Important News the ‘Today Show’ Missed

It was promoted as the controversial test that saved Ben Stiller’s life @RedHourBen on the Today Show[i] during @NoShaveToday, and ended with the pronouncement “Every guy should get tested.” Of course they were talking about the PSA test that many medical and government officials have suggested be done away with due to lack of accuracy and suspected over-treatment issues. And while I totally agree that every man should start with at least a PSA, and it is clear Ben’s simple and easy PSA test put him on the path that saved his life, the ‘real news’ should have been that there are FOUR (4) far more accurate, equally simple new tests, than the PSA that we are failing to employ due to political and financial pressures. And because we are remiss in employing these new tests, men are needlessly dying or being put at greater risk from prostate cancer.

Why these tests are not now the tests of choice in the US is beyond me. One of these new tests has been used in Europe since 2009 and Australia with exceptional results, and has been approved for use in the U.S. since June of 2012. Unfortunately it may be years before this test becomes commonplace as it is still unknown by many physicians or even covered by insurance. How sad, but so typical.

This first test is called the Pro-PSA in Europe and the Prostate Health Index test (PHI Test) in the U.S. It is a simple blood test that combines three markers: PSA, percent free (or free PSA), and a precursor form of PSA called -2proPSA (also termed Pro-PSA or p2PSA). As a precursor to PSA, there is evidence that Pro-PSA is 2.5 times better connected to prostate cancer than say BPH.[ii] Results of these three markers are then run through a sophisticated algorithm to determine the probability prostate cancer exists. Research has shown the PHI process to be Three Times Better overall at predicting prostate cancer than standard PSA tests for men in the 4.0 ng/ml to 10.0 ng/ml range. Test results are provided in PHI ranges with the higher scores more indicative of cancer. Scores from 0 to 24.0 suggest an 11% of cancer where highest scores greater than 55 have a 52.1% of cancer.[iii] Since the PHI test has so out-performed the previous combination results of PSA and percent free, where used, it has greatly reduced unnecessary biopsies while better detecting more aggressive prostate cancer.

If you are considering testing for prostate concerns it seems only appropriate to ask your doctor for the PHI test whenever available. The lab currently doing the PHI test in the U.S. is ACCU Reference Laboratory. You, or your doctor, can call direct and contact Vanessa there at 908-474-1004 ext:145. Explain you would like a PHI Test Kit sent to you (or to the doctor) and they will send out a kit with information brochure and test instructions for 'free'.

Next you need a doctor to order the test. This could come from any primary care or urologist and may be covered by insurance. Once samples are taken they are sent back to ACCU and they have a 24-hour turn around time for results that they send directly to your doctor. Your doctor’s office can put in the insurance claim for the test. If it is NOT covered by insurance the test cost should be billed at $110 from ACCU. There will also be blood draw and FedEx shipping costs.

The second improved prostate test is the 4KScore Test.[iv] This test provides a much better look at the possibility of having Aggressive Prostate Cancer, claiming 94% accuracy in this area. Certainly an important consideration to determine if a biopsy could be necessary. Based on 10 years of research by Memorial Sloan Kettering Cancer Center, the test takes into account the patient’s age, any previously negative biopsies, if there are any nodules discovered during the DRE, total PSA, free PSA, intact PSA, and measures the amount of hK2 protein in the blood. The protein hK2, also called human kallikrein-related peptide, is made largely in the prostate and responsible for cleavage of pPSA to mature PSA. Since PSA and hK2 express differently, they are considered independent markers. As a general test to determine if one has prostate cancer the original PSA test had an accuracy rate of roughly 55%. This was improved to 65% by adding information from the Free/Total PSA test. The PHI test results have improved prostate blood test accuracy approaching 75%. Now the 4KScore Test comes along and has been called the most accurate test to assess a patient’s risk for aggressive PCa prior to biopsy suggesting physicians could possibly reduce the need for unnecessary biopsies by 30 to 50 percent while still identifying high-grade treatment required cancers.

