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General Questions

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  • What is a benign tumor?

    A benign tumor is a tumor that grows locally, without invading adjacent tissue or spreading to other parts of the body. It can be removed by surgery or by radiation. If there is nothing left of the benign tumor after treatment, you are cured. A benign tumor is therefore in fact not a cancer.

  • What is a malignant tumor?

    A malignant tumor is a tumor that invades adjacent tissue. It spreads to the local lymph nodes or via the blood to other parts of the body and forms distant metastases. A malignant tumor is difficult or impossible to remove in its entirety by surgery or radiation. It spreads by way of thin filaments of cells or individual tumor cells that are difficult to detect and eradicate. Individual such filaments or individual cells, will almost surely already be scattered when the primary tumor is discovered, making local surgical or radiation treatment difficult or impossible. Systemic treatment (treatment that affects the entire body) with chemotherapy, new targeted drugs or immunotherapies are therefore usually necessary. A malignant tumor should not be ignored, on the contrary it needs to be carefully monitored and treated by a specialized physician.

  • Do malignant tumors always need to be treated?

    Malignant tumors are usually treated. An un-managed tumor can have major repercussions including eventual death. If a tumor appears to develop slowly or not at all, it may sometimes be advisable with watchful waiting, but then only under close supervision by the treating specialized physician.

  • What does DNA sequencing mean?

    DNA sequencing means to use chemistry to read the genetic code of your DNA molecules. From that information, one can determine the code of the genes, compare your individual code to what is known to be healthy and thereby identify any potential problems, i.e. oncogenic mutations, and make informed personal treatment decisions.

  • What does oncogenic mutations mean?

    A mutation is called oncogenic if it is involved in the processes that causes cancer. Mutations can either be inherited (i.e. germline mutations) or be developed after birth (such mutations are called somatic mutations). Combinations of germline and somatic mutations, or only somatic mutations, may eventually cause a tumor. Oncogenic mutations are defects in normal genes that cause the cell they reside in to develop in an abnormal way.

  • What is a tissue biopsy?

    En vävnadsbiopsi är ett prov som består av en liten bit av den vävnad man misstänker vara sjuk. En patolog analyserar, med hjälp av mikroskop, vävnadsprovet i syfte att bestämma närvaro och/eller omfattning av en sjukdom, t.ex. cancer. Ett vävnadsprov är invasivt, d.v.s. det kräver oftast någon form av mindre eller större, kirurgiskt ingrepp.

  • What is a liquid biopsy?

    A liquid biopsy is the sampling and analysis of non-solid biological tissue, primarily blood. iCellate uses liquid biopsies to access tumor DNA by way of blood samples. Just like tissue samples, it aims to determine the presence or extent of a disease, e.g. cancer, based on the DNA sequence of the cell fragments. A liquid biopsy is considerably easier on weakened patients since it does not require any form of surgery other than a needle stick in the blood vessel of the arm.

  • What are the benefits of liquid biopsies compared to established medical imaging or tissue biopsy methods?

    Tissue biopsies and medical imaging are established procedures with known advantages and limitations. Blood samples provide a new and powerful method to complement and expand tumor DNA sampling to those situations when there otherwise would not be any sample at all available. The DNA sequence will also improve and simplify the work of detecting, diagnosing and determining the best treatment of cancer in several different ways:

    • X-ray, CT (computed tomography), ultrasound and other medical imaging requires that the tumor has reached a size of more than about 10 millimeters to be visible. If the tumor is smaller, the diagnosis may be delayed or missed. By the time the tumor has reached detectable size by medical imaging, it is often at a later stage in the disease progression, and in some cases up to 12 years after the tumor was first formed from a single, or a few, spreading cells.
    • With a liquid biopsy, CTC (circulating tumor cells) can be detected in the blood as soon as the tumor becomes malignant, i.e. when it first starts to spread.
    • Medical imaging cannot provide detailed information about cells or genes.
    • Liquid biopsies show, through cell analysis and sequencing, both cellular and genetic details (including oncogenic mutations) of the tumor, providing the required molecular information for informed treatment decisions.
    • Some tumors are located in poorly accessible locations so that they are difficult or impossible to sample by biopsy (e.g. in the pancreas or some locations of the brain). The spreading CTC cells can nevertheless be sampled and analyzed.
    • A liquid biopsy can even provide information about a tumor that has not yet been localized, such as the so-called cancer of unknown primary (CUP), where mysteriously only metastases are seen and not the primary tumor.
    • Tissue biopsies can often only be taken once, or a limited number of times, since the patient may be too weak, or the amount of tissue may be exhausted from previous sampling.
    • Liquid biopsies can, within reason, be performed as often as is required without adversely affecting the patient.
    • A tissue biopsy is invasive (requiring some form of surgery) which has its own side effects that can be severe for frail and even for otherwise strong and healthy patients.
    • Liquid biopsy, which consists of only a standard blood draw, is largely non-invasive and almost painless.
    • Tissue biopsies are generally expensive for healthcare because it involves surgical procedures.
    • The costs for liquid biopsies, on the other hand, are low.

