DIRECT YOUR CARE, DEMAND SEQUENCING
Bryce Olson was diagnosed with aggressive stage 4 prostate cancer. When the standard of care didn’t work, Bryce turned to genomic sequencing which allowed his doctors to identify specific molecular drivers of his disease and identify specific treatments and clinical trials that were a better fit for his specific cancer.
“The driver of my cancer was hidden in my DNA. I asked my doctors to ‘Sequence Me.’ The insights from genomic sequencing opened new doors and saved my life. Fight cancer differently with data.”
JOIN THE MOVEMENT
Wear it to your next doctor‘s appointment and start the conversation about getting the DNA of your cancer profiled. Get on the path to precision medicine. Go beyond the standard. Be your own best advocate and demand to be sequenced.
INDIVIDUALIZE YOUR CARE – DEMAND SEQUENCING
Read these frequently asked questions and build confidence to understand the science, open new doors, and overcome objections or pushback. Be empowered and get more personalized care.
Q. What do you mean by “Sequence Me?”
‘Sequence Me’ is a call to action and a new movement. All people suffering from cancer deserve new insights into what is driving their disease. To get that, we need to demand genomic sequencing from our medical teams in order to understand those molecular drivers that are hidden in the DNA of our tumors. The insights from genomic sequencing can open new doors for treatment and extend your life. At the very least, it will empower you with more data and insights and help you understand your cancer better.
In the future it is expected that many more doctors will eventually offer this and many more patients will get personalized diagnostics and medicine. Why? Because the advances and affordability in new solutions like this driven by science and technology innovation will make it embarrassing for healthcare providers to not offer it. But today is still early days. One great way to accelerate the adoption of new innovation is through greater education, awareness building, and forming community. Sequenceme.org is going to do that. We want to bring ‘strength in numbers’ to new innovation like this. We need to accelerate this and YOU have the power to demand it. The supply side that offers these services will respond when we as patients demand it. So let’s collectively wake up and demand “Sequence Me!”
Q. What is genomic sequencing?
The genome is the complete set of genes or genetic material present in a cell or organism. The human genome is made up of 20,000 genes and more than 3 billion base pairs of the genetic letters known as DNA building blocks (A, T, C, Gs). A genome sequence is a specific order of those DNA building blocks (A, T, C, Gs) and ‘sequencing’ is a critical first step to understanding it and figuring out the order of those DNA nucleotides, or bases, in a genome—that make up who you are.
Q. What is genomic sequencing for cancer?
Cancer is a genetic disease—that is, it is caused by changes in DNA that control the way cells function, especially how they grow and divide. These changes can be inherited, but most arise randomly during a person’s lifetime, either as a result of errors that occur as cells divide or from exposure to DNA-damaging carcinogens. These are referred to as “somatic” mutations or “acquired” mutations that are different from ‘germline’ or inherited changes.
Each person’s cancer has a unique combination of these genetic changes, and tumor DNA sequencing—sometimes called genetic profiling or genetic testing—is a test to identify these unique DNA changes.
Knowledge of the genetic alterations in your cancer can help determine a treatment plan. Some treatments—particularly, some targeted therapies—are effective for people whose cancer cells have specific genetic alterations that cause the cells to grow out of control (these are sometimes called “driver” mutations).
For example, mutations in the EGFR gene that make cells divide rapidly are found in some people’s lung cancer cells. A patient whose lung cancer cells harbor an EGFR mutation may respond to treatment with drugs called EGFR inhibitors. Clinical tumor DNA sequencing can reveal whether a patient’s lung tumor has an EGFR mutation.
Tumor DNA sequencing is at the crux of precision medicine: care tailored to the molecular characteristics of each patient’s disease.
Q. Who is eligible to get “sequenced”?
Anybody with cancer. For patients with hematologic malignancies (blood cancers) and soft tissue sarcomas, sequencing can be used early at diagnosis, for prognostication, and to guide overall clinical management. Folks with solid tumors (i.e. prostate, breast, lung, pancreatic, etc) become eligible when they have more advanced disease – and they should absolutely demand it when they become stage III/IV. Unfortunately, more than 60 percent of advanced cancer patients today receive no genomic testing — and are often relegated to highly toxic and ineffective therapies. Let’s change that!
Q. Who offers genomic sequencing / tumor DNA sequencing?
Many academic cancer centers across the U.S. offer this and you just need to ask your medical oncologist for it. For example, Memorial Sloan Kettering in NYC offers the FDA approved MSK-IMPACT test. There are also many commercial diagnostic testing companies that offer amazingly informative tests, including Foundation Medicine, Ambry Genetics, Tempus, Perthera, and Caris Life Sciences among others. There are lots of options and your doctor may have a preferred provider for this, so just ask.
