Andrews, MD (10:25)
years ago or more, the US National Cancer Institute started noticing risk differences between the genotypes that are in all the HPV assays. So BD decided to provide that utility with the assay to add additional information about the genotypes, if you will, to break out the other 12 into individual reports in small groups.
Chris Wolski (10:49)
Right.
Right.
Jeff Andrews, MD (10:49)
And so
that initially there wasn't a guideline, obviously, but now there's a guideline that specifically takes advantage of that differential and risk. So just to give you an idea, if you have HPV positive and you do cytology and it's normal, there's a 60 times difference in risk of pre-cancer between HPV 16 and HPV
that I mentioned before. If you do the cytology and it's abnormal but it's mild, so it's either ascus or low grade, there's a 20 times differential between the worst genotype, 16, and the lesser risk genotype. So we can make use of that risk differential for precision medicine.
Chris Wolski (11:20)
Okay.
Okay, okay, great. All right, something we've talked about before is self-collection for cervical cancer. That was something we talked about last time we spoke. Now, the ASCCP guidelines also support the use of self-collection methods for cervical cancer screening. We just mentioned that. So I've been thinking about this a little bit since our last conversation, we're getting ready for this one. Explain how important...
it is to have that diagnosis to the access to that continuum of care. Because, know, we talked about this, I think, you and I have talked about this. It's great to have a treatment, and I've talked with this others, it's great to have a treatment, but if you don't have an adequate test, or if you're not testing at all, okay, it's a dead end. So, how important is it for this, you know, for the have these diagnoses and particularly having, you know,
updated guidelines, accurate guidelines, guidelines specific to the tests for diagnosis to have that access to the correct continuum of care, either watchful monitoring or, you know, more invasive treatments.
Jeff Andrews, MD (12:41)
Yeah, Chris, as we talked before, most of the cancers that happen in the US occur in women who haven't been screened. So we're trying to figure out how to reach that proportion of women, is 25 to 30 % of the women in the US. And we know from other countries' experience that offering self-collection is one of the ways of doing that. So that's very important.
Chris Wolski (12:56)
huh.
Jeff Andrews, MD (13:06)
We're in a temporary stage now where we have self-collection available at a, at a healthcare site, meaning your doctor's office, your lab, that sort of thing. But the ultimate goal is for at-home collection and for your podcast listeners that are tuned into this, there've been articles in the last year or two, editorials with different key opinion leaders saying that, yeah, it's nice to have the in-clinic collection, but we really need.
Chris Wolski (13:19)
Right.
Jeff Andrews, MD (13:33)
at home collection and in other countries where at home collection became opt-in available, kind of through us that became the dominant preference. I think we're looking at a future in the United States where self-collection in the home environment is commonplace and preferred by a majority of women and we're trying to get there.
Chris Wolski (13:53)
Yeah.
Jeff Andrews, MD (13:56)
The FDA is collaborative, the National Cancer Institute is collaborative, the National Institute of Health has provided a grant for research to support this effort. As you know, research in the lab area has to be done very carefully and it takes a few years, so we have to be a little patient, but I understand the demand for this.
Chris Wolski (14:16)
Yeah, and more to the point, I know you're... I guess, and correct me if I'm wrong here, or...
in terms of this. The MD Anderson program is still going on, that correct?
Jeff Andrews, MD (14:30)
It is, Chris.
That's an implementation study because, of course, the self-collection is approved, cleared by the FDA. So it's an implementation to understand all the different things you have to do as a federally qualified health center to communicate with patients, to get the instructions in English and Spanish, to get the samples back, to get them to the lab, to communicate the results, to show how the whole thing works.
Chris Wolski (14:36)
Right.
Jeff Andrews, MD (14:56)
That can go to all federally qualified health centers and other centers that are interested in that challenge. And I think we spoke before that FQHCs don't have an obstetrician gynecologist on site every day, every hour. So very helpful to them to be able to offer alternatives.
Chris Wolski (15:10)
Yeah. Yeah.
Yeah, and do you know, do you have any sense at this point how, because I know that we talked about the last time that the population mentioned that it's bilingual in many cases. Many of the patients are either underinsured or not insured or don't have great access to, haven't had great access to care in the past. Has this helped to motivate?
patients to come in and get tested? What is your sense of how the self-collection option is helping to reach some of these 25 to 30 percent of women who aren't getting tested?
