In this episode of The Egg Whisperer Show, I’m joined by Trudy McKanna, Senior Field Medical Director at GRAIL, to talk about a groundbreaking new test called Galleri®. This multi-cancer early detection test can identify signals of more than 50 different types of cancer through a simple blood draw, often before symptoms appear. For anyone focused on protecting their long-term health, identifying possible cancers early, and for those who have done treatment and may be concerned about future cancer risk, this technology could be life-changing.
We talk about how the Galleri® test works, the science behind it, and what this means for cancer treatment and detection. Trudy also shares why early detection is so critical, how accurate the test is, and what healthcare providers and patients need to know about accessing this innovation.
In this episode, we cover:
- What GRAIL’s Galleri® test is and how it works
- How early cancer detection offers more time and options for care, plus how it may help patients avoid chemo
- Why the test could revolutionize preventative care and cancer treatment plans
- What fertility specialists and patients should know about using Galleri® after Clomid usage
- How GRAIL is working to expand access and education around early detection
Resources:
Find Dr. Aimee’s Fertility Essentials & Supplements
Full Transcript:
Dr. Aimee: Welcome to the Egg Whisperer Show. Today we’re going to talk about detecting cancer early, how GRAIL’s technology can help with Trudy McKanna. So, one of the biggest fears my patients have is about their risk of long-term effects from being a fertility patient from all the medications that they take, and in this episode, I talk with Trudy McKanna from GRAIL about how their groundbreaking Galleri test is changing the game in early cancer detection Welcome Trudy. Thank you for joining me.
Trudy McKanna: Thanks for having me.
Dr. Aimee: I’m going to tell you a little bit more about Trudy. She is a Senior Field Medical Director at GRAIL specializing in genetic counseling and medical affairs.
Previously, she spent nine years at Natera leading medical education and clinical initiatives in transplant and renal genetics. She holds a master’s degree in genetic counseling from the University of Michigan, also my alma mater, and has extensive experience in genetic research, education, and patient advocacy. For people who don’t know about GRAIL, tell us a little bit about it and the company’s mission.
Trudy McKanna: Thanks Amy. GRAIL’s mission is to detect cancer early, when it can be cured. So, this is a lofty mission. It’s not something we’re saying we’ve achieved yet, but we’re saying this is something that we think is possible with new technology. We have one product on the market that’s been available for about four years.
It was launched in June 2021 called Galleri. The company was formed in an interesting way from an unexpected discovery in the prenatal space. Our former parent company was offering prenatal genetic screening called non-invasive prenatal testing, or NIPT, which you may be familiar with.
And this is a test where you can draw blood from mom and screen the pregnant woman to see if there are certain genetic conditions in the baby. Doing a hundred thousand plus of these tests, they found about 10 women where they just couldn’t interpret the results. And unfortunately, what they found in those women is either during their pregnancy or soon after delivery, they were diagnosed with cancer and different types of cancer.
And so that was kind of the aha moment when they were looking for one thing, they found something else. And not only did they realize we can find evidence of cancer in the blood before anybody has symptoms, but it wasn’t even related to one type of cancer. It could be multiple different kinds of cancer.
Dr. Aimee: That’s like a dream come true. For a doctor like me, where you want to do everything in your power to give patients knowledge before they even start a pregnancy. And, for patients who’ve done like 6, 7, 9 rounds of IVF. 10 years from now when they’re, let’s say, in their fifties, when they’re wondering, “Huh, I wonder if all those cycles put me at risk for cancer,” then maybe they could be doing this test, and this test can detect over 50 cancers before symptoms appear.
How does the technology work? I mean, you mentioned it’s a blood draw, but how does it work and why is it a game changer for early cancer detection?
