Frequently asked questions
Answers about tissue collection, processing, storage, and cost. Hover over or tap any question to see its answer.
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We typically require at least 250 mg of tumor tissue by weight, or ≈250 mm³ by volume (about the size of a pencil eraser). More is always better, as it increases the chances of extracting high-quality RNA and proteins for future immunotherapy. Less tissue may still be used successfully, especially if densely cancerous, but overall opportunities may be reduced. This will be tested early in the Immunocine pathway if/when the patient wishes to proceed with Immunocine treatment.
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Immunocine’s Dendritic Cell Immunotherapy (IDCT) is designed for solid tumors that can be safely biopsied. This includes cancers of the breast, prostate, colon, pancreas, ovary, kidney, lung, skin (melanoma), and many more.
Because the treatment uses the entire RNA and protein library of your tumor, it is not limited by specific mutations or biomarkers. In fact, it can cover multiple mutations at once, which improves the potential of immunological success even if your cancer evolves over time.
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No. Preserving tissue does not guarantee future eligibility. Final approval depends on many factors, including your health status, organ function, and disease characteristics at the time you are ready for treatment. Preservation simply ensures that you will have viable tumor material available if you are a candidate later.
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If you already meet eligibility criteria and are interested in treatment now, you may not need preservation. Instead, you should work with our Immunocine medical review team about direct enrollment in the treatment program. Preserve is mainly for patients who:
- Are not ready to begin treatment yet
- Are scheduled for surgery or therapy that could destroy or eliminate viable tumor tissue
- Are receiving chemotherapy that may shrink or necrose tumors to the point in which adequate tumor sampling afterwards may be less likely to provide a good quality source for personal cellular immunotherapy.
- Are preparing for radiation therapy, which can make much of the tumor necrotic and unsuitable for vaccine preparation
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We generally have a high degree of success with tissue processing when proper instructions are followed, but there are elements beyond our control that could affect the final quality. Some factors could be:
- The tissue being mostly necrotic (dead) or scarred
- Too much non-cancerous material in the sample (fat, connective tissue, or inflammation instead of tumor)
- The tissue being too small to yield enough RNA or proteins
- Improper handling before shipment (delays, temperature issues, or contamination)
- In rare cases, biological variability that limits what can be extracted even under proper conditions
Additionally, once a sample leaves your hospital, it is transported by third-party carriers such as FedEx. While we provide detailed packaging and shipping instructions, we cannot control carrier delays, mishandling, or loss. To reduce risk, we require that shipments are sent between Monday and Wednesday, avoiding weekends when delays are more common.
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No, unfortunately tissue stored for pathology would have been processed and fixed in a manner that renders it unusable for our purposes. Once tumor material has touched a fixative such as parrafin, paraformaldehyde, or formalin, we would lack confidence of antigenic retrieval sufficient to create your product.
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It is very unlikely. We are only able to use tissue that has a documented blood draw within 30 days of tissue resection that shows negative results for the infections listed elsewhere on this website. Given that is unlikely, it is unlikely we would be allowed to use this tissue.
Not usable if:
- Stored in formalin (standard pathology method)
- Left out at room temperature
- Preserved only for routine genetic testing
Possibly usable if:
- Immediately cryopreserved (frozen under precise lab-grade conditions)
- Quantity and quality are sufficient after in-lab testing
- Complete Infectious testing completed within 30 days of tissue procurement
If you believe you have tissue that may meet these criteria, please contact us to discuss possibilities.
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No. Immunocine Preserve is not a pathology lab and cannot provide a cancer diagnosis. Pathology confirmation must be done by your treating hospital or surgeon.
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Yes. Pathology confirmation of cancer is a requirement. Your surgical team should divide the sample so that part goes to pathology and the rest goes to Immunocine Preserve, following our instructions.
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Yes. If a kit cannot arrive in time, your surgical team can still preserve the tissue correctly using standard laboratory methods:
- Flash freezing the sample in liquid nitrogen for at least 2-3 minutes as soon as possible after resection OR
- Submerging the sample in a dry ice–ethanol bath for at least 5-10 minutes as soon as possible after resection
In either scenario, continued storage at -80C or liquid nitrogen is required.
Later, when it is time to ship, the frozen tissue can be transferred into RNAlater Ice solution and shipped to Immunocine Preserve under controlled conditions.
Our team can provide your surgeon with detailed instructions if this situation arises, to make sure the tissue remains usable for future immunotherapy.
The complete infectious panel will still be required within 30 days of this procedure.
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Our team provides step-by-step support to both patients and surgeons. We supply written instructions, preservation kits, and direct coordination with you and / or your surgical team (if willing) to ensure tissue is handled correctly. We are available to answer questions and collaboratively work to best ensure all requirements are met. You won’t go through the process alone — we’re here to help at every step.
