Find answers to the Frequently Asked Questions
We understand that getting the right information is of the most importance to making the right decision. Don’t hesitate to Contact Us if you have any questions!
The SAGE Oncotest™
What is the SAGE Oncotest™?
The SAGE Oncotest™ is based on the best-in-class functional profiling platform, measuring how a cancer responds to various treatment options ex-vivo, i.e. in our lab. After many years of research, the SAGE Oncotest™ is now available for oncologists and patients to provide data on which medications are most likely to be effective against a patient’s cancer.
How does the SAGE Oncotest™ work?
The SAGE Oncotest™ works in 4 simple steps.
- Fresh, live cancer tissue is obtained during a surgery or biopsy and shipped to SAGE overnight.
- SAGE processes your tissue, creates hundreds of small tumor fragments or microtumors, and treats them with a range of different drug and drug combinations that have the highest chance of being effective against your cancer.
- After several days of exposure, we look at what effect the medications had on the viability and proliferation of the microtumors and analyze the results.
- Within 7 to 10 days a SAGE Oncotest™ Report is issued for you and your oncologist so that you can make the most informed decision.
How is the SAGE Oncotest™ different from other tests I might have had already?
Most standard tests—like pathology or genomic sequencing—look at the cellular and tissue structure or at the DNA of the cancer cells. The pathology results are important for a definitive tumor type diagnosis and staging, but cannot predict whether a patient will or will not respond to a certain therapy. Genomic sequencing can help identify certain cancer type characteristics or mutations of the tumor, but they can usually not predict whether your specific tumor will respond to a treatment.
In contrast, the SAGE Oncotest™ measures how your own live cancer tissue reacts to a wide range of medications ex vivo. Instead of guessing based on biomarkers or genomic mutations, we observe real-time responses, giving you and your doctor practical, personalized insight to guide therapy decisions.
How is the SAGE Oncotest™ different from genomic sequencing?
Genomic sequencing is a valuable diagnostic tool to identify certain changes (mutations) of your cancer’s DNA that are known to affect the cancer’s cellular pathways. Furthermore, several therapies have been developed to specifically target such pathways (actionable mutations) that tend to be more effective, more specific, and have less side effects than chemotherapies (targeted therapies). However, only about 1 of 4 cancer patients have such actionable mutations and therefore for the majority of patients genomic sequencing cannot be used for therapy decisions. Furthermore, there are now multiple drugs targeting the same mutations (genetic changes/defect), but only the SAGE Oncotest can provide additional information which of those drugs are most likely to work.
Thus, the beauty of the SAGE Oncotest™ is that it does not require the presence of any biomarkers or genomic mutations, so that we have actionable information in 88% of our cases, both for legacy chemotherapies as well as for targeted therapies. In other words, the live microtumors are exposed directly to the medications which are considered for your therapy.
Does the SAGE OncoTest™ identify specific genetic mutations, like genomic sequencing?
The SAGE Oncotest™ does not look for genetic mutations. It is a functional precision medicine test, which examines ex-vivo the reaction of live tissue to medications independent of any biomarkers or mutations.
Eligibility: Who is it For?
Who is eligible for the SAGE Oncotest™?
The SAGE Oncotest™ is intended for patients with solid tumors, especially those facing aggressive, late-stage, metastatic, or recurrent disease. It is most helpful when treatment decisions involve chemotherapy, targeted therapy, or other systemic options.
You may be eligible if:
- You have a solid tumor,
- You are scheduled for surgery or a biopsy that can provide fresh, live tumor tissue, and
- You will likely require chemo- or targeted therapy.
Is the SAGE Oncotest™ Right for Me?
While the SAGE Oncotest™ can be used for most types of solid tumors, a physician’s prescription is required.
To quickly check whether you might qualify and benefit from the test, we recommend taking this 5 min questionnaire.
Which Cancers Can the SAGE Oncotest™ Test?
The SAGE Oncotest™ can test almost all cancers, including:
- Ovarian and other gynecological cancers;
- Triple negative, BRCA positive, metastatic, and other aggressive breast cancers;
- Colorectal and other gastro-intestinal cancers;
- Glioblastoma and other aggressive brain cancers.