Trudy McKanna: Yeah, so I mentioned how the origin story was from non-invasive prenatal testing, and in that screen what you’re looking at is cell-free DNA. So, everybody has cell-free DNA, which is just little pieces of DNA from your cells as they die, and they’re circulating in your blood. If you are pregnant, then the baby was also emitting cell-free DNA, that’s what the NIPT test was doing. But cancer also can have cells that die and emit cell-free DNA into the circulation. And so, this is what we’re looking at when we draw the blood, is we say, “Okay, can we remove everybody else’s cell-free DNA that we’re expecting to see from you?”
But do we also see essentially a fingerprint of cancer DNA? So, cancer cells are cancerous because they can’t stop growing. They’re missing all those normal cell functions to tell it, to stop dividing. And that has a unique fingerprint that we can detect in the body if there’s enough cell-free DNA from a tumor.
In circulation, it really is a game changer because this allows us to screen asymptomatic healthy people for cancer, not a single type, because all different cancers should have that underlying fingerprint.
Dr. Aimee: When someone gets a cancer diagnosis, I mean, that’s scary. And I think what people don’t realize is that most cancers are survivable if you catch them early enough. So, tell us more about that. How does early cancer detection change the trajectory of treatment and survival rate?
Trudy McKanna: Everybody’s very familiar with the, I think, five single cancer screenings that we have available now at certain ages or certain risk factors. So, mammography for breast cancer, colonoscopy for colon cancer, cervical cancer screening with pap smears, and then for certain individuals, low dose CT for lung cancer and prostate screening cancer with PSA.
The idea of screening for single cancers early because we can change the trajectory of that treatment has been around for a long time. Unfortunately, though it’s been limited to those five cancers, which only account for about 30% of all cancer. What about the other 70% that we can’t screen for?
We’re waiting for symptoms to develop or something else to come up. So now we’re able to look for cancers early and studies have shown that the five-year survival rate for early-stage cancer is about 89%. But, and as you mentioned, it goes down as you’re diagnosed, after that cancers had a chance to spread.
That five-year survival rate is about 21%. So, about a fourfold increased survival rate, when you can catch that cancer early.
Dr. Aimee: In general, how much earlier does the GRAIL test allow someone to know they may have cancer? And I’m sure it’s a hard question to answer because it’s just, you never know. I mean, it might take years until someone finally has symptoms from stage three or stage four ovarian cancer.
Trudy McKanna: With a Galleri test, and we call it a multi-cancer early detection test, what exactly does early mean? And early oftentimes may just mean that it’s before symptoms arise. So, before somebody is presenting into the ER with, you know, symptoms that get diagnosed with a late-stage cancer, we want to detect it as early as possible.
And one of the best ways to do that is really integrating this into routine care so that you’re screening all the time. So those more aggressive cancers, those quicker growing cancers don’t have time to kind of sneak up on people.
Dr. Aimee: So, Trudy, for someone who has no science background, what is the Galleri test?
Trudy McKanna: Galleri test is a multi-cancer early detection test, or MCED test. If you break it down into its components that describes exactly what it is. It is a multi-cancer, so it’s screening for several different cancers, which is different from current single cancer screens. This is screening for multiple cancers early and early can be subjective. It’s usually what we’re thinking is it’s earlier than you would normally be diagnosed, so before symptoms develop. And then early detection: so, we are screening for multiple cancers to find them early, as early as possible.
Dr. Aimee: And it’s just a simple blood test.
Trudy McKanna: Just a simple blood test.
Dr. Aimee: I mean, that’s just groundbreaking. It’s mind blowing for me that we’re at that point in medicine that we can have a test like this and I’m just so glad that you’re coming to talk to us about it.
And then how accurate is the test in predicting the origin of a detected cancer? How does that guide the next steps in diagnosis and treatment?
Trudy McKanna: Yeah, that’s a great question and an important part of what multi cancer early detection tests should have as a fundamental piece of their benefit is we don’t want to do a test that just says “We see a potential signal or a potential fingerprint of cancer. Go find it.” It’s kind of scary to get any kind of result like that.