Personal cancer screening

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  • What is the purpose of cancer screening?

    Screening means that a larger number of people are examined to provide an opportunity to detect a possible illness, or precursors to illness, even before symptoms occur.

    Cancer screening aims to identify individuals with cell abnormalities that indicate cancer, or a precursor to cancer, in order to be able to make a diagnosis and suggest potential treatment methods at an early stage.

    iCellate's personal cancer screening is done through a regular blood draw, which is then analyzed for possible detection of CTCs (circulating tumor cells). Detection of CTCs is a suspicious finding that would require follow-up investigations to confirm or refute a cancer diagnosis.

  • What is a circulating tumor cell (CTC)?

    Cancer is a disease that is characterized by the growth of abnormal cells, that if left unchecked would form a tumor. Cancer arises from a single mutated cells that grow and form a tumor where the original cell was, a so-called primary tumor. From the primary tumor individual cells can subsequently spread through the lymphatic system or blood circulation to distant parts of the body, sometimes forming metastases. Such spreading cells in the blood are called circulating tumor cells (CTCs).

  • What kind of information can I get from a CTC-test?

    To start with, you get a positive or negative test result for CTCs. A negative result means you probably have no cancer cells in your body. A positive CTC-result, on the other hand, means that there are one or more tumor cells circulating in the blood. You should therefore consider a thorough cancer evaluation in consultation with your physician. (Read more under “What a positive test result means” below.)

    By sequencing the DNA (i.e. examining the genetic information) from the cancer cells in the blood sample, iCellate can provide a list of known oncogenic variants, i.e. the mutations that drive the cancer. This information can help establish a diagnosis and suggest individualized treatments options. In addition, the test can help locate the primary tumor, in cases where it is not already known.

    DNA sequencing is also a useful tool in identifying hereditary diseases. Learn more about hereditary cancer under ”Inherited cancer risk” below.

     

    Till att börja med får du ett positivt eller negativt celltestresultat. Ett negativt resultat betyder att du sannolikt inte har några cancerceller i kroppen. Ett positivt CTC-test däremot innebär att det finns en eller flera tumörceller som cirkulerar i blodet. Detta resultat innebär att du bör överväga en grundlig cancerutredning i samråd med din behandlande läkare. (Läs mer under Vad innebär ett positivt test nedan.)

    Genom att sekvensera DNA (ta reda på den genetiska informationen i cellerna) från cellerna i provet, kan vi tillhandahålla en lista över kända onkogena varianter, d.v.s. mutationerna som driver den primära tumören. Denna information kan bidra till att fastställa diagnos och kan hjälpa till att föreslå individanpassade behandlingar. Dessutom kan testet hjälpa till att lokalisera den primära tumören, i de fall där den inte redan är känd.

    DNA-sekvensering är också mycket viktigt för att identifiera ärftliga sjukdomar. Lär mer om det under Riskprofilering nedan.

  • Why is it important to detect cancer at an early stage?

    Cancer that is detected at an early stage generally has a better chance of being treated. For some cancers, such as cervical, breast, colon and rectal cancers, regular screening tests are already carried out on risk groups. It is important to realize that early detection is only valuable if it leads to rapid diagnostic follow-up and effective treatment.

  • What does a negative CTC-test mean and what do I do with the information?

