Episode 61: The Crucial Role of Biomarkers in Decoding Lung Cancer with Kimary Kulig, PhD, MPH

The Patient from Hell (00:01.004)
Hi everyone. My name is Samira Daswani and I am the host of the podcast, The Patient From Hell. I have an incredibly special guest with us today. I've known Kimary now almost a year and a half. She's one of those women who I am truly a fan girl of, by the way. So I feel a tiny bit intimidated today, but also I'm incredibly excited to have her on this episode. Kimary, thank you for taking the time and joining us today.

Kimary Kulig (00:31.534)
Thank you for having me on your podcast, Samir. I have to say, I'm really happy you invited me because this is yet another one of these huge topics in oncology that I'm really passionate about and frankly could talk forever about. And I'm really passionate about wanting to teach anyone who will listen quite frankly about the topic of cancer biomarkers. So.

The Patient from Hell (00:32.396)
Thank you.

The Patient from Hell (00:56.748)
All right, you lied right into it. So maybe we start with just that. So you're known as the biomarker navigator. Can you tell us how you got to having that name?

Kimary Kulig (00:58.894)
Okay.

Kimary Kulig (01:08.878)
Well, it's a self -given title actually, and part of it is because I'm actually trying to kind of coin the term, if you will, biomarker navigation. I think a lot of us have heard about patient navigation and types of patient navigation, and it's becoming more recognized and even reimbursed most recently. But I really feel like there's a niche.

area of patient navigation that for which there's still a really huge unmet need and that is around the area of biomarkers and cancer biomarkers and helping patients make sure they get this really important testing.

The Patient from Hell (01:55.308)
Kimri, I think we need to define a biomarker. I think you're hinted at that. Well, we're talking briefly about the episode. So maybe we go straight in. What is a biomarker?

Kimary Kulig (02:06.958)
A biomarker, and I'll do this in oncology speak, a biomarker is something that can be measured in the body, either in the tumor or in the blood, a molecule. And in oncology, we're mostly talking about genes or proteins that can tell you how the disease is going to behave. And in that case, we're talking about a prognostic biomarker.

So what kind of course is the disease going to take, regardless of what type of treatment you get. And then there are predictive biomarkers. And those are the ones that kind of help inform treatment decision making. So if you have a certain biomarker, you should get a certain drug because we know you're going to do better on it. And this is the class of predictive biomarkers that relate to drug.

prescriptions.

The Patient from Hell (03:08.94)
We didn't do this a lot, I apologize in advance to you and everybody listening to this episode or watching this episode. I believe that this will be one of our more technical episodes. So I may pause, Kimary and ask you for definitions, just because we're entering a part of oncology, and please correct me if I'm wrong on this, that is very fast moving. Our understanding is constantly evolving and it is very...

on the biology of cancer. Fair assessment? Okay. So the reason I say that is I'm in a, in this specific episode, we'll ask for a little bit of like bio one -on -one as well. So I'm going to roll back all the way to the top of what you said. I heard you say in the world of cancer biomarkers, there are genes and proteins. Can you explain genes versus proteins? Just very, very briefly. So.

Kimary Kulig (03:42.574)
Yes, yes it is.

Kimary Kulig (03:52.366)
Mm -hmm.

The Patient from Hell (04:08.588)
we all have a sort of similar understanding of where we are.

Kimary Kulig (04:11.406)
Absolutely. Yeah. So, and I do actually, I have developed material to teach this directly to patients too, because I do think it's really important to make this distinction between a gene and a protein because both of them can be biomarkers. So a gene is really DNA. DNA is the blueprint. I have an analogy where I think of like the DNA is like the architectural blueprint to build something.

DNA is actually, it codes, it gives the instructions to build a protein. So DNA gets transcribed into RNA, which gives instructions for specific amino acids to link together to create a protein. And why it's important to make that distinction is because these

A gene can be a biomarker and a protein can be a biomarker, but they're tested in different ways. So when we talk about testing a gene, biomarker testing that's gene -based versus protein -based, they use different material and different testing platforms.

The Patient from Hell (05:32.332)
Super helpful. So I'm gonna before we sort of switch into how we use biomarkers I'd love to spend a few more minutes on this and in the world of Testing can you help explain genetic testing versus biomarker testing?

