The sooner you find a tumor, the better your odds of beating it.
Lung cancer is by far the deadliest of the cancers largely because it is discovered most often in the later stages, as there is no standardized screening test for the lungs..
As seen on the drawing displayed on the "THE SCIENCE" page of this website, you can see there is a dramatic difference in survival depending on when a tumor is found.
When colon cancer is found at:
Stage 1 - 95% chance for 5 year survival
Stage 2- 70% chance for 5 year survival
Stage 3- 50% chance for 5 year survival
Stage 4- less than 5% chance for 5 year survival
These tests will greatly improve healthcare simply because they are able to detect changes in tissue at the earliest stage, often before actual tumors have even formed.
In the case of these 5 organs (lung, breast, prostate, uterus and colon), the cells all produce a sugar that is secreted and becomes part of the mucus in the area. For example, in the case of the lungs we are referring to the mucus from our lungs that ends up in our mouth, in the case of the colon we are referring to the mucus membrane that lines our colon and rectum.
The marker or the altered sugar we have referred to, is only produced by precancerous and cancerous cells and is not produced by our healthy cells. Cells produce a sugar and when healthy cells undergo DNA change, the sugar they produce can change also and it is this altered sugar that our test identifies.
Because precancerous tissue, such as a polyp in the colon, produce this altered sugar, we are able to detect tissue changes at the very earliest stage.
A great example is the first clinical trial presented on the lung page. 9 of 10 patients with lung cancer tested positive for the altered sugar marker. At the same time the test identified 15 patients believed to not have cancer. However on the follow up these patients were found to have lung cancer THE IMPORTANCE AND IMPLICATIONS OF THESE RESULTS CANNOT BE OVERSTATED!
People have not changed, and so our published, peer-reviewed clinical trial results are still very valid. That said, like any other technology, a cancer screening technology can become obsolete when a more accurate technology is discovered and tested.
We are unaware of any Imaging technique (CTs or mammograms etc.) that have been as accurate in detecting risk of early-stage tumors. This makes sense, because creating an accurate image is difficult when a mass is small, as is often the case with early-stage tumors.
Likewise, DNA and RNA screening technologies have challenges finding Stage 1 cancers. Due to the size of early-stage tumors, the amount of DNA or RNA fragments present in the blood is usually much less, thereby making detection that much harder.
For example, one of the leading DNA technologies called GRAIL found 39% of Stage 1 cancers. Another test called Thrive found 27.1% to 31.1% of cancers using DNA and protein markers in the blood. See the slide deck on the INVEST page for links to these study results.
In our testing to date, we have identified a far greater percentage of patients at risk of early-stage cancer. This makes sense, because even precancerous tissue produces the altered sugar marker that our test identifies, and thus there is a much larger amount of the marker present.
A simple analogy would be: looking for DNA in the blood is like looking for a needle in a haystack, whereas looking for the altered sugar marker is more like evaluating the composition of the haystack itself.
These tests are very safe and noninvasive. There is no radiation, as found with mammograms or CT scans. No blood is required and so there is no need for needles or a blood draw.
No, these tests will be very reasonably priced. The exact cost will not be available until we launch.
However that said, a 3 piece kit that will screen the lung, colon and breast for ladies or the lung, colon and prostate for men, will be a fraction of the cost of the current colon screen that checks for blood and DNA in the stool.
Basically we expect to screen 3 or 4 organs for a fraction of the cost to screen just the colon.
These tests have shown an accuracy or 80% or more. There are 2 components that make up accuracy- Sensitivity and Specificity.
Sensitivity refers to how effectively the test identifies the marker from a group of people. For example, if 10 people out of 100 people had the condition and the test found 9 of these people, the test would have a 90% sensitivity, as it revealed 9/10. Sensitivity is the most important of the 2 components, as we do not want to miss people that have cancer.
Specificity refers to the percentage of correct negative results when patients did not have the condition. In our example above, 90 of the 100 people did not have the condition. If 82 of these 90 correctly tested negative for the marker, then the specificity would be 91% or 82/90. The false positive % in this case would be 9%, as 8/90 people tested positive for the marker that did not have the condition.
The problem with a low specificity, which implies a high false positive rate, is that too many people being screened will go on to get unnecessary further diagnostic tests and evaluation. For example, the high false positive rate when checking for blood in the stool, which can be due to a number of things such as a bleeding ulcer or hemorrhoids etc., can result in unnecessary and expensive colonoscopies.
Note: Even though clinical tests have typically shown a false positive rate of less than 20%, these false positives may still offer useful information. See the question below, and how a high % of the 32 patients that had false positive results, went on to have a recurrence of their cancer - "False" was not really false!
Patients that have had a tumor removed, sometimes worry if the cancer will return, as they have a much higher risk of recurrence than those never having had the cancer.
Professor Shamsuddin invented these tests based on the "field-effect" theory he originated. The basis for the "field-effect" theory, was that he found molecules in what appeared to be "healthy" tissue from cancer patients, that were in fact the same molecules found in nearby tumors. However these molecules were not found in genuinely healthy tissue, which was obtained from the organ donors (see "The Science" page). He then invented the tests to look for these specific molecules, which in this case was an altered sugar molecule.
In the first of the 3 clinical trial abstracts found at the bottom section of the Colon page of this website, the paper describes a clinical trial in which 53 of the patients were followed after their tumor was removed. Despite having their tumor removed, 32 of these 53 or 60% of these patients still tested positive with our test.
The question then becomes- Were these 32 patients at an increase risk of recurrence because they still tested positive for the altered sugar molecule? Within 1 year, 16% or 5 of these 32 patients did have a recurrence. It is highly unlikely that 16% of healthy people would develop a tumor of the colon in 1 year.
At the same time, 21 patients that were retested after having their tumor removed no longer had the marker or tested negative. None of these 21 had a recurrence of their cancer after a year.
We expect that these tests will in time also be used to monitor patients and evaluate risk of recurrence.
Our screening test for breast evaluation is not painful or uncomfortable. Whereas for some women, especially those with dense and/or large breasts, mammograms are often painful, or at least uncomfortable, as the breasts must be compressed in order to get the best images.
Obtaining the mucus sample from the various organs takes a minute or two from each site.
Once the mucus or fluid samples are obtained for each organ, then the tests themselves take approximately 15 minutes for the reagents to work and get the results.
Patients can get the test results before they leave the office. This makes it much easier for physicians and their patients to determine if further evaluation and or testing is indicated, and then to schedule any follow up appointments or testing.
Cancer with approximately 600,000 deaths yearly is the 2nd leading cause of death in the US after heart disease and stroke, which claim approximately 650,000 lives.
These 5 cancers account for almost half of all US cancer deaths.
Based simply on an age of 35 or more, approximately half the population of 330 million or 165 million Americans should be screened.
Effective screening can reduce so much grief, suffering, pain and loss of life!
Here is a negative (no color) and a positive (pink/magenta) from one of the colon cancer trials. Results are easy to determine with the naked eye- no microscope or expensive equipment needed. No equipment together with fast results (15 min) is why these tests can easily be completed in an office and no lab is required.