Uncovering Early Cancer Detection with Stephen Hahn, Chief Executive Officer at Harbinger Health

[00:00:00] Hey everybody, Saul Marquez with the Health Matters podcast. I want to welcome you back

[00:00:13] to another episode and today we are here with Dr. Steve Hahn, Chief Executive Officer at

[00:00:20] Harbinger. He is the CEO, partner of Flagship Pioneering and also Chief Executive Officer

[00:00:27] at Harbinger Health. Steve joined Flagship in June of 2021 as Chief Medical Officer of its

[00:00:33] preemptive health and medicine initiative, which is creating a new field that aims to protect,

[00:00:38] maintain and improve people's health before they get sick. Such a pleasure to have you here,

[00:00:43] Steve, and excited to dig in. Yeah, really appreciate it, Saul. Absolutely. Thanks for having me.

[00:00:47] Yeah, it's my pleasure. And look, before we dive into the work that you guys are doing at

[00:00:50] Harbinger, tell us a little bit more about what inspires your work. One of the things and

[00:00:56] the reason that I joined Flagship Pioneering after I was at the FDA was because of the fact that

[00:01:03] we have major problems across the globe in terms of chronic disease. And Flagship was committed

[00:01:09] and Harbinger is one of those companies to finding disease early before people have symptoms,

[00:01:14] before it becomes a problem, before you can't take care of it. And so to me,

[00:01:18] that was so impactful. And I was looking for something significantly impactful to work on.

[00:01:23] The other thing that's really important to me is the access issue. If we didn't learn from COVID,

[00:01:27] that way of issues people accessing care, trust in the healthcare environment, trust in companies,

[00:01:33] trust in new therapies, vaccines, etc., then we're never going to learn the lesson. And to me,

[00:01:37] I wanted to work with a company, with a group, but it was really committed to making sure

[00:01:41] that this was the things that were developing, the therapies, the diagnostics, etc., accessible

[00:01:47] That's great. Sounds like it's very much aligned to your personal mission and one that gives access

[00:01:53] and early detection to all. Detecting cancer early using a blood test sounds like a really good

[00:02:00] idea. What are some of the challenges today that make that harder to do than it sounds?

[00:02:05] And what are some of the possibilities you see if we can find ways to do it better?

[00:02:09] Yeah, you bet. And I'm going to use cancer as an example, but this could be for

[00:02:13] Alzheimer's, Parkinson's, a lot of diseases, but parmigial health is focused on cancer.

[00:02:19] And so the first big problem with cancer screening is identifying early stage cancer. I was a lung

[00:02:26] cancer doctor. We did pretty well at identifying stage three and four, so advanced stage cancers

[00:02:31] where it's difficult to treat and where also it's more toxic for patients. We need to do

[00:02:36] is diagnose patients earlier. So one of the big things we're focused on is how do our biological

[00:02:42] markers, the blood tests we're drawing, how does that allow us to identify people with early stage

[00:02:47] disease? So important, so impactful for folks because at the end of the day, that's how you're

[00:02:52] going to cure more people with cancer. The second big thing is what I'm referred to as clinical

[00:02:57] informativeness. You go to the doctor, you get a blood test, you want your doctor to know

[00:03:01] what to do with that blood test, right? It does not help you get a blood test and the

[00:03:05] doctor says, what do I do now? And one of the problems in this sphere of blood based

[00:03:09] cancer screening is in fact, now what do I do with the information? Part of that is,

[00:03:15] is this a cancer that needs to be treated or should be watched because that's true in cancer and will

[00:03:20] be true of other diseases. But the other big one, is there actually a cancer present when the

[00:03:25] blood test says, I'm worried that there might be a cancer present? We refer to that as positive

[00:03:30] predictive value. It's a little technical, but the point is you want your doctor to say,

[00:03:34] if that's a yes test, it's pretty much real that it's a yes. And now I can do some scans

[00:03:39] in a biopsy. If that's low, you're sending a lot of people for scans, etc., that don't need them.

[00:03:45] And then the last part is the whole access issue. And what's really important about the access is

[00:03:50] so many people have fallen behind in cancer screening. So many people aren't getting their

[00:03:54] mammograms, CT scans, blood tests, pap smears, etc., the standard of care screening that

[00:04:00] saves lives. We know it does. And how can we make sure that what we're developing

[00:04:05] is inexpensive and accessible in a decentralized way and something that people are going to trust?

[00:04:12] All of those things go into access in their top of mind for Harbinger Health.

