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Find answers to
Frequently
Asked Questions
We understand that getting the right information is of utmost importance when discussing care options with your healthcare team. Don’t hesitate to contact us if you have any questions!
The SAGE
Oncotest™
The SAGE Oncotest™ is based on an advanced functional profiling platform, measuring how a cancer responds to various treatment options ex-vivo, i.e. in our laboratory. After many years of research, the SAGE Oncotest™ is now available to oncologists and patients providing laboratory insights about how tumor tissue responds ex vivo to selected therapies.
The SAGE Oncotest™ works in 4 simple steps.
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Fresh, cancer tumor tissue is obtained during a surgery or biopsy and shipped to SAGE overnight.
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SAGE processes the tissue into multiple small cancer tissue replicates, and evaluates them against a range of drug regimens and combinations selected for laboratory evaluation based on the patient's cancer type.
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After several days of laboratory evaluation, we measure how the cancer tissue responds to each medication and analyze the results.
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Within 7 to 10 days a SAGE Oncotest™ Report is issued for you and your oncologist to help support treatment planning discussions.
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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 and genomic sequencing provide important diagnostic and molecular information but may not fully characterize how a tumor responds to therapies in all patients.
In contrast, the SAGE Oncotest™ measures how your own cancer tissue responds to a wide range of medications ex vivo. Instead of relying on biomarkers or genomic mutations alone, our laboratory evaluation measures ex-vivo tissue responses to selected medications.
Genomic sequencing is an important molecular diagnostic tool that identifies specific genomic alterations associated with certain cancers and therapies.
The SAGE Oncotest™ is different because it evaluates ex-vivo tissue responses to selected therapies in a CLIA-certified laboratory setting. Functional profiling may provide additional laboratory insights that can complement genomic information as part of broader treatment planning discussions.
The Sage Oncotest™ is not a replacement for genomic sequencing or other standard diagnostic approaches.
The SAGE Oncotest™ does not look for genetic mutations. It is a functional profiling assay that evaluates ex-vivo responses of cancer tissue to selected medications in our CLIA-certified laboratory.
Eligibility:
Who Can Access It ?
The SAGE Oncotest™ is intended for patients with solid tumors, especially aggressive, late-stage, metastatic, or recurrent tumors. It may be considered in situations where treatment planning involves chemotherapy, targeted therapy, or other systemic options.
You may be eligible if:
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You are scheduled for surgery or a biopsy that can provide fresh, viable tumor tissue, and
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Your treatment plan may involve chemotherapy or targeted therapy.
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While the SAGE Oncotest™ may be used for most types of solid tumors, a physician’s order is required.
To determine whether the test may be appropriate for your situation, we recommend completing the eligibility questionnaire.
The SAGE Oncotest™ may be used in a range of solid tumors, including:
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Ovarian and other gynecological cancers;
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Triple negative, BRCA positive, metastatic, and other advanced breast cancers;
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Colorectal and other gastro-intestinal cancers;
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Glioblastoma and other brain cancers.
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Cancers of unknown origin (cancers of unknown primary, CUPs) and other rare cancers.
The SAGE Oncotest™ is generally not intended for:
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Very slow growing cancers of limited clinical relevance, e.g. low-grade breast or prostate cancers.
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Early cancers where surgical excision is generally curative, e.g. small skin cancers, small (hazelnut size or smaller) breast cancers.
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The SAGE Oncotest™ works with fresh, viable tissue to evaluate ex-vivo laboratory tissue responses to selected 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), so that tissue is generally no longer viable for ex-vivo laboratory evaluation 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 have specific policies regarding excised tissue specimens in their consent forms, so it’s important to communicate your intent ahead of time.
How to
Access It
Yes, we use fresh cancer 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 have abdominal fluid (ascites) or chest fluid (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.
The SAGE Oncotest™ requires viable cancer tissue to accurately evaluate drug respond in the laboratory. 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 viable tumor cells to perform the test. That’s why tissue from a recent surgery, biopsy, or sometimes fluid samples like abdominal fluid (ascites) or chest fluid (pleural effusion) is needed so that we can isolate enough viable cancer tissue for testing.
These are the few easy steps:
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Find out if you are eligible by completing the eligibility questionnaire.
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If you are eligible and are likely undergoing a surgery or biopsy in the near future, schedule a complementary 1:1 consultation with a member of the SageMedic team.
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Coordinate with your doctor to get an order for the SAGE Oncotest™
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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.
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In contrast to organoid models, which try to grow a tumor over several weeks or months, we process your cancer tissue into testable replicates within 24 hours, and start testing the next day. Thus, the whole process from the arrival of the tissue in our lab to the finalized report takes only 7 - 10 days. During this time we evaluate the tissue against a panel of medications, assess the results, analyze the data, and generate the final report.
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
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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.
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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.
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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 promising treatment options to consider.
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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.
The SAGE Oncotest™ provides your doctor with laboratory-based data on how your tumor tissue responds to a range of medications. Instead of replying only on standard protocols or genetic markers, your doctor receives a detailed drug response profile showing which treatments showed activity-and which did not-in laboratory evaluation of your cancer tissue. This helps your doctor make a more data-driven, personalized treatment decision.
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 evaluate the most appropriate treatment options for you—considering clinical guidelines, your overall health, and potential side effects.
Broader Use
and Innovation
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.
The SAGE Oncotest™ is designed to personalize your treatment by testing your own tumor tissue against a wide range of medications. We can include off-label cancer drugs and medications currently being evaluated in 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.
Yes. The SAGE Oncotest™ measures how cancer tissue respond to medications by evaluating cellular activity in our laboratory. This provides functional 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
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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.
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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.
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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.
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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.
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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 in just 7-10 days. ¹Based on SageMedic internal validation data.
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