Kimary Kulig (05:47.246)
Yes, that's a really important question. And it's one that I find trips up a lot of people. And I think that's partly because in the clinic, it's referred to as genetic testing. And I think that's sort of a result of there being genetic counselors to talk to patients about genetic testing. But genetic sounds a lot like gene. And when we talk about genes and gene mutations,

they can be of different types. So genetic testing, as it's called in the clinic, is really looking at germ line alterations in DNA. And what does that mean? Germ line refers to the origin of the DNA being from germ cells. You get egg from mom, sperm from dad. Those are germ cell lineages. And so when we talk about...

genetic testing or germline mutation testing, we're really looking at what is an inherited gene alteration, a mutation for example, that you got from your parents and it's in all of your DNA, in all of your cells, in your entire body. It's not just in your tumor. When we talk about somatic mutation testing, we're looking at something

that is in the tumor and not necessarily in your germline. It's not in the germline actually. So when you have tumor biomarker testing, you're looking at somatic mutations mostly, but some of those somatic mutations could actually be germline mutations. So you may have inherited them. They could be found in all of your DNA. And...

One thing I'm seeing a lot and hearing a lot and reading a lot about these days is that germline testing, this hereditary testing is underutilized. I've seen cases where a patient has shown me their biomarker test report that shows somatic mutations. And some of these genes that are mutated are the same genes that can be germline mutated.

Kimary Kulig (08:11.95)
So I'll use an example. I had a breast cancer patient. She had a BRCA1 mutation in her biomarker test report. And the first thing I asked myself was, is this a germline inherited mutation or is this just in her tumor? And when I dug deeper into her medical records, I did realize that they did do germline testing on her and it was not a germline mutation. It was only in her tumor.

And the importance of that was, you know, that was sort of a sigh of relief because it meant that her daughter, her sisters, you know, her grandchildren even didn't have to have testing for that gene necessarily based on her history anyway. So that's the difference. The somatic mutation is in the tumor. Germline mutation is in all of your cells, including your tumor cells.

The Patient from Hell (09:09.47)
But can I summarize it in maybe a slightly different way and can you correct me if I got the summary wrong?

If I understand germline was a somatic, germline I am born with, somatic I can get at any point in my life. Is that a fair way to summarize it?

Kimary Kulig (09:29.582)
That's true. Yes, it is. Definitely.

The Patient from Hell (09:35.468)
So it sounds like germ line testing. I essentially have no... Okay, I'm gonna say something and then you may have to correct me. I have no control, like the biology of it, we don't have any sort of control over it. It just exists. You're born, it's there. Somatic mutations can keep changing during the course of the ant's experience.

Kimary Kulig (09:54.51)
Mm -hmm.

Kimary Kulig (10:02.702)
That's true. But just because you have the germline mutation doesn't necessarily mean it's going to manifest as cancer. These are really what we call pre -disposition genes. So you have a much higher chance of developing cancer. And it may involve having what we call a second hit, where in addition to...

having that germline mutation in your DNA, you also have another assault to your DNA, which could be in the form of a somatic mutation or some environmental exposure or something that can also cause the tumor to happen in the first place.

The Patient from Hell (10:46.572)
Got it. Okay. Uh, one more question for you and then I would love to go into an example. Um, the question is genetic testing versus genomic testing. What's the difference is that one, how, how does it matter?

Kimary Kulig (11:06.35)
Yeah, I think the easiest way to answer that question is when we talk about, and if I understand what you mean by genetic testing to be germline testing, you can do that using a saliva sample or a blood sample. You know, it's not a tumor test. In fact, to truly know germline, you need normal tissue to test, not the tumor tissue.

So that's one big difference is, you know, it can be a simple blood test, it can be a saliva test. Sometimes they also, if it's a tumor -based testing, it's possible to do somatic and germline testing at this, you know, with the same sample. But usually they do that by getting some of the normal tissue that's around the tumor tissue to use as the normal comparison.

The Patient from Hell (11:33.164)
Hmm.

Kimary Kulig (11:59.182)
So the test itself is the same thing. It's sequencing DNA, you know, what we call next generation sequencing or NGS, which sequences the DNA. That test is actually the same. It's more of the specimen is different. We're looking at normal cells versus just the tumor cells.

The Patient from Hell (12:21.484)
Okay, I'm gonna add one more summarization and then you can tell me if I'm right or wrong. So the way we test to get to a mutation, any mutation at the genetic level is next generation sequencing. Essentially, we're trying to figure out what the series of codes are, like the alphabet. And the sample...

Kimary Kulig (12:45.006)
Yes.

The Patient from Hell (12:49.676)
we are running that test on is either normal tissue, i .e. fully healthy normal tissue, or it's the cancer tissue.