But if there’s no diagnosis path that’s clear, that can also add to that anxiety. What GRAIL does is we are able to narrow down the cancer signal origin or CSO with about 93% accuracy. So, we can say, we did see that fingerprint of cancer in your blood, and it looks like it’s coming from one of these 18 different areas.
So that kind of helps that patient and the provider organize that follow up screening much more efficiently.
Dr. Aimee: Yeah, and this gives patients time to make plans, and it gives them options. There was an article in the Atlanta Journal Constitution. They investigated new genetic sequencing technologies that detect minimal residual disease or MRD in cancer patients, potentially reducing the need for chemotherapy. How does GRAIL’s Galleri tests align with these advancements?
And what implications could this have for fertility preservation in patients who might avoid chemo?
Trudy McKanna: Yeah, so MCED is a prediagnostic test, so patients don’t have cancer yet. MCED can help detect cancer ideally earlier. And then the MRD tests can then take that patient the rest of the way through their cancer journey. Like you said, understanding how the cancer is behaving before surgery, after surgery and onward.
They’re quite different tests, but they really both are brand new tests that work in that cancer care continuum and really have changed the trajectory of a cancer diagnosis. What does that mean? There are so many more tools available. In my mind, the ideal cancer diagnosis path in the future, and hopefully the not-too-distant future, is you use a multi-cancer early detection test. You have a cancer diagnosed earlier where you have much more simple treatment options like surgical resection or something that could avoid chemotherapy. MRD allows the patient and the provider to feel comfortable with where that journey is going, and then after treatment is over at a an appropriate time, restarting the Galleri Test, the MCED test to say, “Let’s not just look for the one cancer that we did find for recurrence, but let’s also remember that there are other cancers that could happen and we want to continue screening for all of those long term as well.”
Dr. Aimee: How often should someone be doing the Galleri Test? I mean, I imagine you do it once, should you do it again five years later, 10 years later? What’s the regular interval that someone should be doing it?
Trudy McKanna: That’s a great question, and when we get asked pretty much every time, we are talking about MCED testing, and it’s a great point to make that the day you draw your blood for an MCED, it’s only looking at, “Do we find that cancer signal in your blood that day?” And so that means that you have to have a cancer that is growing and emitting cell-free DNA into your blood on that blood draw day. And so, we can also have false negatives where it could miss a cancer because it’s still too early. It hasn’t, it’s not, doesn’t have access to the bloodstream yet, or it hasn’t developed yet. So, we did several studies, both modeling studies and real-world data studies, looking at people who had our test over a couple of years and, also another study with American Cancer Society and said the most appropriate time if you want to detect the greatest number of cancers as an annual basis. Because those fastest growing, most aggressive cancers can have a dwell time of under a year. So, you could have a clean bill of health in January of this year, and you know, the worst case scenario is one of those cancers is developing and you want to catch those as early as possible.
Now because it’s not covered by insurance, it could be something where people make a different financial decision but annually is a reasonable cadence and it also works well with just normal annual physical screens that you’re going in, and that’s, I think, ultimately what our goal would be is to have that integrated into annual physicals, this is part of your cancer piece, of your annual screen.
Dr. Aimee: Because cancer is so common. It just makes sense.
I worry about patients who are mine, who’ve, let’s say, come to me after a journey of, 6, 7, 8 IVF cycles, and they still want to do three, four, or five more. And all the hormones they’ve been on, especially in patients who’ve taken a medication called Clomid. So there might be an increased risk of ovarian cancer associated with Clomid.
There was a study published in August of 2024 titled “Fertility Drugs and Cancer,” and it was a nice summary about the risks from these drugs. And so, I feel like fertility doctors need to know about this test, and I think it should be part of our counseling saying. Look like after your journey, maybe in 10 years, start doing the Galleri test on a, I don’t know, maybe on an annual basis or every three to five years, something like that.
But one of the barriers to these kinds of tests is like doctors, we know about the NIPTs, right? So, you know, how do we get more doctors to know about this test?