Q. Where do you get this done?
Demand it first from your doctor. Your doctor will then likely coordinate with the pathology department to get a tumor sample from you (i.e through previous biopsy or surgically removed sample that is sitting preserved in a lab), or possibly through new blood draw. The doctor will then have those samples send over to one of the places above. They will also work with your health insurance provider on coverage / reimbursement for the diagnostic test.
Q. Will my insurance cover the costs for this?
Most diagnostic test companies will accepts all insurance plans. However, that doesn’t mean your insurance company will agree to cover the costs. It is very possible that the test provider will not be in-network with the providers in your insurance plans. If you are uninsured, or if you have insurance and cannot afford the applicable out-of-pocket cost, you also have options. You can fill out a financial assistance application from the diagnostic test companies to determine upfront what your maximum out-of-pocket expense might be. Payment plans may also be available.
Regarding coverage, fortunately, the Centers for Medicare & Medicaid Services (CMS) issued a final National Coverage Determination (NCD) for patients who receive next generation sequencing (NGS) testing with an assay that meets the coverage criteria. Medicare and Medicare Advantage patients who receive testing with FoundationOne CDx™ (from Foundation Medicine) the first FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors incorporating a broad set of companion diagnostics, will be eligible for coverage.
For those who have private health insurance coverage through employers, or direct purchase coverage, here is some strategic guidance to get those tests covered by insurance. First, push your physician to order the test and ask them to communicate to your insurance company that you have recurrent, relapsed, refractory, metastatic, or advanced (stage III or IV) cancer (assuming this is the case for your condition). Include the fact that you’ve decided to seek further cancer treatment, and that you haven’t previously been tested using the same next generation sequencing (NGS) test that your doctor is ordering for you. If you are denied / rejected by insurance than try and seek financial assistance from the diagnostic testing company or hospital / cancer center that is offering the service. If this still fails to address the payment issue, we’d like to hear from you. Sequenceme.org isn’t set up to provide financial assistance for these tests, but we’re more than happy to use social media to shine a light on organizations that are pushing back on enabling you to get these tests approved and covered.
Q. Why don’t insurance companies cover the costs all the time?
Reimbursement can be challenging because these are early days of something new and revolutionary. Science and technology advancements are occurring at exponential rates. Healthcare is still moving at more of a linear step-wise fashion. Sometimes payers will decline coverage because they feel there isn’t enough data to determine the clinical utility of these tests. What’s maddening is that as an industry we won’t be able to generate enough data if we don’t start covering the costs of these clinically validated tests. Catch 22. We need to collectively fix this!
Q. Why is it important to get “sequenced”?
A. Because it helps get the right drug to the right patient at the right time. It’s how we really move to ‘value-based care’ or ‘outcome driven healthcare.’ It can help open new doors beyond the ‘standard of care’ which is more of a one-size-fits-all approach to cancer care that doesn’t take into consideration the uniqueness of you.
Cancer is a genetic disease. The DNA of your cells have become mutated. You need to know the mutations in your tumor. This will help you and your doctor select treatment options, including clinical trials, that are likely to work best for you and may not be considered otherwise. A treatment that works well for one person may not work as well for you.
All advanced cancer patients deserve to have new doors opened. We all want new hope. Besides the standard of care, we have the right to consider targeted therapy (i.e. drugs specifically built to go after the mutations driving your disease), appropriate clinical trials that go after the same molecular targets driving your cancer, or off label treatments that may be effective for your specific tumor mutations. There are also genomic signatures like TMB (tumor mutational burden) and MSI (microsatellite instability) and PD-L1 expression that are biomarkers that are very helpful in determining whether you’d be a good fit for new immunotherapy treatments or not. Don’t you want to know?
Q. How does genomic testing differ from genetic testing?
Genetic testing detects hereditary (inherited from parents) alterations in DNA while genomic testing detects acquired (over the course of a lifetime) alterations in DNA. Acquired alterations are responsible for the majority of cancers and may impact tumor growth, spread, and response to therapy. Comprehensive genomic profiling (CGP) is far superior to single-gene testing that only identifies one or two classes of genomic alterations. CGP’s approach identifies four classes of genomic alterations: base substitutions, insertions and deletions/indels, copy number alterations, and rearrangements. The reason why a CGP is far superior to a single marker test is this: When you only look at just 1-2 things you run the risk of missing the actual targets that were causing the disease. Cancer is an incredibly complex disease and it’s crazy to presuppose that the smartest doctor can look at a specific patient and know the genes of interest. Unlike the standard single marker test — which assumes the site of a cancer’s origin, and looks for a specific genetic alteration — most comprehensive genomic sequencing tests do not presuppose knowledge of the cancer’s exact profile, and just look at everything.
Q. What if my doctor thinks this is a waste of time?
Download the ‘battle card’ we’re offering, print it and bring it to your next doctor appointment. Buying and wearing the t-shirt will also help spark a conversation.