[00:04:16] That's fantastic. Really, a great summary there, Steve. And it's about access. It's about being

[00:04:23] able to trust the test. So getting rid of those false positives. And then ultimately making it

[00:04:29] easy for everybody. Making it easy. We all go to the doctor. You might not. But a lot of us

[00:04:35] once a year. Some of us will get routine blood work, right? Cholesterol screening, etc.

[00:04:40] That's a really good thing because if you identified it early, you can treat it

[00:04:44] and it prevents heart disease. We want that same thing to be for cancer.

[00:04:49] Regular blood tests, inexpensive. Heck, have someone go to your home and draw your blood

[00:04:54] as opposed to come into the doctor. Really make access pretty easy.

[00:04:58] And making it possibly even part of a normal panel.

[00:05:02] Exactly. Like a cholesterol, yeah, kidney function, etc. It's exactly our vision for

[00:05:06] the future. That's where cancer screening has to go. And by the way, if you could do that and

[00:05:10] really make it a decentralized test, you could go to parts in the world where there's even

[00:05:15] less care than some of the places in the United States such as rural America.

[00:05:19] You could really make this a decentralized point of care approach. Now that's

[00:05:23] 10 years from now, but that's where we're heading. I love that. It's promising

[00:05:27] and really great to know that the future possibilities with what you guys are doing

[00:05:31] are so well aligned to a better and healthier future for a lot of Americans.

[00:05:36] How does Harbinger's technology work? How might a patient or physician interact with

[00:05:41] the Harbinger blood test when you roll out your first product?

[00:05:44] Yeah, for sure. The basis of our blood test, we draw blood from a person.

[00:05:49] And what we're looking for is a specific signature in a person's DNA.

[00:05:54] So we're looking for circulating tumor DNA. We know that cancers when they're present shed DNA

[00:06:00] into the blood, we're looking for that. That's the genetic material of the tumor.

[00:06:05] And then we're looking for a specific signature. This brings together, that's why I'm so excited

[00:06:09] about it, brings so many things together that we've known about cancer for years

[00:06:13] and we know where to look. It makes it easy because that circulating tumor DNA in the

[00:06:18] blood is like a needle in a haystack. But we have technological approaches using machine

[00:06:23] learning and AI, but also laboratory approaches that allow us to get some of that hay out of the way

[00:06:29] so that we can find the needle in the haystack. So what we would envision is an inexpensive,

[00:06:35] almost point-of-care test just like a cholesterol screening. Get it as part of your yearly exam

[00:06:41] that would allow us to detect potentially the presence of 10, 20, 30 cancers. And then at

[00:06:49] that point allow the doctor to have information that directs them. What should they do next?

[00:06:54] Now we have a multi-tier approach. It's very common in medicine. Think of mammogram. A woman goes in

[00:07:00] for a mammogram, she gets a screening mammogram. We don't tell her she has breast cancer. We tell

[00:07:05] her she needs, we see something abnormal, but it might not be a cancer. Come back and get

[00:07:09] an ultrasound, another x-ray, etc. And then only then do we tell her that she might need a

[00:07:14] biopsy. Same thing is going to happen with our tests. Initial and expensive screening,

[00:07:18] if it's negative go home, come back next year. If it's not, come back and get a second test.

[00:07:23] We want to verify that there might be a problem here. If there is, we can then tell the doctor

[00:07:28] this is what you do next. And that gives a great deal of comfort we think to providers and to

[00:07:33] patients that were on the dry track. And it also addresses this issue of positive predictive

[00:07:38] value because we want our yes to be a real yes. That's fantastic. Thank you. Thank you for that,

[00:07:44] Steve. And really taking a look at cancer screening tools so far, they've been fairly limited in their

[00:07:50] use. How has Harbinger tackling the problem of access? Why is that important to you?

[00:07:56] So there's two issues there. One is there's only five cancers in the United States and

[00:07:59] there's less across the world that actually have standard of care screening. Colonoscopy

[00:08:04] for colon cancer would be one of them. It's limited in terms of the number of cancers where

[00:08:09] there actually is a proven test that improves survival for cancers and improves outcome for

[00:08:14] patients. So that's one issue. And that's where the multi-cancer blood test helps because if indeed

[00:08:20] we can show through clinical studies that it does benefit patients, people, then there's a broader

[00:08:26] number of cancers that we can potentially attack and screen early. The other part of access

[00:08:31] is do you want to come in for your mammogram CT scanner colonoscopy? And we see uptake of colonoscopy

[00:08:39] around the United States pretty low. It's in the 30% range of people who are eligible for it.