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With respect to biosafety parameters of our ISO-7 certified laboratories in Mexico, we are prohibited from working with any tissue or blood positive for one of 8 infections. We cannot process and utilize your tumor material until we have received valid documentation that you are negative for 8 infections. Those infections include:
- HIV-1/2 antigen and antibodies 4th Gen (CPT: 87389)
- Hepatitis B antigen (CPT: 87340)
- Hepatitis C antibody (CPT: 86803)
- Treponema pallidum (CPT: 86592)
- Trypanosoma cruzi (CPT: 86753)
- Toxoplasmosis (Toxoplasma Antibody IgM (CPT: 86778))
- Epstein-Barr virus (EBV VCA IgM test (CPT: 86665))
- Cytomegalovirus (CMV IgM tests (CPT: 86645))
Importantly, if positive for Toxoplasmosis, EBV, or CMV, we can work with your tissue if obtained after those infections have resolved.
If there is a positive test here (indicating immunological activity) and you believe it may be a false positive, please consider running more specific, confirmatory tests which may include:
- HIV RNA (CPT: 87536)
- Hepatitis B Viral DNA (CPT: 87617)
- Hepatitis C Viral RNA (CPT: 87522)
- Cytomegalovirus DNA (CPT: 87496)
- Toxoplasma gondii DNA (CPT: 87798)
- Treponema pallidum Antibodies (CPT: 86780)
- Epstein-Barr Viral DNA (CPT: 87799)
If these tests are successfully completed within 30 days of the procedure (before or after) and negative, then we are permitted to handle your tissue. As a note, you may want to consider running the tests a couple of weeks before the procedure to have peace of mind that no infection will be in the way. If ultimately we are unable to use the kit because of a positive test result, you would receive a 50% refund.
Any CLIA laboratory or certified doctor can put these tests in for you. If you need assistance, you will have the opportunity in the Immunocine Preserve portal to request that we facilitate the test orders for you. We are partnered with Ulta Lab Tests, and they will provide required scripts. If through us, it will cost $395.
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After your sample arrives, it will ultimately be processed in our certified laboratories to isolate cDNA, RNA, and tumor proteins. These components are carefully preserved under validated conditions and then stored securely for long-term use.
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When tumor tissue is processed by Immunocine Preserve, it will be stabilized and may be converted into cDNA, RNA and protein preparations stored under validated laboratory conditions. This makes the tissue unsuitable for pathology or outside diagnostic testing afterward. The preservation is optimized only for future personalized immunotherapy with Immunocine.
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Properly preserved material and proteins can remain viable for many years when stored under our validated laboratory conditions. We currently include a two-year storage period with your enrollment in Immunocine Preserve. After that, ongoing storage is available for $250 per year, which also covers additional quality control checks to ensure your material remains usable.
If you later pursue treatment, a portion of your Preserve cost can be applied as a credit toward therapy.
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After your tissue is processed, you will receive an official Certificate of Sample Processing & Secure Storage. This document confirms that:
- Your sample was successfully processed and validated under laboratory-quality standards
- RNA and protein integrity and concentration were measured and met acceptable thresholds
- The material has been safely placed into long-term storage under validated conditions
Your sample will then remain securely stored in our certified laboratory until it is needed for immunotherapy. If, for any reason, the tissue cannot be processed successfully, you will be notified and our refund policy (see FAQ) will apply.
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Yes. Immunocine Preserve uses well-established preservation methods designed to protect the biological integrity of tumor RNA and proteins for extended periods, with the goal of keeping this material usable for years.
However, preservation can greatly slow biological degradation—it cannot guarantee that material will remain usable indefinitely. Over time, RNA and proteins may deteriorate enough that a sample becomes unsuitable for future use. How long the material remains usable varies from patient to patient and tissue to tissue, depending on its initial quality, collection and handling, and the requirements of the intended future treatment. There is no way to guarantee a specific usable lifespan for an individual sample.
Our longest recorded example involved tissue preserved for six years that was successfully used in a patient’s treatment. This is an encouraging example of what may be possible, but it does not establish a guaranteed preservation period or treatment outcome for other patients.
We do everything we can, within the limits of biology, to give your tissue the best possible chance of being usable in the future, if and when you choose to pursue treatment at Immunocine.
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Once collected and processed, the sample becomes the property of Immunocine Preserve. This transfer of ownership is required to ensure proper handling, validated storage, and compliance with regulations.
Importantly:
- Your tissue will only be used to make an immunotherapy product for you, if and when treatment is pursued.
- Immunocine Preserve is HIPAA-compliant and will not share or sell your personal health information.
- No unrelated research or genetic testing will be performed without your explicit consent.
This approach ensures that your material is handled securely and remains ready for you, should you pursue Immunocine treatment in the future.
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The total cost is $4,000, which includes the kit, shipping, laboratory processing, quality control, and up to two years of storage.
If you later proceed with Immunocine treatment, $2,000 of this fee will be credited toward the cost of therapy.
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Kits are non-reusable for other clients. If you purchase a kit that is ultimately not used, or if Immunocine Preserve determines that your collected sample cannot be successfully processed for potential future use, you will be eligible for a 50% refund of the direct kit fees paid.
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You can always contact us at Support@ImmunocinePreserve.com, call us at 1-844-737-1470, or contact us here. We will do everything we can to address any questions or concerns.
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