    A negative CTC-test shows that you most likely don’t have any CTCs in your blood, nor do you have a tumor. You therefore continue to be the same symptom-free, healthy person with low, average or high risk of cancer as you were before the test.

    You should continue with health-promoting activities and avoid risk-behaviors or -exposures that cause increased risk of cancer. You should continue with screening or early detection tests that fit your individual risk profile. Individuals with a family history of cancer have an increased risk of being diagnosed with cancer and should therefore be screened more often than individuals without cancer in their family history (see “Inherited cancer risk” below). Increasing age is an important risk factor and should therefore also be factored in when deciding the appropriate individual screening frequency.

    Very few tests are 100 percent correct and this true for the CTC iCellate's test. There is always a risk that a CTC-test will show negative results despite the presence of tumor cells in the blood. There is a possibility that none of the actual tumor cells will be included in any of the three test tubes if they are very few, resulting in a negative test result. Read more about the accuracy of the test below under “Is iCellate's CTC-test always 100% correct?

  • What does a positive CTC-test mean and who do I turn to?

    Ditt provsvar skickas alltid till den läkare som beställde provet och hon eller han kommer att hjälpa dig att tolka svaret och använda informationen på rätt sätt.
    Ett positivt CTC-svar innebär att du har cirkulerande celler i blodbanan som inte hör hemma där. Detta innebär troligen - men inte nödvändigtvis - en cancerdiagnos. Inom sjukvården används CTC-testet aldrig som enda test för att ställa diagnos. Information från redan etablerade metoder måste vara samstämmig med CTC-testet för att en definitiv diagnos ska ställas.

    Ett positivt CTC-svar betyder dock att det finns goda skäl till ytterligare undersökning för att fastställa vilken som är den bästa behandlingen i det stadium som den eventuella cancern befinner sig i.

  • Is iCellate's CTC test always 100% accurate?

    No clinical test is 100 percent accurate in all cases and iCellate's CTC test is no exception. It might be possible that you have very few CTCs in your blood even though there actually is a tumor to detect. This, in turn, could result in the fact that no tumor cells are present in the test tubes, although there are cells in circulation. The test would then show a negative result for CTC because there was nothing in the blood sample to detect.

    The risk of this happening cannot be ruled out, but the risk is significantly reduced by repeating the test at regular intervals. In addition, iCellate has shown a yield (sensitivity) of 90 percent, which means that if there is only one tumor cell in the blood sample, the probability of finding this cell is 90 percent.

  • What is the risk of false positive and false negative test results?

    • False positive means that the test shows positive for cancer while in reality there is no cancer in the body.
    • False negative means that the test shows negative for cancer even though there are in reality cancer cells in the body.

    The risk of false positive test results is very, very small. All positive cell tests are sequenced which means that the cells are analyzed at the DNA level. Sequencing investigates which genes are mutated (defective) and which of these are known oncogenic variants. Furthermore, it is determined which treatments can be proposed based on the scientific literature related to each individual oncogenic variant.

    However, the risk of false negatives is not negligible. If there are only a few circulating tumor cells in the blood, their distribution may be uneven. Despite taking several blood tubes, there is a risk that none of the few cells will enter the 20-30 ml of blood taken from the total blood volume of about 5 liters. The risk of false negative test results can be mitigated over time by taking CTC tests at the frequency that matches your particular risk profile. Once the tumor fragments are later discovered, it is still much earlier in the course of the disease than what is possible to detect with established diagnostic methods.

     

  • Do I have to take a CTC test if I prefer not to know as long as I'm feeling well?

    A CTC test for cancer does not fit everyone and you obviously have the right to refuse if a doctor suggests a test. You must be prepared for the result if it turns out positive and feel ready to take the necessary next steps that a positive test result entails.

    Of course, a positive CTC test result is an emotional strain. It is also in the nature of the test that the answer can be positive without cancer being confirmed by more established examination methods, which can increase the emotional burden. It is always best to consult your doctor to make an informed decision about the next step. (See below under "CTC was found in my blood sample, but no primary tumor could be identified. How can that be?").

    Not taking the test may allow you to feel better for the time being, but at the same time reduce your chances of early cancer detection. Should there be cell abnormalities, you will increase your chances of long-term recovery if you take the test regularly.

