Tests to Catch Cancer Early

This really has the potential to democratize cancer screening.  Welcome to the Patients Rising podcast.  I'm Bob Goldberg.

I'm podcasting solo while my co-host Terry Wilcox, who's the CEO of Patients Rising, is out this week.  I want to wish everybody a happy Passover and a happy Easter.  And we have a new episode for you today.

Some past shows we've talked about how early cancer screenings can lead to better outcomes.  But what about the cancers that don't have a traditional screening?  For breast cancer, there's mammograms.

For colorectal, there's colonoscopies.  For the other cancers without routine screenings, many patients may go undiagnosed until they progress to the later stages of disease.  And in fact, only 14% of cancers in the country are detected through a regular screening.

So to fix this problem, the health care company, Grail, has created a new way to screen for multiple cancers using a simple blood test.  It can detect over 50 cancers, and 45 of those cancers do not currently have any recommended screenings.  So, you know, as I said before, only one in seven cancer diagnoses is detected through routine traditional screenings.

And I found that astounding and really highlights the need to create more comprehensive screenings so that we can catch and then treat these cancers earlier.  To explain how Grail's cancer screening technology fills this gap, I spoke with their chief medical officer and oncologist, Dr.  Jeffrey Venstrom.

And here's our conversation withDr.  Jeffrey Venstrom, Chief Medical Officer, Grail Cancer Center, United States

So just quickly, we do test for multiple cancers.  And I can get into the types of cancer that we test for.

But I just want to start by sharing your astonishment at the current standard of care, the status of cancer screening, where people think that, you know, we have great screening options for cancer because they've heard of colonoscopies or they've gone in for a colonoscopy or a fit test or, you know, mammograms for breast cancer, pap smears.  But at the end of the day, there are hundreds of different types of cancer and only five available standard of care screening tests currently available.  I mean, importantly, those standard of care screening tests are for individual cancers.

So we've never in the practice of medicine, and this is another reason why I'm at this company too, it's very rare in your career when you can be part of such a huge paradigm shift in both population health, medicine and oncology as an oncologist.  And there's never been in the history of medicine, an ability to screen and detect early cancer multiple times with a single blood draw.  And so that's the big idea.

That's the new innovation with the gallery test developed at Braille is it can detect multiple cancers at once with a simple blood draw.  So, Dr.  Bencham, tell us a little bit about how the gallery multi-cancer test works.

So the gallery test uses next generation sequencing and machine learning algorithms to analyze fragments of DNA in the blood to pick out that needle in a haystack or the abnormal DNA patterns that are associated with cancer and provide a report, a simple report that we provide back to the ordering providers that describes two things.  One, whether or not there is a signal for cancer.  And again, this can be multiple cancers.

We've identified more than 50 types of cancer that this abnormal DNA fragment in the blood can detect.  And that second level of information uses a methylation patterns or abnormalities attached to the DNA to identify the potential tissue of origin of that cancer signal, which again is a really important feature of this task is not only are we providing information back to the provider around whether or not a signal for cancer is detected, but also where potentially that signal is coming from.  For instance, if it's coming from the colon, it might make sense to actually do a colonoscopy instead of whole body imaging.

If it's coming from the lung, it probably makes sense to do a chest CT or a CAT scan of the lung instead of doing a colonoscopy, for instance.  So we provide two levels of information based upon abnormal fragments of DNA in the blood.  Once the blood test is collected, where does it go to get analyzed?

Yeah, so once the blood is collected, it's shipped to one of our labs, most likely the lab in North Carolina.  It's put on one of our sequencing machines and we deliver the results within about 10 to 14 days and a simple report to the ordering provider.  Remember, it's a prescription only test, so you need to actually have a prescription and it's best done in the context of a conversation with your primary care doc to understand that this is not replacing mammogram or colonoscopy.

So making sure that an individual is up to date on those other standard of care screening tests and then it's ordered by the provider.  The test results come back to the provider and actually one of our medical teams, we have a large medical science liaison team here at Grail, will call the ordering provider within 24 to 48 hours to help answer any questions or help them navigate potentially next steps after they get a positive result.  For those that have a positive test, which again is around 1 to 1.

4%, one of our medical staff will call that ordering provider to help them with the next steps.  If cancer is detected early, how can that early diagnosis change a patient's outcome?  We've demonstrated in a Pathfinder study, one of the studies that we read out, a really pivotal study for this field really, this multi-cancer early detection field that we're establishing, came out last year in September and we were able to demonstrate again the ability to detect multiple different types of cancer with a single blood draw and demonstrate the positive predictive value again being around 40% and the ability to catch cancers early about 50% of the cancers that we detected in that study were stage one or stage two or early.

And that's important for your patient audience because the survival rates when cancer is diagnosed early are remarkably higher than when they're diagnosed late stage and metastatic.  And today, most of the cancer is still diagnosed late stage.  So it's around 89% survival rate when a cancer is diagnosed early.

