Frequently Asked Questions

How much tumor material is needed to ultimately use with Immunocine?

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. If less tissue is available, our lab can still evaluate it to see if it is usable.

Which cancers could this potentially be useful for? Which mutations?

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, even as your cancer evolves.

Once my cancer is sent to Immunocine Preserve, I understand I will not be able to retrieve it later. Why not?

When tumor tissue is processed by Immunocine Preserve, it is stabilized and 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 use.

Does preserving tissue now guarantee I will be a candidate for the Immunocine treatment later?

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.

What if I think I might be a good candidate now for the Immunocine treatment?

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 tumors to the point where future use becomes impossible

·     Are preparing for radiation therapy, which can make much of the tumor necrotic and unsuitable for vaccine preparation

What do you do with the tumor material sent?

Once your sample arrives, it is processed in our certified laboratory to isolate both cDNA (for future RNA use) and tumor proteins. These components are carefully preserved under validated conditions and then stored securely for long-term use.

If the material passes all quality and integrity checks, you will receive an official Certificate of Processing & Secure Storage. This document confirms that your tumor sample has been successfully processed, validated, and is now available for future Immunocine immunotherapy.

How long will it last once processed by Immunocine Preserve?

Properly preserved genetic 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.

Why can’t you accept the tissue if positive for specific infections?

With respect to biosafety parameters of our ISO-7 certified laboratory in Cancun, 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))
  • Epsetin-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 the more specific, confirmatory tests. That can 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.

What if I had tumor previously stored for pathology? Can that be used?

No, unfortunately we will not be able to accept that tissue, as it would be unlikely that the complete infectious panel was run within 30 days of tissue extraction.  This would prohibit us from using the tissue.

What if I had tumor previously cryopreserved? Can that be used?

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 in this document. 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 suficient after in-lab testing

We're happy to evaluate any stored tissue, but will need to review viability to ensure success.

Can Immunocine Preserve handle the pathology requirements? Can Immunocine Preserve diagnose me?

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. We recommend always sending part of your sample to pathology for confirmation.

Should my surgeon send some sample to pathology for tumor confirmation?

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.

What if the kit cannot arrive in time for my procedure? Is there any way the doctor can save the material correctly so that we can send to Immunocine Preserve later?

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 1–2 minutes, or
  • Submerging the sample in a dry ice–ethanol bath and then storing it at –80°C or colder

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.

How much does preservation cost?

The total cost is $6,000, 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.

Who owns my tissue after it is preserved?

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.

How will I know my sample is safe?

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.

Do you offer refunds if my sample cannot be used?

Kits are non-reusable for other clients. If you purchase a kit that is ultimately not used, or if Immunocine Preserve determines that you collected sample cannot be successfully processed for potential future use, you will be eligible for a 50% refund of the direct kit fees paid.

What could make a tumor sample “bad” or unsuitable for preservation?

Most samples are successfully processed — our current failure rate is less than 5%. However, some factors can prevent successful preservation, including:

  • 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 strongly recommend that shipments are sent between Monday and Wednesday, avoiding weekends when delays are more common.

Is there any chance my preserved sample won’t be usable in the future?

Our process is designed to preserve tumor RNA and proteins in a way that keeps them stable for many years. When samples arrive, we successfully extract usable material in over 95% of cases. Once preserved, the chance of long-term degradation to the point of being unusable is estimated at around 2%.

This small risk exists because, over time, all biological material can naturally degrade, even under optimal conditions. To minimize this, we use validated preservation methods, secure long-term storage, and regular quality checks. Patients also receive a certificate of processing at the start to confirm their sample met quality standards when preserved.

In short: while no biological system is completely risk-free, the vast majority of preserved samples remain fully viable for future use.

Who can help me and my doctor with the process?

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 sure all requirements are met. You won’t go through the process alone — we’re here to help at every step.