Kimary Kulig (12:59.022)
Correct. Yes.

The Patient from Hell (13:01.036)
And depending on which sample we're running the test on, we get different information.

Kimary Kulig (13:07.086)
True, yes. And I think the example I tried to bring up before, which is where it confuses a little bit, is that sometimes on the tumor sample, you can find a mutation in a gene that is one of these cancer predisposition genes that you often find as a germline mutation. So good examples of that are like BRCA1, BRCA2, TP53, these tumor suppressor genes, as we call them. And...

It's important to know, and I'm finding this ignored a lot in practice, but it's important to know whether those mutations that are in those genes in the tumor are not also germline and in all of the cells. Because if it ends up being a germline mutation, then the family should be tested. It's called cascade testing. And I think what I'm...

hearing a lot about and seeing is that patients are told, my family doesn't need to be tested because we don't have a huge family history of cancer. And my answer to that is, well, how many of us really know what great grandma actually died of? How much of it was unspoken within family oral history? And I think that the time...

The time is sort of passed where we should be relying solely on this sort of oral report of family history to kick in gene testing. The other really important point I want to make is that, and this comes from a case I just had recently where a patient has a BRCA2 mutation and it was properly found and she had genetic counseling and she followed up.

and she has daughters and her daughters were tested. But I asked, what about your sons? And no one told her like she didn't, it wasn't explained to her that this isn't just a breast cancer gene that you know, this your sons can carry this and pass it along as well. Puts them at risk for certain other types of tumors and it puts, you know, any children that they have at risk as well. So I think that's another really

The Patient from Hell (15:10.22)
Oh, oh, yeah.

Kimary Kulig (15:30.99)
important thing to emphasize is it's not sex specific, you know, it puts everyone at risk no matter what.

The Patient from Hell (15:40.46)
Super, super fascinating. I actually, when you said that about the gender thing, there's also a lot of bias, right? There's a lot of unconscious bias that plays out, especially in breast cancer. So that's actually, I had not thought of it that way. I did wanna, I do wanna use one more example and I'm probably gonna do it really badly. And I suspect some people are not gonna be very happy with me with doing this. I think it's an important one because it comes back to,

Kimary Kulig (15:49.198)
I think so.

The Patient from Hell (16:10.444)
Uh, what I was trying to draw out where in genetic testing at germline, true germline, I am born with it, can't really change it. And then there is this like acquired mutation. It happens at some point in the duration of your life, exposure to toxins. I want to go to lung cancer for a minute because lung cancer, um, is from a scientific lens, I think really fascinating because there, there's so much.

biomarker testing happening now and so many treatments are tied to the results of next generation sequencing or NGS. That one I think is just like a fascinating like nerdy moment for me. It's pretty interesting. But more important than that though for me is in a cancer type where we know that exposure to certain types of compounds, asbestos being one of them,

and or a action, i .e. smoking, does result in an increased risk of cancer. I'm sort of curious as to how you think about biomarker testing with smoking, without smoking, asbestos exposure, no asbestos exposure. Where does germline testing kick in? Where does somatic testing kick in? So just a little bit more in a place where, in a type of cancer where we know,

from the data we have that there is potential for an acquired mutation.

Kimary Kulig (17:47.31)
Yeah, I like to, I say lung cancer is currently the king of biomarkers. There are more validated biomarkers in lung cancer right now than any other solid tumor type. I think breast maybe comes in second, but right now there are 12 different biomarkers per NCCN guidelines that should be, that every patient with non -small cell lung cancer.

particularly adenocarcinoma, non -small lung cancer, should be tested for. And yet we know that 100 % of them are not being tested for that, but that's another story. But your point about smokers versus never smokers or other exposures is really interesting because there is a different sort of genetics or...

signature if you will in tumors from smokers versus never smokers and we're now in this era of immunotherapy in lung cancer and it turns out that those signatures have implications for who who's going to do better on immunotherapy versus who is not.

But let me back up a little bit because lung cancer is sort of an area I've spent a lot of my career working in. I was actually really fortunate to work on the very first targeted therapy for ALK translocated lung cancer when I was at Pfizer and that was the drug Crisotinib or Xalcori. And that's really when I got first exposed to and really interested in biomarkers by the way.

But the number of, I guess let's say oncogene driver mutations, and we should define what that means too. Some of the genes that are mutated that we're talking about, these somatic mutations, some of them are in genes that kind of are like the gas pedal for driving the cancer growth and spread.