The third improved test is the SelectMDX.  The primary reason PSA is inaccurate is that PSA can vary widely for so many different causes other than prostate cancer. Prostate infections such as prostatitis, BPH, having sex, a doctor administered DRE, medications and supplements, even a long bicycle ride can cause your PSA to dramatically climb. This is why there are 750,000 unnecessary prostate biopsies done in the U.S. each and every year. Now the PHI and 4KScore tests are considerably more accurate because they take into account additional factors, but they still rely on PSA for part of their calculations and results. To avoid this PSA conundrum there now comes a new and possibly better prostate test.

It is a relatively more accurate version of the original PCA3 test. The important point to note is that the SelectMDX does not rely on PSA. Instead this test measures two distinct biomarkers in relation to cancer. From this you receive two different percentage numbers that include the likelihood you might have low-grade PCa, and the likelihood you might have high-grade PCa. The test uses a Urine sample directly after a DRE. Doctors can order the test kit from the company in Irvine, CA http://mdxhealth.com/selectmdx-prostate-cancer and the test without insurance is billed at $500 but with 'prompt pay’ - within 30 days after billing, the cost is reduced to $200. Be sure to check with the MDX billing department for confirmation on this and to see if your insurance might work. Note: some insurance companies like Aetna have covered it in the past.

For all men with a widely varying PSA, I believe this would be an excellent test. Accuracy for determining lack of prostate cancer appears to be around 90% to 96%. Most likely you will need to find and talk with an informed ND or MD in your area to have the DRE and sample properly taken.

The fourth improved test is the ONCOblot. There is available today a new test capable of detecting 27 different types of cancer, and there organ of origin, with a single blood draw including: Prostate, Bladder, Breast, Cervical, Colorectal, Endometrial, Esophageal, Gastric, Hepatocellular, Kidney, Leukemia, Non-Small cell, Lung Small cell, Lymphoma, Melanoma, Mesothelioma, Multiple Myeloma, Myeloma, Ovarian, Pancreatic, Sarcoma,  Squamous Cell, Thyroid, Follicular, Uterine, Papillary, Testicular Germ Cell cancers. It accomplishes this by using the ENOX2 protein as a marker,[v] and then determining its molecular weight and isoelectric point. The test, though not infallible, claims a 99.3% reliability for determining cancer(s) with no false positives, and 96% accuracy in determining the type of, and organ site, of the cancer.[vi] Certainly better results than the original PSA test. This ONCOblot test has been called, “the most sensitive blood test for cancer available today”. Unfortunately it can’t determine the stage of the cancer, the amount of the cancer load, or any cancer spread. It just effectively tells you if you have cancer, or not. Yet when considering whether to have a biopsy, determining if you have the real possibility of cancer beforehand is incredibly valuable knowledge. Currently, the ONCOblot test is approved by the FDA as a ‘Laboratory Developed Test’. Unfortunately, it is not covered by insurance, as it is too new, and little known by many oncologists. It was first made available to the public January 2013.

Using this test as a follow-up to the standard PSA test that so often triggers a biopsy, could save the American public and insurance companies over $2 Billion per year by dramatically reducing the 750,000 unnecessary negative prostate biopsies. But the real benefit may come from the millions of lives it could save. You see this test can find cancer even before major symptoms appear. It detects cancer with as few as 2 million cells, unlike current mammogram scans that need 4.5 trillion cells to register.

If these 4 tests were covered by insurance today, we could save the U.S. billions of wasted medical dollars in unnecessary medical procedures, and more importantly hundreds of thousands of lives each year through more accurate and earlier cancer detection and appropriate treatment. This should be the real news story. Why we are failing to employ these tests when there is so much to gain from their use, and why we allow 500,000 U.S. citizens to die of cancer each and every year without doing everything possible to save their lives.

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[i] http://www.today.com/health/ben-stiller-opens-first-time-revealing-cancer-diagnosis-t105232

[ii] http://www.myinnovativelab.com/prostate.html

[iii] http://www.ncbi.nlm.nih.gov/pubmed/23375961

[iv] http://clinical.opko.com/how-does-4kscore-test-work

[v] http://www.oncoblotlabs.com//wp-content/uploads/2013/04/Cancer%20prevention.pdf

[vi] http://www.oncoblotlabs.com/how-it-works/