Jeff Andrews, MD (15:53)
It definitely has motivated the clinic staff at Sioux Clinica, which operates five or six clinics there in southern Texas. And the program itself is getting going. The lead person, Dr. Jane Montalegra, was in DC at a forum last week. And so things are piping along. We've had inquiries.
the availability but as I said before we're geared toward trying to get the at-home collection going.
Chris Wolski (16:24)
Yeah, okay. And how is this, how does the new guidelines, et cetera, certainly it's helping clinicians as we were discussing. How about labs? How are the new guidelines helping labs in particular?
Jeff Andrews, MD (16:40)
think labs keep track of what's happening in the clinical space. So they'll be considering are they able to offer extended genotyping? Are they able to offer self-collection? And they'll be kind of watching that space to see how they need to develop in that area in terms of adding testing capability. Some labs are already quite familiar with at home.
in the sense that they ship swabs and whatever to patients' homes and get them back. Others may be thinking of this as a new development, but I think when we came through COVID and then STI testing, I think it's a familiar space for the labs.
Chris Wolski (17:04)
Mm-hmm.
Yeah.
Yeah.
Yeah, I think it just seems to me, I mean, looking at looking now and ahead and some of the new there's been a couple of new FDA at home tests or tests that have been approved by the FDA for I think STI just recently. And it seems to be that that really seems to be the future of testing in terms of reaching people and in terms of
of getting people diagnosed properly. Yeah, okay.
Jeff Andrews, MD (17:49)
Yes, you're right. It
is the future to some degree. I mean, I think we got a little excited during the end of COVID. Some people were forecasting everything will be done with self-collection and self-testing. I think there's limits, but certainly for respiratory infections, sexually transmitted infection, and now hopefully for HPV, this will be quite popular.
Chris Wolski (18:01)
right, right, right.
and there's also that, you know, and part of the, part of that survey that I was mentioning, what I thought was really interesting, and I think that sometimes we forget about, is the psychological aspect. You know, we're dealing with people, you know, they, not just symptoms, not just, you know, a set of symptoms or a...
organs that we have to test to make sure they're working properly. So I think at home testing, particularly for some of these key tests that we're talking about, HPV, STI, etc., it seems to me that those are natural at home test options. I certainly don't want to do blood draws on myself at home, but if I needed to have a COVID test, having the COVID test at home,
was a lot more convenient than having to stand out the urgent care clinic on the sidewalk with my mask on feeling terrible, waiting for someone to come and swab me. So it just seems like they're, I think this is why these things, it's a case by case and certainly convenience factor and then, you know, in case of HPV or I think there's a at home prostate test now that I read about and
and STIs, that certainly there's that, there's a psychological factor, know, fear, shame, whatever people are feeling in the convenience of their own home that it might help to motivate them to do that. mean.
Jeff Andrews, MD (19:33)
Yeah,
we're dealing with a couple of stigmas. One is the word cancer. So I'm an advocate for changing what we're doing to say we're screening for precancer, mostly because it's true. We're not actually trying to find cancer. We're trying to prevent cancer, but this is a unique cancer. We can find precancer, treat it. Cancer never comes along.
Chris Wolski (19:38)
Yeah.
Yeah.
Jeff Andrews, MD (19:54)
So that one thing is that stigma and the second stigma is that HPV is sexually transmitted. And so there's a concern about that. So these at home tests will come in a plain brown wrapper or plain white envelope or something. It won't be labeled and it can be exceptionally private and hopefully it'll help people who have those concerns.
Chris Wolski (20:01)
Yeah.
yeah, yeah, yeah.
Yeah.
Yeah, particularly for HPV, you know, we have the vaccine now and that's been around, you know, 15, 20 years or however long it's been around. it's also cervical cancer in particular is very easily treated when found in that precancerous stage. So it just seems really a tragedy if, you know,
women in particular aren't taking advantage of these tests that are very effective and treatments that are very effective as well. So I think this seems like we're moving in the right direction with these guidelines and with OnClarity and self-collection. So I think we're at a very exciting time for the fight against cervical cancer for sure.
Jeff Andrews, MD (21:09)
I completely and thanks for this opportunity to chat with you and your podcast listeners Chris.
Chris Wolski (21:14)
Yeah,
yeah, it's always a pleasure to have you here and I look forward to having you again. But unfortunately, we've come to the end of our time. So again, thanks for joining me, Jeff. And I also want to thank you, the laboratory audience, for listening. Look for more episodes of Clinical Lab Chat in the future and visit us online at clpmag.com and on all the major social media platforms.
So until next time, be well.