Kimary Kulig (20:10.35)
And some genes are suppressors that kind of put on the brakes to a tumor being able to thrive and divide and grow and spread. Most of the biomarkers that we have right now, and we're talking lung cancer, but it's pretty true for other tumor types as well, are in these driver or for these driver mutations. The drugs that we have,

to target these driver mutations are to stop an overactive process. So if an oncogene is driving, putting the gas on the tumor, the drugs that we have are putting the brakes on that same tumor. So if we have an elk translocation and we have a drug that is an anti -elk medicine, it's basically stopping that elk gene.

translocation from giving power to the tumor and energy to help it thrive. These oncogene drivers tend to be more prevalent in tumors in patients who are never smokers. When this all first started coming to fore,

we didn't really know because a lot of the studies that were done in cancer populations, it's a very highly selected denominator of patients, right? So when you have young Asian, never smoking women, the prevalence of an EGFR or an ALK mutation doubles, right? If you just take an all -comer population, prevalence, for example, of ALK is only three to 5%.

So in the beginning days of all this, biomarker testing was sort of, we talked about bias before, biomarker testing was pretty biased in the beginning towards, oh, we really only need to screen young never smoker women for EGFR mutation or ALG mutation because they tend to have it more.

Kimary Kulig (22:32.11)
That's true, but it doesn't mean that if you're an older male, even smoker, you may not also have the same mutation. So that's gotten a lot better. And I think guidelines have helped with that as well. But at this point, I'm not even sure I answered your question at all.

The Patient from Hell (22:52.524)
I was going to make a funny little joke. I was going to make a funny little joke, by the way. So I'm a bioengineer from MIT who studied molecular biology, and I can barely, barely understand enough about biomarkers to ask a question. And I honestly feel horrible for any patient who's having to navigate that today because I mean, I...

I skew really privileged. I have a science background. I understand papers and I can like barely sort of kind of maybe, maybe ask a question, let alone forget, forget about understanding it and making an informed decision. And I think the reason I'm going there right now at this point in the, in the conversation is because we went two feet into lung cancer, right? And there are 12 biomarkers based on the demographic of the population, based on the type of mutation.

And I don't think you said this, but I'm going to put words in your mouth for a second and then you can correct me if I'm wrong, is depending on your test, your treatment's different. And that's the reason I think it matters that your work is one, super important. And two, I think it's super important for patients and family members to understand what we're talking about because treatment decisions are actually being made off of the results of these tests.

Kimary Kulig (24:01.422)
Yes.

The Patient from Hell (24:22.22)
And if they're not being made, they should be made. And I just made a should statement, partly because guidelines have changed and actually require testing because we now do have a lot of treatments that are contingent on the results of these tests. And I would love for you to sort of like explain that a little bit, because I think we need to like put a fine point on that because in the absence of that.

I'm a nerd. I'm happy to like, no doubt on like, uncle jeans and drivers. But I think it's also, I think I want to go back to where you set up the conversation, which was prognostic versus predictive. And somewhere in the pathway, we're going from your family should be tested too, to, hey, by the way, your treatment plan is being determined by the result of this test.

Kimary Kulig (25:21.518)
Yeah. Yeah. It's funny because as you were describing that, I just popped into my mind that I sometimes have described to people that what I do as a biomarker navigator is try to help people avoid just going on chemo. My goal is to help you get a targeted therapy or immunotherapy if it's appropriate. And...

The Patient from Hell (25:21.772)
So I'd love for you to talk about that if that's okay.

Kimary Kulig (25:50.702)
you know, because we are, I think we are at an age in particularly lung cancer, but others as well, where we have the privilege of being able to offer a targeted therapy as a first line option for metastatic therapy. And what we're finding still, and even though, you know, lung cancer is sort of the poster child and the king of biomarkers, we're still finding that,

And there was a really great paper on this recently where only about 60 % of lung cancer patients are benefiting from the targeted therapy. And, you know, there's multifactorial reasons why that's happening. Back in the day, it used to be what we call the tissue issue where there wasn't enough lung cancer tissue to do all the tests or it got used up.

or if a patient enrolled on a clinical trial that required that testing, there was no more tissue left. We've gotten better at that. Now we know there's so many tests that need to be done that we have to take, not just a fine needle aspirate, not just, not a cytology specimen. We need to get a good core needle biopsy that goes a long way. And now we're also in this age where we have blood -based testing, which we can talk about later. But...

