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TumorSimilis - FAQ

General
What is TumorSimilis?
We maintain and grow a cancer patient's own tumor biopsy in the lab, while retaining the heterogeneity observed in primary cancer patient specimens using patented methods (Pat No. 405589) that we have developed. We then use the patient’s lab grown, living cancer tissue to test and identify drug combinations that would work for the individual patient’s immediate need while also trying to address questions of therapy resistance where feasible. We refer to this culture system as a TumorSimilis culture system. TumorSimilis system represent a further development from the field of organoid biology and help address the time and cost associated limitations with using organoids for answering questions around cancer patient therapy assignment.
How does TumorSimilis testing help with my cancer treatment?
Although cancer patients now have access to a greater number of therapeutic options, these options are very expensive and often associated with many poorly tolerated side effects. Further, each patient’s cancer is different, and likely to respond to only a subset of available therapy options. We streamline the administration of these patient therapies by providing a diagnostic/therapy assignment option that goes beyond inferring therapy response and actually tests drug combinations suitable to an individual patient on their own tumor using TumorSimilis. By being able to grow and keep tissue alive for extended durations, we can accurately determine what works in your particular case and spare you the process of going through unnecessary medication and the side effects and cost associated with this.
How is TumorSimilis different from other precision medicine options?
Most precision medicine tools currently in use face two significant disadvantages. First, they work primarily with ‘dead’ i.e formalin fixed paraffin embedded, or frozen tissue. As a consequence, any profiling done on a tumor represents a snapshot of how the tumor behaved at a certain point in time. However, tumors, much like all tissue in a human body, are dynamic and respond to the challenges they face to their survival in different ways. Second, they rely on deriving inferences for tumor behavior on these snapshots, such as looking at how much of a few protein markers are expressed, or at nucleic acid (DNA/RNA) expression patterns. The genome and the proteome is unfortunately very complex and subject to so much dynamic regulation, that it is difficult to directly correlate protein and nucleic acid changes to therapy options. Our TumorSimilis systems overcomes these issues by working with living tissue in a manner that captures its’ dynamicity over extended durations and assessing drug responses on living tissue.
What evidence do you have that your system works?
We are currently conducting such trials in collaboration with Paterson Cancer Center Chennai, India, where we treat TumorSimilii derived from consented volunteers with a suspected malignancy with the same therapy as prescribed to the patient. We have processed over 150 biopsy samples from multiple cancers including lung, breast, rectal and neuroendocrine tumors and have observed an over 90% concordance between TumorSimilis drug sensitivity and patient therapy response. These numbers are far beyond what is currently observed with other precision medicine options and compare favorably with similar trials conducted with organoid and explant based culture systems.
Technical FAQ
What tissue types can you work with?
We have had success culturing and testing therapy option with most solid tumors.
How much sample do you need?
Cellularity is a greater consideration in questions around how much tumor sample we need. Usually we are able to get enough material for TumorSimilis assays from two passes of a biopsy needle. That is, `~1-2 cm3 of tissue.
What should the biopsy sample be placed in to keep it alive for TumorSimilis culture?
We provide a transport medium that can be used to transport tissue to our lab for processing if received within 48 hours and shipped on ice as per the S.O.P we have generated for tissue transport.
What else do you need other than the tissue sample?
1. A signed consent form from the patient.

2. A note confirming the patient’s details and any histopathlogy reports help fine tune our assays based on tissue type.

3. In addition, a filled list of what medications should be tried out helps.

Can you work with formalin fixed tissue?
Not for TumorSimilis culture. We need living tissue for this process.
What biopsy types can you work with?
Cellularity is a major consideration for what we can do and test w.r.t therapy options. We have successfully worked with surgical excisions, needle biopsies and cells from aspirational cytology as well. Where surgical biopsies are used, we recommend that the tissue provided is confirmed to be tumor tissue.
Can you work with biopsy samples from lymph nodes or metastases?
Yes. Provided sufficient number of tumor cells are present.
What are you measuring?
Our assessment of tissue drug sensitivity works on a combination of metabolic activity, cell death and cellular morphology.
How long does your test take?
Short term culture- we test 5 drugs or drug combinations that the oncologist is interested in. We usually provide a report within 5-7 days from receiving the sample. Where relevant we do update the oncologist on subsequent results and drug sensitivities. Next, over a 20 day long period, we try and test 15-30 other therapy options that may be of interest to further fine tune therapy options that may be considered. Where requested, we also try and simulate therapy resistance and provide answers by preempting what the Tumor simili and thus the patients tumor will be sensitive to once therapy resistance occurs
Can your test work with Radiation sensitivity?
In theory yes, we have reason to believe the system will work with identifying radiotherapy sensitivity too. However, we are currently not set up to do this on a regular basis due to the sheer amount of regulation (rightfully so) that dealing with radioactive material is subject to from the government
What therapy options can you test?
We have tested most standard chemotherapy options, targeted antibodies and small molecules and also immunotherapy options. Despite our TumorSimilis system not currently being designed to work against tumor vasculature targetted therapies, we have had some success in predicting response from these drugs too using a combination of cell morphology and metabolic activity.

For immunotherapy, we recommend providing 5-10 ml of patient venous blood to enhance the accuracy of our studies.

Do you bank samples?
Yes we bank tumor tissue for two reasons. It provides us a starting point incase a patient turns up with recurrence at a much later date. It helps us accelerate our research process towards better a better understanding of cancer and how it can be tackled.
Medico-legal FAQ
Is the oncologist obliged by your test to prescribe only what you recommend?
Absolutely not. We believe there is ultimately no replacement for a doctors accumulated experience. What we try and do is provide a tool that advises the doctor on what to consider using and provide him with the confidence to try a certain path where he may have to choose from multiple. The ultimate decision on what to use remains with the Oncologist and the treatment team
How do you choose what drugs you test?
First priority is always given to the oncologist’s recommendations for testing. We limit ourselves to FDA approved therapeutics and NCCN guidelines unless otherwise asked to. If there are additional wells available for testing, we consider testing options from our armamentarium. We will share all these results with the oncologist.
Bio-banking- what if my sample is used by other entities?
Your samples are stored de-identified of any personal information, that can only be accessed through a secure standalone computer. Where your samples are shared with pharma/academic or other entities for research purposes, it will be in accordance with ICMR rules for tissue handling and with your oncologist’s permission