With every new client, I do a comprehensive blood test and I am commonly asked if the test will also screen them for cancer.
Until now, I’ve had to explain that although basic blood testing is used as a tool when someone is undergoing cancer treatment, it unfortunately isn’t yet a tool to detect most cancers.
Cancer is among the leading causes of death worldwide. Currently, in the US, 1 in 3 people will be diagnosed with cancer in their lifetime. Of the more than 100 different types of cancer, we currently have screening tests for only 5: cervical, breast, colon, lung, and prostate. And unscreened cancers represent 71% of cancer deaths.
So, you can imagine how eager I am to share with you the important news that there is now a blood test that is an effective screening tool for the most common types of cancer.
Created by a company called GRAIL, the Galleri test currently screens for 50 common cancers. This is such exciting news that I reached out to GRAIL’s Cody Renner for an interview.
He very graciously accepted, and below you’ll find his answers to all my questions.
[Dr. Alexis] What is the name of the test, where was it developed, and where is it currently offered?
[Cody] The test is the Galleri test (https://www.galleri.com/). The company is GRAIL BioTech, which is in Menlo Park, CA. The development of the test was done primarily at GRAIL, but in partnership with a lot of research partners across the US. The test is now offered commercially across the entire US.
Note on worldwide test release dates:
The company Illumina has plans to launch GRAIL’S cancer detection test throughout Africa and Asia, release date currently unknown – read here.
The United Kingdom’s (UK) National Health Service (NHS) is currently running a large study and plans to make the Galleri test available to UK patients, release date currently unknown – read here.
[Dr. Alexis] How many types of cancer and which ones specifically does this test screen you for? How were these decided upon?
[Cody] Galleri covers 50 types of cancer currently. I point out “currently” as the testing will expand to more cancers as we get more data in. This set of 50 are the cancers we are currently clinically validated for, and you can see a full list here.
The cancers currently available are the first types included in the test because while we were looking for all cancers, certain cancer types tend to shed more cell-free DNA (more on that below), making them easier to find.
However, once we found this group we did focus on a subset of the most deadly cancers when honing the test for effectiveness. These are:
- Head and Neck
- Liver/Bile Duct
- Plasma Cell Neoplasm
These were chosen for a few reasons. They are responsible for 76.3% of cancer deaths in the US, most do not have any screening method available currently, and most fall under the category of ‘silent killers’, meaning they don’t usually show symptoms until very late stages.
[Dr. Alexis] What is GRAIL trying to achieve by creating this test? What do they hope to change about cancer diagnosis and prognosis?
[Cody] The goal is to detect cancer early when it can be cured. We are attempting to achieve a ‘stage shift’ — catching cancers in earlier stages before distant metastasis.
Currently, the vast majority of cancers are discovered in later stages and survival rates drop with each progressive stage and drop precipitously once there is distant metastasis. By catching cancers in earlier stages, we increase survival rates, and at these early stages, there are also far less detrimental treatment options available and far more of them.
[Dr. Alexis] What percentage of people, from the total cancer deaths, die each year due to late-stage cancer diagnosis?
[Cody] I’ll give a couple of stats here. 18% of annual diagnoses are stage 4 and that accounts for 45% of cancer-related deaths over the standard 5-year survival curve.
Also, across all cancer types averaged, the survival rate is 89% over 5 years with an early-stage diagnosis, versus 21% with a late-stage diagnosis.
[Dr. Alexis] What are the differences in survival rates with early and late-stage cancer diagnoses?
[Cody] This varies widely by cancer type, but if you average all cancers the survival rate at early stages is 89% as opposed to 21% for late-stage with metastases. For perspective though, Lung Cancer is 56% early and 5% late.
[Dr. Alexis] In very basic terms, how does this test work?
[Cody] All cells grow, divide and eventually die, at which point their contents — including DNA — release into the bloodstream. So at any given moment, there are millions of strands of ‘cell-free DNA’ in your blood, from both healthy cells and cancerous cells.
We have developed the ability to recognize the difference between those healthy DNA strands and ones that came from cancerous cells. We then use the methylation patterns on that DNA to determine the ‘signal of origin’ — where, in the body, the cancer cell came from.
[Dr. Alexis] Is this test the same as looking for genetic mutations to determine if you have any increased risk for certain types of cancer? If not, how is this different?
[Cody] This test is entirely different. However, people with a positive hereditary cancer test (or people qualified as high-risk even without a hereditary test) are prime candidates to utilize the Galleri screen to monitor themselves.