So that's not the excuse anymore. And yet it still kind of is. And the other big thing, the big issue in getting these targeted therapies upfront to patients as their first option of treatment is there's a really long lag in the turnaround time between acquiring the tissue. And by that, I mean either getting the biopsy or

finding the biopsy material wherever it lives out there in the community, getting that sent to a testing lab. The lab performing, you know, is highly sophisticated, you know, laboratory tests that they're performing, but there's also really highly sophisticated analytics after the testing. So we're talking about looking at the genes and comparing them to normal.

Kimary Kulig (28:15.47)
comparing them to normal variants. So what is really a mutation that has a pathologic significance that's actionable as we call it with drug therapy. So that takes, that can take from 10 days to I've heard horror stories of eight weeks. And that's the problem right now. When you're a metastatic lung cancer patient who presents at the clinic with brain mets, liver mets and.

you need therapy, you really don't have 10 days to four weeks to wait. And I just recently wrote an article about this and I call it life expectancy spent waiting. I like to remind clinicians, especially when they push back on a timely biomarker testing, that that two week wait time can represent 20 % of a patient's life expectancy at that point.

in time and that is getting used up in this wait time. So what happens in a lot of cases is because of this long turnaround time, a physician will choose to put a patient on chemotherapy just to get something going while we wait for the test result to come back. And if the result comes back and it's a...

driver mutation like an EGFR or something else, you would think you should switch right away onto that targeted therapy, but sometimes that doesn't happen because if the patient's doing okay on chemo, the physician will keep them on the chemo. And then you're basically rendering that targeted first line therapy as a second line therapy. The other issue is that sometimes it's not safe to switch.

from the chemotherapy right to the targeted therapy. And you need a washout period in between, which also is eating up precious remaining life. So it's very complicated. I don't envy lung thoracic oncologists because they have to make these really critical decisions on a daily basis. And there's a lot for them to keep up with. So.

Kimary Kulig (30:35.662)
Yeah.

The Patient from Hell (30:35.948)
I have so many questions. So maybe I can give a tiny bit of context. So we have two of our advisors are thoracic oncologists. So we've been spending a little bit of time in the lung cancer space recently. And I know you know this, but we haven't launched a platform yet. So not everybody knows this, but we build maps for the full cancer experience across different types of cancer. And one of the ones that we've been working on is a lung cancer map. And.

The reason I share that is the precise thing you just spoke about, the last couple of minutes of what you just spoke about, which is if you are a clinician and you have a patient who shows up with metastatic non -small cell lung cancer, and they are presenting with symptoms, and you know that next generation sequencing is going to take 10 days to eight weeks, the odds are you're going to start them on chemo.

And even if the clinician knows that they should do biomarker testing, which is a whole thing we should be talking about because that's not always true. But let's say the clinician knows that they should do biomarker testing. Today's system doesn't actually enable that to be a real choice. And then you didn't say this, I'm just going to put this out there is let's say the biomarker testing now comes back patients on chemo. Biomarkers testing comes back. I heard you say two things. One was.

Kimary Kulig (31:50.958)
Mm -hmm.

The Patient from Hell (32:03.596)
You may just wait to put them on the targeted treatment. And sometimes it's not safe. Sometimes you do need the washout period. I'd offer a third in there, which is the patient side. And sometimes as a patient, you may know you only have so much time.

And maybe you don't want to take the risk. And the reality is operating in that window, we actually, and correct me if I'm wrong, Kimi, but there actually is not that much data, right? The data, the body of data that is patient -style chemo, now you switch within first line is my understanding of it outside of our understanding is pretty limited. So it really comes down now to the art of medicine meets the preference of the patient.

Kimary Kulig (32:53.486)
Yeah, yeah.

The Patient from Hell (32:54.156)
And going back to like what I said a couple of minutes ago is as a patient I barely understand what a mutation is let alone like the decision between targeted treatment meets chemo meets immunotherapy meets How that affects my overall life now if there isn't data how in the world will I come to any? informed opinion or decision

Kimary Kulig (33:18.286)
Yeah. And I think you touched upon something really important there, and that is the patient's preference has to be factored into that. The last lung cancer patient that I helped was tired of waiting around. I mean, he was waiting for appointments to see an oncologist, and he also had brain meds. And the choice had to be made whether to do

you know, whole brain radiation. And they were ready to do that, but he had not even seen an oncologist yet. And then there's me saying, what about biomarker testing? Cause he probably has an EGFR mutation and there are drugs that can cross the blood brain barrier. And maybe we don't need to do that. So it's, it's really, really complicated. But in that case, you know, the patient said, I, I need to do something.