You know, as an oncologist, the conversation is very different when an individual patient comes in with a new diagnosis of cancer if it's stage one, stage two.  You talk about curative intent therapy versus someone coming in with metastatic by and large, survival rates around, you know, 15 to 20% if it's late stage and the conversation is not usually around curative intent, it's usually around palliation and prolonging life while maintaining quality of life.  And so again, it's a very different conversation with a patient and it's a very different survival impact.

So survival rates are dramatically higher when cancers are diagnosed early.  And if you're able to diagnose these cancers early, does it open up more treatment options for the doctors and the patients?  Absolutely.

Yeah.  And so the curative intent type of treatments that are applied when patients are diagnosed with early cancers are just completely different.  It's usually talking about surgery or radiation and not necessarily about, you know, harsh chemotherapy or targeted therapies.

You know, there's a lot of interest too of, you know, now that we are catching cancers earlier with these type of tests, getting the drugs that are in development to earlier cancer patients too.  So demonstrating the effect of these drugs that are oftentimes approved initially in the metastatic or late stage setting for early, potentially neoadjuvant or giving it before surgery.  And so the whole treatment paradigm is changing now that we're catching so many cancers earlier with these type of tests.

Looking through some of the research, I found it pretty remarkable that you were able to find some patients with pancreatic cancer in earlier stages.  Typically, those cancers are diagnosed in the later stages.  And as an oncologist yourselves, I'm sure you've never heard of something so groundbreaking like that until the screening came about.

Exactly.  Again, yeah, there's no standard of care screening for pancreatic or bladder cancer.  You know, I was called by a patient last week who used our test, was completely asymptomatic, went in to her primary care doctor, got this blood draw, had the test, find actually cholangiocarcinoma, which is a pretty rare gallbladder cancer.

So this signal was able to detect an abnormal pattern that's consistent with cholangiocarcinoma.  And she went in for curative intent surgery, had it removed.  Ultimately, it was four centimeters.

Again, completely asymptomatic.  But you don't see these type of cases.  You don't see these patients presenting with such early stage, you know, rare cancers that are detected with a blood test.

It's a completely new paradigm shift.  In oncology, in primary care medicine, and for population health.  So one of the other uses of this test that we haven't touched on yet is detecting secondary cancers, cancers that might occur after your first diagnosis.

And I've spoken with people who've survived cancer, breast cancer, for instance, and they love to get this test because they know they could be at risk for those other cancers.  Exactly.  Yeah.

And as an oncologist, like that's one of the most exciting applications of this test too, is for instance, in a smoker, individuals that have a history of smoking, have one current standard of care screening test attributable or, you know, tied to essentially that smoking history, which is a low dose CT scan.  And we know that the screening of low dose CT scans is abysmal, that the uptake of that was very, very low in the United States.  And for many reasons, probably.

But we also know that smokers are at risk for bladder cancer, for head and neck cancers, for multiple different types of cancer.  And so being able to have a single blood draw that tests for multiple cancers in high risk individuals, same thing if you have a BRCA alteration, for instance, or you have a germline, a genetic or hereditary syndrome of cancers, being able to apply that in this population will also completely change the paradigm of cancer screening for those individuals.  So among individuals who have already received treatment, like an individual who have gone through a cancer patient who's gone through therapy for breast cancer, they're at risk for developing secondary malignancies, they're at risk for developing a recurrence of the breast cancer.

And so the opportunity to apply this test among individuals who are survivors of cancer is also going to be a huge new paradigm shift for oncologists and for the field of survivorship care.  The other big question when it comes to these new innovations is how do we pay for it?  How are payers responding to the test and are they interested in using and reimbursing it?

Yeah, well, look, we have so much interest.  We have more than 30 different health systems partnering with us to implement this test in clinical practice.  We have actually a lot of employers that are now paying for this test for employees that see again the potential, see this paradigm shift in cancer screening and care about their employees.

And so they're offering it as a benefit of being employed at specific companies.  But a lot of employers appreciate that currently, by and large, it's not covered by health insurance.  It's $949 prescription only test available by essentially any licensed physician in the United States.

And we're currently working very closely with payers to try and understand what additional evidence they will need to demonstrate the performance of all these clinical trials that we're running.  Again, 300,000 participants.  As soon as we get data, we're showing it to payers.

We're showing it to health authorities to really get this test ultimately reimbursed because that's what's needed and ultimately.  One of the challenges that many patients in our community experience is simply getting to the doctor's appointments to get their screenings.  And especially in rural settings, transportation is a big problem.

So how can this screening reach those patients?  By design, again, it's a simple blood test.  It's designed to really help democratize cancer screening.

So you can send a phlebotomist to a rural section of a state or we're sending mobile units to rural sections of the United Kingdom to get patients tested, to get individuals tested so they don't have to come into a tertiary care hospital center, for instance, or an academic medical center.  So by design, it's a simple blood test.  This really has the potential to democratize cancer screening.

Thank you to Dr.  Vinstrom for joining the show today.  And thank you for tuning in.

Make sure to click the follow button so you stay up to date with our new episodes.  And don't forget to pass this episode along to fellow patient advocates.  Terry will be back with me on Monday for our next episode.

So stay tuned.  Until then, for the entire team at Patients Rising, I'm Bob Goldberg.  Stay healthy.