Trudy McKanna: Well, hopefully things like today’s podcast are one of the things that we can do to help spread the word. What we’re finding a lot is patients are coming to their doctors and maybe it’s their primary care provider, maybe it’s their fertility specialist, someone else to say, “I heard about this test from any number of sources, I’d like to learn more information.” So sometimes, and not rarely, patients are educating their providers. I also have a team of medical science liaisons, so medical professionals across the country, whose entire job is to go out and educate healthcare providers, to tell them about our studies, to tell about the validation.
You know, like you mentioned earlier, it almost sounds too good to be true and understandably that can be a healthcare provider’s first reaction if they haven’t heard of it. But we have the data that we can show to say this is not something that doesn’t have scientific rigor behind it.
You’re aware of NIPT. It’s using the same technology that’s been around for decades. It’s just a new application, a fantastic application and here’s where it is. So, you hit the nail on the head on this test. We want to be able to be in the hands of as many people as possible, and education and awareness is the number one goal to get there.
Dr. Aimee: Yeah, well said. And then, can patients ask for this test now? I mean, I know my patients can, but what if there’s a patient at another clinic? How can they get the test if they want it?
Trudy McKanna: There’s a couple different ways. And, at the end of the day, we recommend that, no matter what your situation is, you talk to your healthcare provider about your risks for cancer. There are certain things like you’ve mentioned with the fertility meds, a personal history or family history of cancer, kind of looking at that holistic person.
Their age at the end of the day because all those things like you mentioned before have an additive effect as you age. Over time, that risk of cancer is going to increase. So, it’s a very personal choice when somebody wants to get tested. It’s also a financial decision right now. Most insurances are not covering it, so it’s something where talking to their, your healthcare provider about your risks, your specific experiences to look at overall, is this test right for you right now, would it be the first step? One of the ways that people can find out more information though is on our website, Galleri.com. There is a patient resource center and a very comprehensive amount of information for patients, and for providers if they wanted to direct their providers to that testing.
Dr. Aimee: Yeah. And what if there’s a patient who’s on the fence and not sure if they want to do the test or not? What would you say to them?
Trudy McKanna: Yeah, that’s a great question. And again, I think it just goes back to personal choice. We have a lot of programs where it’s covered by, say, an employer and you’ll hear people you know very differently say, “Oh, I want to know as soon as possible,” and other people who don’t want to know.
And so, it’s something that nobody can make the decision for you. You must just look at what are the risks and what are the benefits? And one of the things that we do consider in screening younger patients is that all screening tests like this have false positives. They’re not a diagnostic test, it can come back and say, we saw a fingerprint for cancer and a workup does not find cancer. So, we want to weigh the risks of the anxiety of that and the workups that would follow to do that, versus the absolute risk for cancer. And everybody must make their own choice on that.
Dr. Aimee: Yeah. And what about someone who feels healthy and has no symptoms? Is this a test that could help them?
Trudy McKanna: That’s really our target population. Again, people who are at an increased risk of cancer, such as those age 50 and older but could have other risk factors who are asymptomatic, who before were waiting for those symptoms or those non-specific symptoms that we are catching this as part of routine screening.
Dr. Aimee: And I just want to make it clear that my podcast, nothing on my show, is ever sponsored. So, no companies reach out to me to say, “Hey, we want to plug this product.”
You know, I find people that I think are going to change the world and make this world a better, healthier place. And that’s why I reached out to Galleri, and I said, “I need to learn more about your test. I want to talk to you. I want to have patients who are curious about whether this could be for them to find out more.” Trudy, is there anything else you’d like to add today?
Trudy McKanna: I think at the end of the day, everyone has a story about cancer, either a personal story, family history, friends affected, so this is something that really does have the potential to change everyone’s lives, whether it’s your own diagnosis of cancer or a loved one. And so, thank you today for the opportunity to explore this new development of multi-cancer early detection, and to increase that awareness so that we can continue to have that impact on the public.