I need to take action. And so I think that kind of helped the whole team, including myself, as someone trying to help him sort of just draw a line in the sand and say, OK, we're going to do this. But the other thing I learned during that experience, and again, you hear all these things and you read all these things, but in my case, when I actually meet it in reality, it becomes like little N of 1 data points for me.

I think what really needs to happen, and I'm going to advocate about this until I'm blue in the face probably, is that there needs to be, especially in lung cancer, what I call reflex testing. So why should we wait for, if a patient has to wait 12 days to see an oncologist, that's just 12 days of lost time. A pathologist is the...

First person to see the tissue, to see the quality of the tissue, to know if there's enough of it for testing, to kind of guess whether it's going to yield the result or not, to figure out how many tests we can get from that sample. They should be the ones I feel ordering the biomarker testing, such that by the time if a patient has waited two weeks to see an oncologist, maybe the biomarker report is already in the oncologist's hands when they see them.

Kimary Kulig (35:38.798)
It literally shaves two weeks off of the inevitable wait time and gives a better chance of getting a targeted therapy right up front versus starting that chemo. And then we're kind of stuck in that trajectory, right or wrong. But I think there are some simple fixes from an operational, like a clinic operational perspective that we could incorporate to help this lag time situation.

The Patient from Hell (36:08.364)
That's okay. I have some with that. I'm going to define reflex testing and then I have a question for you. So just to be clear reflex testing, because I don't think we defined it is essentially you're ordering it effectively at the same time. You're essentially not sequencing the ordering of testing. You're basically saying, we're going to basically order everything now.

Kimary Kulig (36:31.502)
Yeah, well, I think it's more of a, this is a non -small cell adenocarcinoma patient. We know there are 12 biomarkers that need to be tested. I don't really need to ask the oncologist what they want tested, because this is what the guidelines say. And the guidelines go so far as to even say that, you know, gene panel testing should be done. So it's a check -up box. Send it off for NGS. And, you know, this artificial wait time is...

I think it just needs to go away, frankly.

The Patient from Hell (37:06.924)
I think you just said that I think is actually really, really important because I don't think it's just about the reflex test. It's about who is ordering the test. Right. Because I think, I think you said that and I think that's actually a really, really, really important point because, and I don't know if most of our listeners will sort of follow this is today and correct me if I'm wrong, but today the oncologist is the primary individual who's ordering the test. Right. So the oncologist is waiting for the results of biopsy to come back.

Kimary Kulig (37:15.022)
exactly.

Kimary Kulig (37:31.854)
Yes.

The Patient from Hell (37:37.196)
is then doing the analysis you're talking about, which is what type of cancer are we dealing with? Is it non -small cell, small cell, adenocarcinoma, large cell, other types of non -small cell lung cancer. And then based on that, they are then ordering the NGS test. What I'm hearing you say is, hey, there is a gap between the pathologist finishing the biopsy and the oncologist reviewing the results of the biopsy.

Kimary Kulig (37:56.718)
Yeah.

The Patient from Hell (38:07.966)
there is a time lag. And if the pathologist could just order the test, that time lag effectively drops away. Did I hear that right?

Kimary Kulig (38:15.918)
Yeah, you did. I'll just make one tiny correction to it. That is it's not only the time lag between the diagnosis being final, like the final pathologic diagnosis and the oncologist seeing that.

What's happening now is their patients actually have to wait to be seen to have a clinic appointment with the oncologist. So it's like, they won't even order the test in some cases until they've eyeballed the patient and taken a medical history and understand it. And, you know, again, I went with this patient that I tried to help. I'll get really detailed here because I think this is important and it highlights the type of work that I do on behalf of a patient.

The Patient from Hell (38:45.772)
Yes.

Kimary Kulig (39:01.614)
I get really detailed. I get into their pathology report, not just the biomarker report. I read the pathology report. And in this particular case, I read a notation by the pathologist that said, you know, this was a bone biopsy, which is not the best type of tissue to send out for NGS because it needs some chemical processing before you send it out. But...

He, he, the pathologist made a notation saying there were, there were a small, and I won't use his technical language, but he basically said that there weren't enough tumor cells in the sample and that gene testing was likely going to fail. And that they would try to do PDL one, you know, protein testing, which is a different test. It's an IHC test. I read that.

The Patient from Hell (39:48.364)
Oh wow.