    Once a cancer begins to give symptoms, it has usually been developed for a long time, sometimes for many years. At a later stage in the course of the disease, cancer is often much more difficult to treat, sometimes even impossible, than if it is detected early. These are facts that should be taken into consideration when deciding whether or not to take an offered CTC test.

    Making healthcare decisions is an individual right, but it might be appropriate to also factor in those who are affected by your healthcare decisions, such as family and friends. Sometimes it may be wise to undergo a test not only for your own sake, but also for people who are close to you and who might be worried.

  • CTC was present in the blood sample, but no primary tumor was found. How can that be?

    The CTC test may be accurate even though no primary tumor can be found. The primary tumor may be too small to be detected by established clinical methods, including medical imaging. The tumor may continue to grow and may be detected only later. In cases like this, the CTC test has provided information on the very early tumor development. An individual follow-up plan should then be considered for further investigation and testing.

  • Why are CTCs sometimes missing in some people with confirmed cancer?

    The reason may be that the patient has received some type of effective treatment (radiation, surgery, chemotherapy) that has reduced the number of CTCs in the blood to below the limit of detection or completely eliminated them. It is therefore important to take the test only when the patient is not affected by medical procedures or treatments. See also the answer above under the section on "False negative test results".

  • Is iCellate's CTC test CE-marked?

    iCellate's CTC-test is performed in its own molecular diagnostic laboratory and uses the CE-marked IsoPic™ instrument. The test itself is not CE marked and is not required to be. The company iCellate is a registered healthcare provider that complies with patient safety legislation and is under the supervision of the Health and Social Care Inspectorate (IVO), a government agency responsible for supervising healthcare organizations.

    CTC analysis is an investigational method that is already thoroughly tested and quality assured in a laboratory setting. In order to quantify its real-world validity and utility, it is currently used in parallel with established methods and the results are weighed against those clinical best practices. The results are scientifically evaluated in order to offer the test to more patients faster.

  • Should everyone take a CTC-test just to be on the safe side?

    Not necessarily, a CTC testing decision is an individual right. One factor to consider is one’s objective risk profile including e.g. age, work environment, lifestyle, genetics or other pre-existing conditions.

  • Will iCellate's tests replace other cancer screening tests (such as mammography or PSA)?

    There is optimism that testing directly for the early spread of cancer cells should be able to replace other more indirect testing methods, but that still needs to be determined. It is too early to say which method(s) will be most effective in practical, medical and economic terms. Our hope is that CTC testing will be able to contribute importantly to complementing and improving today's screening methods.

    A vision would be to use CTC screening during the most relevant periods of one’s life, i.e. when the risk is the highest. In addition, if you could initiate early targeted treatment you should be able start managing cancers at an early stage with the commensurate hope of more effective cures. We are working to be an important part of that solution.

Inherited cancer risk

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  • What does inherited cancer risk mean?

    Do you belong to a "cancer family "? Have you worked with substances that were later found to be carcinogenic? Do you often worry about your risk of cancer? Different individuals have different risk of developing cancer. The degree of risk is influenced partly by age, lifestyle, other pre-disposing health conditions such as infections, the environment, and by inherited pre-disposing genes found in your gDNA (germ line DNA).

    The purpose of risk profiling is to compile the overall risk of developing cancer based on a comprehensive assessment of these factors in order to provide information of how to prevent going from being at risk to having overt disease.

    iCellate's contribution to risk profiling involves evaluating the inherited genetic risk factors, i.e. your inherited pre-disposition to cancer.

  • Is it possible to find out my personal risk of developing cancer?

    It is good to know your individual risk factors for cancer since that information can be used to effectively preventive the disease.

    Several cancers have in part known causes such as specific environmental exposures or lifestyle decisions that could be avoided. Examples of such causality are smoking and lung cancer, sun exposure and skin cancer, human papillomavirus (HPV) infection and cervical cancer, and Helicobacter pylori (H pylori) infection and stomach cancer. Overall infections cause about 15-20 percent of all cancers. Smoking causes another about 25-30 percent of all cancers. Diet can prevent or cause cancer. Natural errors in DNA replication during the life cycle of the cells cause about 10-30 percent of all cancers. The hereditary risk is estimated to be about 5-10 percent of all cancers and higher for some diagnoses (breast, prostate and colon).