- Cancers of unknown origin (cancers of unknown primary, CUPs) and other rare cancers.
The SAGE Oncotest™ is not indicated for:
- Very slow growing cancers of limited clinical relevance, e.g. low-grade breast or prostate cancers.
- Early cancers where surgical excision is generally curative, e.g. small skin cancers, small (hazelnut size or smaller) breast cancers.
If I already had a biopsy or surgery, can we use that tissue or do I need another biopsy for the SAGE Oncotest™?
The SAGE Oncotest™ works with fresh, live tissue to see how your cancer responds to different medications. Thus, if you already had a previous biopsy or surgery, your sample was most likely placed into a preservative (e.g., in formalin) and subsequently paraffin embedded to cut and stain thin slices (histological slides, aka pathology), so that tissue will be dead and can no longer be used for the SAGE Oncotest™.
However, if you’re scheduled for a new procedure, you can ask your doctor to collect fresh tissue for the test to be sent to SageMedic. Just be aware that some cancer centers may claim ownership of excised tissue in their consent forms, so it’s important to communicate your intent ahead of time.
How to Access It
Does the SAGE Oncotest™ Require a Tissue Biopsy?
Yes, we use live tissue for the SAGE Oncotest™ which can be attained during a surgery or with a core needle biopsy (not a fine needle biopsy). However, if you are having an ascites or pleural effusion that needs to be drained, we may be able to avoid an additional biopsy because those bodily fluids do often contain enough cancer tissue for testing.
Why does the SAGE Oncotest need a Fresh and Viable Cancer Biopsy and not just a Blood Draw?
The SAGE Oncotest™ relies on live cancer cells to accurately measure how your tumor responds to different treatments. This means the tissue needs to be fresh and viable—something that can’t be achieved with preserved samples from past biopsies, which are no longer alive. Similarly, blood samples typically don’t contain enough live tumor cells to perform the test. That’s why tissue from a recent surgery, biopsy, or sometimes fluid samples like ascites or pleural effusion is needed so that we can isolate enough viable cancer tissues for testing.
What Do I Need to Do to Get the SAGE Oncotest™?
These are the few easy steps:
- Find out if you are eligible (see related FAQs).
- If you are eligible and are likely undergoing a surgery or biopsy in the near future, schedule a complementary 1:1 consultation with Dr. Apfel himself.
- Coordinate with your doctor to get an order for the SAGE Oncotest™
- Sign the SAGE Oncotest™ Purchase Agreement, pay for the test, receive the SAGE Oncotest™ shipment kit and coordinate with your clinic to ensure we receive your cancer biopsy in the best possible condition.
How long does it take to get results from the SAGE Oncotest™?
In contrast to organoid models, which try to grow a tumor over several weeks or months, we are recreating your tumor tissue into fragments and microtumors overnight so that we can start testing on the next day. Thus, the whole process from the arrival of the tissue in our lab to the finalized report takes only 7 to 10 days. During this time we create microtumors, expose them to a panel of medications, assess their response, analyze the data, and generate the final report.
Is the SAGE Oncotest™ covered by insurance?
SageMedic is a CLIA-certified laboratory registered in California, meeting the quality standards set by the Centers for Medicare and Medicaid Services. However, the SAGE Oncotest™ is currently not covered by insurance.
Test Value and Clinical Impact
How Effective is the SAGE Oncotest™
- Our meta-analysis has shown that tumors treated using a functional profiling assay like the SAGE Oncotest™ are twice as likely to respond to therapy compared to those treated based on a physician’s standard choice.
- One of the key advantages of the SAGE Oncotest™ is that it provides actionable information in 88% of cases, which is much more useful than genomic testing that provides actionable information in only 26.8% of cases.
- While no test is perfect, based on data from our predecessor assay, the Extreme Drug Resistance (EDR) test, we expect over 90% ‘negative predictive value,’ meaning that if your cancer does not respond to extremely high dosages of a medication in our lab, it is very unlikely that this medication will work for you. Our assay goes beyond that by measuring sensitivity and resistance, informing your oncologist about the most effective treatment options.
How can the SAGE Oncotest Help to Avoid Ineffective Treatment?