Kimary Kulig (39:57.71)
And I immediately got alarmed and I said, we need to order a blood based test, which we haven't talked about yet. And so I put in notes to the, at this point, the patient had only seen a radiation oncologist. He was waiting for an oncology appointment. So I alerted the radiation oncologist and I said, look, we need biomarker testing. It's not, not my department. I don't order it. It's a good idea though, but.

The Patient from Hell (40:12.748)
Oh my god.

Kimary Kulig (40:26.862)
It's not my, you know, he'll have to, his oncologist will have to order that. And so again, put in notes to the, to the staff and you get a call back from an oncology nurse and says, well, it's the oncologist who orders that. And he hasn't seen the oncologist yet. I'm like, I get it. But can we just, can we just, you know, like fast forward this a little bit and can the oncologist please order a blood based test because of this notation.

In the end, we were able to move it up by only three days. The oncologist did do it before he saw the patient, but it took so much time. We only shaved off three days in that case. But there's a perfect case where if the pathologist is writing the notation, there aren't going to be enough cells to do NGS, then boom, they should reflexively murder a blood -based biomarker test in place of.

And that's, I feel that's a perfect example of what needs to happen in the clinic.

The Patient from Hell (41:29.74)
You sound incredibly calm. Just in hearing your story, I am so agitated. Just so you know, I'm at a more suitable temperature. You sound so calm. I just, when I hear stories like this, and I think it's partly because I go through versions of this, except I'm a survivor and I don't have a nine month life expen - well, not that I know of. A life expectancy at this point in time. But what you're describing happens all the time. All the time.

Kimary Kulig (41:57.198)
Mm -hmm.

The Patient from Hell (41:59.724)
So part of me is really, really annoyed at the system. And the other part of me feels horrible for the oncologist because if you look at that days, they're going back to back, they're burnt out. They barely have time to eat, sleep, drink water. They're doing truly, truly life -saving work and they have 20 minutes with patient. So part of me is like super mad at them. And the other part of me is just like, oh my God, I feel so, so sad.

Kimary Kulig (42:28.846)
Yeah. Well, it's sort of that this is the way we do it, right? Like they haven't seen the oncologist yet, so they can't order, you know, and it's kind of like, you know, and very sadly in this particular case, this patient from the time they were, from the time tumors were found in his body until his death was only 44 days. So do the math, okay? A two week, a two week wait is...

The Patient from Hell (42:29.836)
It's just, it's a...

The Patient from Hell (42:52.012)
Oh!

Kimary Kulig (42:58.19)
a significant portion of his remaining life expectancy. Now, nobody knows that walking in the door, they can say, but I think we have enough clinical experience to know a heavily tumor, a heavy metastatic burden, lung cancer, aggressive. I think we need to prioritize these cases. I really do.

And but again, everything you said is true. The system is overwhelmed. Everyone is overwhelmed. I mean, it's, it's difficult. But I do I think I just keep trying to focus on practical solutions. So if practices, practices like that had someone in between someone like me who read that report and said, Hey, this isn't going to work. We got to order this right away.

We could have shaved a couple of weeks off of that for that patient. So that's what I'm trying to demonstrate the need for is that it's not only the patients who need navigation, quite frankly, it's the practices, it's the oncologists themselves, because how can we expect them to keep up with all of this? They're not taught molecular.

The Patient from Hell (44:10.924)
I'll just do it.

Kimary Kulig (44:21.934)
biology and medical school, you know, and unless they went out of their way to get this education or they also did a PhD along with their MD and you know, this is, this is, and it's only going to get worse, right? I mean, it, the, the more we discover about tumor biology and molecular biology of cancer, this is just going to explode. And so we need to get ahead of this. And that's why I'm doing what I'm doing because I really think this is.

It's going to be like the equivalent of genetic counseling. We need somatic mutation counselors, i .e. biomarker navigators, to talk to the patient about this. I've had patients who've come to me because they had no one else who would walk through their biomarker report with them.

You know, 800 gene report is not something that an oncologist has time to sit down and talk to about a patient. Instead, they say, you know, there's nothing actionable in here, you know, or, you know, you wouldn't understand it or I don't even understand half of this stuff. This is what patients are being told by their very own oncologists. And I've had a couple of patients who've called the gene testing companies and said, can you go over this report with me?

And they say, no, you have to talk to your oncologist about it. So it's like this run around, you know, and I find that that's one service I do provide to patients that they're very grateful for because I believe everyone has the right to understand their own biology. And I always start with education. You know, like I want you to understand what this gene is, what's happening with it and why it's important to your treatment.