  • How does an inherited cancer risk-test work?

    With a blood or saliva test, you can have your own gDNA sampled without even a need for a blood draw. The gDNA (germline DNA) test should be used to determine if you have any of the known genetic mutations that would give you an increased risk of developing cancer (so called oncogenic mutations). As new hereditary cancer risk variants are increasingly discovered, your existing gDNA sequence should be archived and re-examined later in life, in light of later scientific discoveries with in fact no gain from re-sampling or re-sequencing the gDNA. The gDNA sampling and sequencing therefore only needs to be done once during a lifetime, because the genome does not change. The existing DNA sequence file is just re-examined using new bioinformatic information and techniques. Only whole genome-type tests are amenable to this sort of re-examination. If the data set was reduced in the beginning to only specific genes, in order to cut initial cost for example, the re-examination will be limited to only those genes, providing a less than complete picture. If only a subset of genes were sequenced, it would be advisable to go back and re-test the entire genome.

  • What if I have a genetically elevated risk of developing cancer?

    If it turns out that you have an oncogenic mutation in your inherited genes, it means that you have an increased risk of developing cancer. Each known oncogenic mutation has its own risk of developing a specific type of cancer or different types of cancer during a lifetime. Sometimes the risk can be mitigated by the surgical removal of a particular organ, while others may not be helped by such an alternative.

    Since there is no way to predict when cancer will develop, it is important to tailor an individual cancer screening plan to increase the life and quality of life of the individual (see Cancer Screening above).

Genetic cancer evaluation

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  • What is a genetic cancer evaluation?

    Following a cancer diagnosis of any type, one needs to find out what type of cancer it is and what treatment is the most effective against that particular type of cancer. A genetic cancer evaluation is a test that accurately determines exactly what mutations are involved, what threat they pose and how it should be treated, as a complement to the general health care.

  • When is iCellate's genetic cancer evaluation suitable to use?

    iCellate's genetic cancer evaluation is suitable for patients with a confirmed cancer diagnosis. If the test is taken early, preferably as close to the detection of CTC and/or tumor as possible, the results can be used to guide the treatment selection process. If the test is taken late, the chances are that the utility of the results will be significantly lower and some treatments may have become irrelevant.

  • What information can my doctor get from iCellate's genetic cancer evaluation?

    iCellate's genetic cancer evaluation analyzes tumor derivatives (circulating tumor DNA, ctDNA) in the blood at a genetic level. This is done using Next Generation Sequencing (NGS). With the sequencing information, your physician will receive an in-depth view of the mutations of the tumor. The analysis of the genetic mutations should contribute to rational treatment decisions.

    The test may not always provide useful information for example if there are no targeted treatments that match the patient’s genotype.

  • Why do I need to ask my treating physician to order the test?

    Your doctor has by far the best knowledge of your particular condition and which tests are appropriate to best diagnose and plan your care and treatment.

    iCellate's genetic cancer evaluation is suitable for many, but not all. Above all, it benefits patients who have a difficult-to-interpret diagnosis and where a genetic test can help find alternative treatments. Therefore, iCellate recommends that you primarily consult with your treating physician if you are interested in taking our test.

  • Why would my doctor advise against taking iCellate’s genetic tests?

    Your treating physician will know if you seem to belong to a group of patients that would be expected to respond well to an established treatment. If that turns out to hold true there is little reason to make additional, and perhaps costly, tests.

    In some specific cases the cancer does not behave as an “average” cancer would be expected to. For such highly individual cancers, or if there is no established cure at all, a genetic test would provide the treating physician the exact fingerprint of the individual cancer. This individual genetic information on the cancer provides individualized guidance for the treatment.

  • How do I contact iCellate with questions or discussion about collaborations?

    Whether you represent a patient association, are a practicing physicians, are interested in the research behind our products and services or have other questions and concerns, you are always very welcome to contact us.

    - Christer Ericsson, Chief Scientific Officer, christer.ericsson(a)icellate.se

    - Iohn Ryott, VP Sales & Marketing, iohn.ryott(a)icellate.se

    You are also welcome to visit us at icellate.se.