Not every tumor responds to a specific medication. And although the kind of tumor makes a response more or less likely, a sure prediction is not possible. The SAGE Oncotest takes the individual tumor tissue and tests a wide range of medications in the lab. Sometimes, even when exposed to very high concentrations of a drug—higher than would ever be given to a patient—tumor cells continue to grow and divide. In such cases, the medication is unlikely to be effective in the body and can be ruled out in favor of a more promising medication, helping to avoid unnecessary side effects.
How does the SAGE Oncotest™ help my doctor choose the right treatment for me?
The SAGE Oncotest™ provides your doctor with direct, real-time data on how your unique tumor responds to a range of medications in the lab. Instead of relying only on standard protocols or genetic markers, your doctor can see which treatments actually worked—and which didn’t—on your live cancer cells. This helps your doctor make a more data-driven, personalized treatment decision.
Will I get a recommendation for the best therapy?
The SAGE Oncotest evaluates a variety of medications at different concentrations and combinations in the lab and provides a detailed resistance and viability profile for your tumor. While it does not issue a direct recommendation, the results offer valuable insights to help you and your oncologist choose the most effective treatment—considering clinical guidelines, your overall health, and potential side effects.
Broader Use and Innovation
Can the SAGE Oncotest™ help with finding personalized or alternative treatments?
Yes, absolutely. Personalizing treatment is one of the main purposes of precision medicine and of the SAGE Oncotest™. While we primarily focus on NCCN-guideline therapies, we can also include off-label cancer drugs, repurposed medications, and drugs currently used in clinical trials and their combinations. Because the test can evaluate this wide range of medications it can uncover treatment options that may not have been previously considered.
Can the SAGE Oncotest™ help me find new therapies or clinical trials for my cancer?
The SAGE Oncotest™ is designed to personalize your treatment by testing your own tumor tissue against a wide range of medications. We can include new medication or those which are currently tested in phase II, III, or IV clinical trials. This could help you and your doctor decide whether a clinical trial could be a good next step for you and if so in which trial to participate if there are several options. However, the SAGE Oncotest™ cannot test immunotherapies.
Can the SAGE OncoTest™ detect drug resistance or sensitivity in ways that genomic sequencing cannot?
Yes. The SAGE Oncotest™ directly measures how your live cancer tissue respond to medications by observing their survival and metabolic activity in the lab. This provides real-time insight into drug sensitivity or resistance. Genomic testing, on the other hand, looks for mutations in DNA that might indicate a response to certain drugs—but those mutations are found only in a minority of patients, and having such a mutation does not guarantee the treatment will work. The SAGE Oncotest™ shows how your tumor actually behaves when exposed to drugs, which offers a more functional and personalized view.
Supporting Information
Why are Standard Biopsies Often Insufficient to Identify Best Treatment Choices?
- Standard biopsies are generally placed into a formalin solution to preserve the tissue and prepare it for further processing, i.e. H&E staining for a definitive histological diagnosis. Because this kills the tumor cells it is impossible to observe ex-vivo (in the lab) how a tumor responds to various therapies.
- Furthermore, even though two patients might have the identical histological tumor type, every patient’s cancer is uniquely different, and so the patient’s responses to therapy vary widely from no response and continued cancer growth to partial or complete remission.
- Sometimes, the biopsies are stained for special biomarkers (e.g. estrogen receptors, HER2 receptors, etc.), that can inform which therapy might be more likely to work or not. While this information is valuable, it is often not enough to determine whether a treatment will work or not.
- Genomic sequencing to identify driver mutations that affect the cell behavior is a special case of biomarkers, and for some of those mutations (e.g. EGFR receptors, etc.), targeted therapies are available that are known to be more effective while having less side effects (e.g. Herceptin). Again, this is valuable information, however, only 26.8% of patients do have actionable driver mutations, so that for most cancer patients, the best therapy remains unknown.
- Thus, the SAGE Oncotest™ is not to replace current diagnostics but to provide you with actionable insights you would otherwise not have. In fact, because our test is using fresh viable tissue and does not require any biomarkers nor genomic sequencing testing, it yields actionable information in 88% of cases for you in just 7-10 days.