[00:08:43] That's a problem. And how easy is it for someone to get a screening blood test? We're all pretty

[00:08:49] much going to get our cholesterol. Some of us are getting hemoglobin A1c to look for diabetes.

[00:08:53] That's happening across the country even in rural and underserved communities that's happening.

[00:08:58] Far vision is one way to get to folks, make it inexpensive, make it easy, make it so that their

[00:09:04] doctors can easily order that test and get done around the corner and then have those results

[00:09:10] relatively quickly available to the physician to make some decision making.

[00:09:14] Yeah, Steve, and you think about cost in the system. A lot of the runaway cost comes from

[00:09:20] these types of surprises that come too late. As payers consider this type of technology,

[00:09:27] I think when you look at the numbers, they probably make sense or they should make sense

[00:09:31] economically. They should make sense economically. And this is where particularly in cancer,

[00:09:35] what's better for people and patients is better from a health economic point of view.

[00:09:40] Think about cancer. If you get diagnosed with stage three and four cancers and there's late

[00:09:45] cancer, late stage cancers, hard to cure those folks and a lot more expensive. In fact,

[00:09:50] if you look at breast cancer, it's about six times more expensive to treat someone with

[00:09:55] stage three and four disease than one and two. Now, that's not the primary concern of a cancer

[00:09:59] doc. Cancer doc is I want to get them treated early because I can cure them, right? But there

[00:10:03] is this alignment that you say. So let's screen people. Let's get the cancers identified at

[00:10:08] early stage. That'll save more lives, but it'll also save more money so that we can spend it

[00:10:13] on other innovations that help people with problems that need to be addressed.

[00:10:17] That's really great, Steve. And there's got to be a crawl walk run to this, right? Maybe

[00:10:22] it's concierge medicine that you start with or then you tackle Medicare Advantage. I think there's

[00:10:29] promise here. There is definitely promise. I'm going to rebel a little bit, not because they don't

[00:10:34] concierge docs, but because it doesn't address the access issue. It's why we're so focused on cost

[00:10:40] of the test. Let's make it inexpensive enough that folks can pay out of pocket sometimes. But

[00:10:46] even let's talk about how we could work with a Medicaid and a Medicare, etc., to get this

[00:10:50] done in a way that's cost-effective for them. Because at the end of the day, they want to save

[00:10:55] their covered live, the people who are on their insurance, but they also don't want to break the

[00:11:00] bank. And that's where we've got a problem. And that's where I think the crawling and then

[00:11:05] the walking makes sense and then the running. Steve, thanks for doubling down on that. It is

[00:11:09] clear that access is a primary part of the mission and really grateful for you to highlight

[00:11:14] that here today. Look, for everybody listening, what would you give them as a call to action?

[00:11:20] I think the call to action is to let's come together and build trust. It's the one thing that

[00:11:25] I'm the most worried about, the commercialization, the insurance coverage, all those things will come

[00:11:30] with time as you say, crawl, walk, run. It'll happen. And I feel strongly that the data

[00:11:37] will be there to allow that to occur. It's going to happen too slowly because I'm an impatient

[00:11:41] cancer doc who wants to see his patients get treated earlier and better. But a prerequisite

[00:11:48] for all of this is building trust. One thing I learned when I was FDA commissioner during COVID

[00:11:53] is that we've lost a lot of trust and not just over COVID, but over a lot of things. And those

[00:11:59] folks who have the least access and are the ones who don't have a regular doctor they go to or

[00:12:07] insurance, all the issues related to access, those are the folks who trust us the least.

[00:12:13] And what I would say is let's start the conversation now. Before I'm asking you and saying,

[00:12:18] I'm selling you a test that I want you to come get every year, let's have a conversation now

[00:12:22] about why that's important and how you can help us achieve that dream. Because at the end of the

[00:12:26] day, I want to look across from the grandma in East Texas and say, I want your grandchild

[00:12:32] to have a test that keeps them from getting a cancer that can't be cured.

[00:12:36] That's what I want. I'm pretty sure that'll resonate no matter where you're from,

[00:12:40] that'll resonate with folks. Love that Steve. Thanks for closing out with that call to action

[00:12:45] for everybody. The future is bright with leaders like you at the helm on promising technologies

[00:12:50] like these, so really appreciate you spending time with us. You bet, Saul. Thank you.