Remind your doctor that cancer is a genetic disease and that the DNA of your cells have become mutated and you want to know what those mutations are. This will help you and your doctor select treatment options, including clinical trials, that are likely to work best for you and may not be considered otherwise. A treatment that works well for one person may not work as well for you. Tell your doctor that you want to expand beyond the ‘One size fits all’ treatments like chemo that everybody with advanced cancer gets, because your cancer is unique from the patient your doctor just saw and will see after you.
In the end, doctors want to know that if they order a test it will have strong predictive power to identify treatment (i.e. who will be a responder vs non-responder) and that the predictive biomarkers found on these tests are also on the patient-relevant clinical pathways/guidelines. It also helps when a test is mandated in a therapeutics’ FDA labeling.
Q. My doctor said there isn’t any new FDA approved drugs for me and is pushing back on ordering the test. What do I do?
Tell your doctor that you want new doors opened. You want new hope. Besides the standard of care, you want to consider targeted therapy, appropriate clinical trials that go after the same molecular targets driving your cancer, or off label treatments that may be effective for your specific tumor mutations. All of these options can be better informed through the results of these tests. If your doctor is still shaking his/her head no, then perhaps it’s time to find a different doctor.
Q. Am I contributing also to the greater good by doing this?
Absolutely! You are helping accelerate cancer research and drug development by doing this. Almost all of the companies that provide these tests partner with bio-pharma clients throughout each stage of drug research and development, from target discovery to commercial launch. We need to develop better drugs, faster. Broad testing of patients would make more data available to bio-pharma companies, accelerating the pace of research and the identification of more patients for clinical trials. Ultimately, that could lead to the development of more effective — and cheaper — targeted drugs. It’s a virtuous cycle. In the future, more patients who receive a genomic diagnostic test like this would have a greater choice of approved treatment options for their specific cancer. We need to accelerate the development of treatments that provide the optimal outcome for every patient diagnosed with advanced cancer.
Q. Do all the test results lead to actionable treatment options?
Foundation Medicine has reported on that. Of the 79,000 cancer patients FMI tested in 2017, 38% percent were matched with an FDA approved therapy, 83% percent were matched with at least one relevant clinical trial, and all of them had at least one of those two outcomes.
Q. What kind of results should I expect from these tests to help guide my care?
Each individual cancer is unique and test results vary depending on the tumor type. When applicable, test results may help identify the following insights.
- New insights into the preferred ‘on-label’ standard of care therapies. This means therapies approved to treat your specific tumor type and shown to be effective in targeting one or more of the alterations found by the test.
- New insights into off-label drugs: These are therapies approved in another tumor type (i.e. breast cancer) but possibly effective in targeting one or more of the genomic alterations found by the test that occur in your tumor (i.e. prostate cancer.)
- A clinical trial evaluating therapies under development which may work by targeting an alteration found by the test that is in your tumor.
Q. Regarding clinical trials, are there good trusted sources out there for me to find the right clinical trial “match” based on having genomic sequencing results?
There’s new innovation going on in this space. Most of the commercial diagnostic test companies listed earlier will offer clinical trial matching as part of their report back to patients and doctors. Other good sources include ClinicalTrials.gov, which is a database of privately and publicly funded clinical studies conducted around the world (though a little challenging to use), Massive Bio that uses artificial intelligence to help match you to clinical trials that cater to your specific cancer type and situation, and Cancer Research Institute that offers a Clinical Trial Finder to aid you in finding the answer to your cancer. As new innovation emerges, we’ll share it with you here.
Q. Isn’t this just for the top 1% of patients with financial means?
A. No. Anybody with advanced cancer can demand and receive this. If your insurance doesn’t cover it, ask for financial assistance from the place doing the test.
Q. Isn’t there a risk that this will accelerate the adoption of drugs that aren’t ready and aren’t safe yet?
This isn’t a trade-off between speed and safety. This is about getting medicines designed specifically for patients who express biological characteristics (biomarkers) that increase the odds that a treatment will actually work for them. FDA is streamlining approvals for these treatments and personalized medicine can arguably have better safety and efficacy profiles than one-size fits all medicine of today.
Disclaimer: SequenceMe.org provides this information as a service. This information and material is strictly for educational purposes only and is not intended as medical advice, is not intended to take the place of medical professionals, or the recommendations of your healthcare team for prevention, diagnosis and treatment of medical issues. We strongly suggest consulting your healthcare team if you have questions about your specific care.
KEEP UP WITH WHAT’S HAPPENING
Bryce Olson was recently featured on KATU Channel 2 News in Portland, Oregon. Watch Bryce’s story and learn how gene testing helped Bryce. “The message I just really want to deliver is: demand sequencing. Demand genomic sequencing.”Read More