It's not sort of prescriptive. It's let me help you understand what's going on in your body and why it's important to ask these questions to your doctor. So.

The Patient from Hell (46:25.9)
Kimmy, I'm looking at the clock and I think you and I already prefaced this before the podcast started. You and I could talk about this for hours and hours and hours and we will definitely have to have you come back on the show and have a much broader discussion on the many different aspects of biomarker testing. In a way to sort of conclude our conversation from today.

What is one thing, so in the absence of having many chemurias across the world, which would be great, but in the interim, while that's not maybe an option, what is one thing someone who's going through this, a patient or a family member who may be diagnosed with lung cancer or breast cancer or other kinds of cancers that have biomarker testing as part of the sort of diagnostic or treatment pathway, what is the one thing they might be able to do?

Kimary Kulig (47:17.806)
that they might be able to do.

The Patient from Hell (47:19.788)
to change the course of their outcome.

Kimary Kulig (47:23.118)
Yeah. Yeah, I think the first thing is just to be aware of it as a critical and it's a part of your care that can't be skipped. The first question I always ask a patient is, have you had biomarker testing? And oftentimes the answer is, I don't know, or they don't know how to find it. And part of the problem is it's not often uploaded into your MyChart.

right, or your patient portal.

The Patient from Hell (47:53.836)
We can do a full episode on just that one, by the way. That moment right there. You and I can talk about just that for a full hour.

Kimary Kulig (47:58.254)
So that's the first thing I coach them is like, you know, it's something you have to ask for. You're going to have to ask someone in the office to scan it and upload it in there for you. And so that's one thing is just being aware of that upfront and ask, and if it hasn't been done to ask for it.

And that's where it's kind of like, well, what do I know to ask for? What do I, you know, I don't know anything about this. So how can I ask for something I don't know about? And that's part of the like teaching, teaching patients to, to at least know what they don't know, you know, in some ways, like you don't have to get really deep into this, but you just need to know that this is, there are these markers that have to be tested in order for you to assure yourself that you're getting.

minimally standard of care, yet alone the best option for your care.

The Patient from Hell (49:04.748)
Thank you for that. I think that's a, I'm smiling because it's just such a.

Such an incredible place we end up with the conclusion of the podcast, right? It's incredibly complicated, very sciencey, very biology driven universe that we're living in. If there's one thing you can do is ask your doctor about biomarker testing and two, make sure you get the report. Which is really hard. Oh no, I will not be surprised. Definitely been there. Don't worry.

Kimary Kulig (49:15.406)
you

Kimary Kulig (49:23.79)
Yeah.

Kimary Kulig (49:31.598)
Yeah, it sounds simple, but you'd be surprised. Yeah.

The Patient from Hell (49:39.404)
There is a reason why I can have an hour conversation on genetic reports not being uploaded in the right place in the EMR. Kimri, I have been there so many times. Finding the genetic report from three years ago for me is a nightmare. It takes me about 45 minutes of dating, even today. So I...

Kimary Kulig (49:56.366)
You know, that's one thing I do. I do it on behalf of patients. I say, you know, if you're comfortable, give me a username and password. I'll go in and I'll pull it all down for you and collate it and give you a nice summary back. And it's amazing how helpful that is to a patient, you know, because you're going through, I don't know how patients could possibly manage this. Like I think about as this gets more complex, and again, it's only going to get more and more complex.

How can we expect everyone just to stay on top of this? I think that my underlying message here is we need to bring in a whole new profession into the mix and they need to be scientists, quite honestly. It sort of takes a very special understanding of what the patient needs and what the clinic needs.

The Patient from Hell (50:41.9)
Yeah, correct. I agree with that.

Kimary Kulig (50:55.662)
as support in that respect.

The Patient from Hell (51:00.14)
On that note, Kimri, I am with you. They need to be scientists. And we don't have it today. So I fully, fully understand and fully appreciate all the work you do. And that's one of the reasons I'm such a fan girl. One of the many reasons. Kimri, I really appreciate you taking the time and for teaching us about the world of biomarker testing, why it's important and what you can very practically do today about it as a patient or a family member. So.

Kimary Kulig (51:12.974)
Thank you so much.

The Patient from Hell (51:27.692)
Thank you for coming on this podcast. I'm sure you will be back again and we'll dive even deeper into the topic of biomarket testing. Thank you.

Kimary Kulig (51:30.83)
Thank you.

Kimary Kulig (51:35.022)
Thank you, Samira. It's my pleasure, my honor.