A hereditary cancer test, or genetic mutation test, is intended to show you what your risk level is across your lifetime so that you can make choices about how to best handle your healthcare over the long term. But a hereditary test cannot tell you if you have cancer now.
The Galleri test is a screen for what is going on in your body right now. It is most akin to a mammogram or colonoscopy, but it is a blood draw and screens for 50 cancers at once. The primary benefit is that many of these cancers do not show symptoms until it is too late for effective treatment, so by checking for them regularly we can catch them earlier, which increases survival rates and gives us more treatment options.
[Dr. Alexis] Can you explain the basic process for getting the blood test?
[Cody] It is a simple blood draw. We are contracted with Quest and Any Lab Test Now. Dr. Alexis will have your kit sent to you and then you schedule your blood draw with your local location. It is a 10-12 day turnaround time, and the results come back to Dr. Alexis who will review them with you.
[Dr. Alexis] Does it require a physician’s order and if so, why?
[Cody] Yes. The primary reason is that these are sensitive results that can carry a lot of weight in your life. There is a potential need for a diagnostic workup afterward, which would also require a physician’s order, so it just simplifies the process.
The vast majority of results will be negative and serve as a reassurance to a worried patient that they are free and clear of the cancers we can detect, just as an annual mammogram would. However, if the test returns a positive result, the patient and provider will want to start discussing what comes next.
[Dr. Alexis] What are the possible results of the test?
[Cody] The results of this test are very easy to interpret. You will either see “cancer signal not detected” or “cancer signal detected”.
[Dr. Alexis] What does it mean if you get a result that says “cancer signal not detected”?
[Cody] This means that we did not receive a signal for the 50 cancers that we can currently detect. However, there are cancers we cannot detect, and some indolent (slow-moving) cancers can be missed, as they have much lower sensitivity than more aggressive cancers. These cancers are not the primary focus though and typically move slowly enough to catch it on the next round of testing.
[Dr. Alexis] What are the next steps if you get a result that says “cancer signal detected”?
[Cody] If you get a positive result, you would partner with your physician to order a diagnostic workup to confirm the findings. Then you will be able to start making decisions on what treatment options are appropriate and to determine a course of action with your doctor.
[Dr. Alexis] How accurate is this test?
[Cody] Getting a positive test result when you do not have cancer is very low. The test has a 0.5% false-positive rate. There is a slightly higher rate of a false negative (when you do have cancer but the test doesn’t show it), but this is completely dependent upon the cancer type.
As stated before, the slower-moving indolent cancers shed less DNA and are therefore more frequently missed. However, the most deadly and aggressive cancers have a 76.3% sensitivity average, which is very good.
[Dr. Alexis] Is GRAIL currently collecting data from the blood test samples to use for research or any other purpose?
[Cody] Yes. We have multiple research sites and clinical trials currently running, and any patient who gets a Galleri test has the option of opting in to further research. This is not required though.
[Dr. Alexis] Who is this test most useful for and how often do you recommend that someone do this test?
[Cody] The test has many use cases, but the primary candidates are those patients who are asymptomatic but at high risk for cancer. High risk can mean:
- Over the age of 50
- Family history
- Hereditary mutation
- Heavy environmental exposure, and several other categories.
A great example of “heavy environmental exposure” is a program that is currently beginning with the Firefighters Union here in the US. Due to the nature of their work, firefighters and first responders are exposed to many carcinogenic materials that can increase their risk for cancer and other health problems.
We recommend people in high-risk categories take the test annually with a physical. This is because we are screening for so many different types of cancer, all of which move at very different speeds. While some may move slowly and only need a test once every few years, others move so quickly you may want to test every few months if cost is not a factor. However, since cost often is a factor and we don’t want to overscreen for many of the cancers, we meet in the middle with the annual recommendation.
[Dr. Alexis] Can you do the test if you currently have cancer or have had cancer in the past?
[Cody] This test is not intended for people that currently have cancer but it can be used in certain scenarios. This would be a case-by-case discussion with your physician.
Those who have had cancer in the past are another high-risk group who are prime candidates for monitoring with Galleri.
[Dr. Alexis] What is the cost and is it covered by insurance?
[Cody] The cost for the test is $949 and it is not currently covered by insurance, primarily because the test is still so new. We received breakthrough designation by the FDA and currently have legislation on the floor of congress for CMS (Center for Medicare and Medicaid Services) coverage.
