The IvyGene Lab Test: The Future of Cancer Testing

Dr. Kevin Conners

One of the most common questions we hear from our cancer patients is, “How will I know I’m improving”? Many were diagnosed with cancer through traditional screening methods and now that they’ve chosen to pursue alternative care they often don’t want to be re-screened through those same methods. In the past, I’ve told patients that the only way to know with the most certainty is to “compare apples to apples”. For example, if a patient did a CT Scan and it showed the size of the pancreatic cancer was 2.6cm, the only way to know if that specific test result has changed is to have another CT Scan. The same goes for a PET Scan, an MRI, etc.

However, these traditional “gold standard” testing modalities are not perfect. There is no test out there that is an exact science, no matter who tells you how effective or accurate it is. The greater problem is that a lot of these traditional tests are highly invasive and can potentially be a source of physical harm. It’s no secret that an abdominal CT Scan has the same Radiation dose of about 50 x-rays, which is cancer causing in itself. So if a doctor’s first role is to ‘do no harm’, finding a non-invasive test for diagnosing cancer and monitoring its progress is imperative.

Non-invasive assessment – up until now – have required doctors to resort to symptom monitoring or testing with methods like applied kinesiology. For clinics or patients who just want a general gauge of how they’re doing, there is nothing wrong with using these options but they are not objective, researched, and lack reproducibility. But with the advent of the new lab test, which tests for DNA sequencing, non-invasive cancer tracking has been provided a complete game-changer. In fact, in the coming years this lab test is anticipated to take the place of biopsies for many cancers. The lab is called IvyGene and the results from testing DNA sequencing are so specific that it actually provides a quantitative gauge to whether a patient’s cancer is improving or progressing. Allow me to explain further what DNA Sequencing is.

If you have a basic understanding of genetic testing and methylation, you’ll understand that your body has two main goals in life: to make ATP (energy for cell function) and to make Methyl Groups. Methyl Groups are important because they turn genes “on” and “off” (we’re not talking about genetic defects, we’re talking about genes doing their work). Genes have to be turned on to work, and they can be turned off through being methylated. Methylating a gene sequence is how genes are turned off so proteins aren’t created – something necessary to maintain the perfect balance of every metabolic function.

When looking at specific genes that may indicate a growing cancer, typically we focus on tumor suppressor genes (genes that turn cancer off) and tumor oncogenes (genes that can turn cancer on). A normal cell will have both methylated and unmethylated CpG Islands at certain points. Tumor oncogenes should be ‘turned off’ and tumor suppressor genes should be ‘turned on’. Essentially you could say that the tumor suppressor genes are ‘turned on’ when they are working (if a gene is unmethylated, it’s turned on). We want tumor suppressor genes turned on because we live in a toxic world, cells are becoming damaged and they’re replicating from one damaged state to another. This is when our tumor suppressor genes would kick on, cause those damaged cells need to go through apoptosis (programmed cell death) and prevent that patient from developing cancer. Cancer oncogenes, conversely, should be turned off or “methylated”.

In a cancer cell the opposite methylation expression is present. Cancer cells will have methylated tumor suppressor genes and unmethylated tumor oncogenes. To the degree that this is the case, the tumor suppressor genes cannot instruct the cell to kill the growing cancer. Therefore, cancer is a picture of both hyper and hypo methylation.

The benefit of the IvyGene test is twofold: 1) it can determine the presence of cancer for those not desiring a formal biopsy, and 2) it will give a quantitative score (an IvyGene score) that can be used as a marker of success in a given choice of care.

The IvyGene test is a diagnostic blood test from a CLIA approved lab. It has a turnaround of about 5-7 days and boasts results at about 92% certainty. The main steps involved in the blood test (as spelled-out by IvyGene) are as follows:

  • Whole blood – not spun – is collected and shipped to the laboratory.
  • Cirulating tumor DNA (ctDNA) is extracted from the sample.
  • A bisulfite conversion technique is employed to identify sites of DNA methylation (5-methylcytosine).
  • Target regions of the ctDNA are sequenced by using advanced DNA sequencing methods to detect DNA methylation sites.

Once the results are collected, a patient receives a numerical cancer score. If the patient ranges 0-9 on the score, there is little to no active cancer; if they had a previous diagnosis of cancer, one might say they are in a fairly healthy state of remission (but we’d caution you that things can change VERY suddenly). If the patient ranges 10-19, there may be some active cancer starting/continuing in the body but depending on the type of cancer previously diagnosed, this may also be considered as a relative state of remission. Of course, a score of 17-19 means one is at the “higher end” of that scale. Any score of 20 and above suggests active cancer, not in remission, and one may need to consult with a physician of choice to plan a protocol of care. If a patient has a score of 20 and above, the higher the score is equivalent to a higher degree of tumor burden. However, patients who’ve already had a confirmed diagnosis of cancer, a score of 20+ may be the likely starting point.

Understand that this test measures over 20 different cancers but has been extensively tested for colon, lung, breast, and liver cancer. This may mean that a score of 19 in a patient with no previous diagnosis of cancer should invoke the doctor to request further testing to investigate early cancer growth, while the same score of 19 in one previously diagnosed and treated for breast cancer may be fantastic news! Since your signs and symptoms, results of other testing, and your current diagnosis influence the interpretation of your score, the doctor will help you accurately interpret your test.

The wonderful part about this test is that a patient’s numerical cancer score will change depending upon whether the cancer is improving or worsening. If a patient has an initial high-risk cancer score of 65 and three months later their IvyGene score shows a high-risk score of 60, we know we’re going in the right direction. This is fantastic and means that for less than $500 we can accurately gauge whether or not our current therapies are working. This offers patients an objective, concrete answer to questions about progress, helps maintain feelings of peace that what they’re doing is effective, and gives us as a clinic a reliable means of tracking the efficacy of our protocols.

For those interested in IvyGene testing, call our office or visit our website – Conners Clinic – 651-739-1248. www.ConnersClinic.com