The paper, "A Simple Screening Test for Cancer", was published April 2021, in the medical journal- Advances in Cancer Research and Clinical Imaging. To read the paper please click on the link below:
With 600,000 annual deaths, cancer is a leading cause of mortality in the US, 2nd only to heart disease, which claims 650,000 annually. Early-stage cancer patients typically have no symptoms and so often they are unaware that a cancer already exists and maybe spreading.
Finding cancer after it has already spread dramatically decreases the chance of survival. For example, estimates are that stage 1 colon cancer patients have a 95% chance to live 5 years, whereas those with stage 4 colon cancer, which means that the cancer has already metastasized or spread to other organs, have only a 5% chance of living 5 years.
A Long Overdue Solution
A challenge with current imaging screening tests such as CTs, mammograms and x-rays etc., is that tumors have to be a certain size to be found. As a result, a number of early-stage tumors are missed simply because they are small.
We have developed the 1st point-of-care cancer screening tests. The tests identify an altered sugar molecule that is only produced by precancerous tissues and cancers.
Identifying patients at risk at the earliest stages of cancer, even tissue at risk of becoming cancerous is the most significant benefit of this technology. Thousands of patients in multiple published clinical trials have typically shown an accuracy of 80 to 95%.
Note: Screening tests are not diagnostic tests. Rather, screening tests are used to alert doctors that asymptomatic patients are at an increased risk, and that further evaluation and testing may be needed. An example of a well-known screening test is the recent temperature checks taking place at airports to screen for Covid.
The Science Behind the Product:
For a decade, as transplant physicians harvested organs, Professor Shamsuddin, who was a pathologist with a specialty in colon cancer, collected healthy intestinal tissue for research. He compared this truly healthy tissue from organ donors, with similar looking and supposedly "healthy" tissue, found in other locations in the colon of colon cancer patients.
Once the tissue was stained, under the microscope, he noticed a very slight color variance between the intestinal mucus from the organ donors and those with cancer. Plus, the mucus from tumors was the same color as supposedly "healthy" intestinal tissue samples taken from various locations in the colon of these cancer patients.
Professor Shamsuddin then proposed the concept of the "Field Effect". Cancer causing agents (carcinogens) such as tobacco smoke come in contact with millions of lung cancer cells in the "field" and cause changes to these cells. The tobacco smoke impacts all these millions of cells, however usually only one or two cells convert and become cancerous.
Dr. Shamsuddin then set about to discover a way to not only identify cancer at the earliest stage, he sought a way to identify the tissue in the field that was not yet cancerous, but at an increased risk of converting to cancer.
In the mucus of cancer patients, he found an altered sugar molecule. This altered sugar was present in both the colonic tissue away from the tumor, as well in tumors. Most importantly, the altered sugar molecules were not present in the colonic mucus from the organ donors.
Once the Professor had identified this altered sugar, he then set out to invent a test that could identify the altered sugar. Once the test was found to be very accurate in the lab, a number of clinical studies around the world were started. The published trial results typically demonstrated an accuracy of 80 to 95%.
One of the colon cancer clinical trials was very intriguing, even after the colon cancers were removed from patients, several continued to test positive for the altered sugar. Within a year, a number of the patients that still tested positive, had a recurrence of their cancer. This trial clearly showed that the test identified tissue at risk of converting to cancer, which is the ultimate goal- find it early! This clinical trial also showed the potential of being used to monitor patients for cancer recurrence. See the COLON page of this website.
There have been more than 20 published peer-reviewed clinical trials with more than 10,000 patients. The majority of the clinical trials have been conducted on colon cancer, as the pathology Professor was a colon cancer specialist. The clinical trials conducted with lung and breast cancer patients also showed a similar accuracy, and most importantly, the test identified early-stage cancers.
When a cancer is discovered before it has spread, often the tumor can be removed, thus leaving the patient cancer free.
20% or 4 million of diagnosed are nonsmokers
28000+ of the 2019 deaths are non-smokers
142,670 estimated deaths in the US in 2019
Smokers and non-smokers, we're all at risk!
There is no standard screening test for lung cancer! Chest CT exams are costly and emit a lot of radiation.
41,760 estimated deaths in the US in 2019
Physical breast exams and mammograms may miss up to 40% of early stage breast tumors.
There is a critical need for a safe, accurate early stage breast cancer screening test.
51,020 estimated deaths in the US in 2019
Standard screening for blood in the stool can miss early stage tumors, as they may not yet be bleeding. New blood & DNA screening is more accurate, however much more expensive.
No longer will patients have to collect their stool and send it to the lab. This screening test can be completed in 15 minutes by the physician and/or office staff.
31,620 estimated deaths in the US in 2019
Current screening test is the PSA Test, which has limited predictive value, as the PSA test does not effectively differentiate between an enlarged prostate (BPH) versus a cancerous prostate.
Many senior men worry about this, as they are unsure if frequent or nighttime urination is due to cancer or an enlarged prostate.