Once this goes through, all major insurers will follow suit to include it in their coverage. Some may come on board before that. However, this could take a month or it could take more than a year. Unfortunately, we don’t know when coverage will become widespread. But in the meantime, cancer is still occurring and concerned patients deserve the option to decide if they want it now.
[Dr. Alexis] What is GRAIL’s backstory? How did it get started?
[Cody] GRAIL has been around for about 7 years and has been entirely focused on research and development up to this point.
The company was a spin-off from another company that has since been acquired, called Verinata. The technology is an adaptation of another test that has been on the market for about a decade and is now ubiquitous for expecting mothers. Non-invasive prenatal testing utilizes cell-free DNA to find little bits of fetal DNA in the mother’s bloodstream and analyzes that DNA for things like Down Syndrome without invasive procedures that are dangerous for mother and baby.
In the early days of that testing, the scientist who developed the test stumbled upon “strange-looking” DNA strands that turned out to be cancerous DNA. At that point, GRAIL was spun off and started down the road of developing this accidental finding into something valuable.
[Dr. Alexis] Can you explain more about the methods used to develop this test? Is this technology something that other countries will be able to use?
[Cody] The test is based on cell-free DNA. Our patents and ‘secret sauce’, so to speak, lie in the methylation assay. This will be available commercially worldwide in the future, but there are many factors at play there — obviously, we want it launched around the globe as soon as possible, but there are many hoops to jump through in order to achieve that.
We have recently launched a major clinical study with 140,000 patients to observe performance at a population scale with the NHS in the UK. You can read the details of that study here.
[Dr. Alexis] What studies have been done and what did they conclude?
[Cody] We have multiple studies, some completed and some ongoing. The primary study used for our clinical validation was the CCGA study. There are also the Pathfinder, Summit, and Strive studies along with the new NHS study. You can see all the studies here on the GRAIL website.
[Dr. Alexis] Has the medical community been welcoming to this new technology? What has been the biggest roadblock or criticism so far?
[Cody] Yes, they have been very welcoming. The primary hesitations have been the price, and concerns from primary care physicians about how to proceed with treatment for cancers they are unfamiliar with.
To address cost concerns, we offer interest-free payment plans, have FSA and HSA availability, and there are a lot of coverage programs in the works.
As for the next treatment steps, we have built a great support system to assist primary care physicians to determine exactly what to do next. We do this through our internal medical affairs team and third-party contracted oncologists, who provide peer-to-peer consults with the ordering physicians.
[Dr. Alexis] Are there any other companies with the same or similar technology?
[Cody] Guardant and Exact Sciences have been working on this technology for nearly as long as GRAIL, but have not been able to achieve clinical validation yet. As of this moment, GRAIL is the only company with a viable commercial test. This will no doubt not be the case in a couple of years, but for the moment we get to enjoy being the first to market.
[Dr. Alexis] Where does GRAIL hope to go with this tech and testing in the future?
[Cody] We hope to implement this testing worldwide and implement it fully to reduce late-stage cancer diagnosis for everyone. With scale and growth in any technology, cost always comes down. We want this test to be available for everyone as soon as possible. With a little luck, we will be able to have CMS coverage in short order and begin further expansion to reduce overall cancer mortality with a shift towards catching cancer early when it can be cured.
Sometimes when I talk to people about tests of this nature, their reaction is “Eeesh, I don’t wanna know!” I have a high hereditary risk for cancer, so I totally get it. When life feels good — everything is going smoothly, you’re happy, things seem under control — the last thing you want to think about is something as scary and life-changing as a cancer diagnosis. But, what can really disrupt your life is a late-stage cancer diagnosis.
My hope is that the Galleri test becomes a regular cancer screening tool just as the others we currently use: mammograms, colonoscopies, pap tests, lung scans, and prostate exams.
When you catch cancer early, your treatment options are so much broader and more effective, even for the cancers we often think of as untreatable (such as pancreatic cancer).
The Galleri test gives you the best chance of maintaining your quality of life and everything you love so much. That’s why I did the test myself recently (all clear!) — I wanted peace of mind. I wanted to know that there’s nothing I need to worry about right now and that I can just focus on the things that make life so worthwhile.
I am currently only putting in orders for this test for my consulting clients. If you are not a client and you are interested in doing your own Galleri test, please request the test from your family doctor. If they aren’t yet familiar with it, forward them this interview. That is how I first learned of this test, from one of my amazing clients (thank you, A!).
If you would like to learn more about how to become a client, click here.