Saliva from cancer patients and healthy donors was tested using a slightly modified RECAF chemiluminescence assay (the chemiluminescence format was chosen for practical reasons but in light of the results found, it is anticipated that the ELISA format will perform equally well).
A variety of malignancies were tested, including lung, breast and gastrointestinal cancers.
The results showed that the test can detect cancer with 87% sensitivity and 91% specificity (sensitivity is the percentage of cancer patients that are positive with the test and specificity is the percentage of healthy individuals that the test reports as negative).
While the number of samples is relatively small (15 cancer patients and 22 normal donors), the statistical significance is very high (p less than 0.00025). In medicine, the lower the value of p (probability due to chance), the more significant is the result. A p less than 0.05 is considered as significant and p less than 0.01 is considered as very significant.
Dr. Moro stated: "These results are extremely significant because it is much easier and less expensive to screen for cancer using saliva samples than serum samples. We believe we can trim the assay to work even better, but even at these levels we can lower the threshold above which we say a patient is positive for cancer, thus increasing the sensitivity to close to 100%. Then a serum test can be run on the saliva positive cases to eliminate many if not most of the potential false positives.
These results harmonize very well with the cancer screening initiatives developed by the Goshen Center for Cancer Care. Our two organizations are now coordinating future plans to extend these results in preparation to launching a pilot cancer screening program using the RECAF tests."
Dr. Kenneth Pennington, member of the oncology team at the Goshen Center for Cancer Care stated: "The ability to detect evidence of active cancer in saliva is very exciting when considering the potential for screening for common cancers such as breast and lung cancer. The current patients tested have evidence of widespread disease. It will be important to study the saliva of patients with early stage disease to see if these findings are present in early stages as well. These studies are currently being planned and will be active in the near future. If the previous findings are confirmed in early stage disease, then a new paradigm for screening for common cancers will exist."
Previous results obtained with serum samples have shown that the RECAF test can in fact detect early stages (Stage I and II) of prostate and breast cancer; where the curability is highest. These results have been presented at an international cancer congress (early stage detection of prostate cancers) and are the subject of two manuscripts in preparation to be submitted for publication in scientific journals.
About the Goshen Center for Cancer Care:
The Center for Cancer Care provides medical, radiation, nuclear and surgical oncology, as well as naturopathic medicine. The Center for Cancer Care uses advanced technology that placed in the hands of our doctors becomes even more effective. The Center's medical team works as an integrated team, carefully reviewing a patient's condition and needs to develop a plan that works best for the patient.
Wide ranging research is an important part of a cancer program. The Center for Cancer Care's ability to offer the latest treatment options is made possible by tirelessly searching for and securing quality research initiatives.
At this time, the Goshen Center for Cancer Care has over 40 clinical trials in progress.
For more information about The Goshen Center for Cancer Care click here.
For more details on the collaborations between BioCurex and click here.
About BioCurex:
BioCurex, Inc. is a biotechnology company that is developing products based on patented/proprietary technology in the areas of cancer diagnosis, imaging and therapy. The technology identifies a cancer marker known as RECAFtm, which is found on malignant cells from a variety of cancer types but is absent in most normal or benign cells.
BioCurex has signed licensing agreements for its cancer detection blood tests with Abbott Laboratories and with Inverness Medical Innovations (for further information on these agreements see: http://sec.gov/Archives/edgar/data/1092562/000100487808000117/sb2amnd4s1april08.txt).
The cancer marker RECAFTM has emerged as a potential biomarker that may be useful in the development of new cancer diagnostics tests. Preliminary studies from the investigators at BioCurex have reported a high level of clinical sensitivity and specificity for RECAF in many of the most common cancers, including prostate, breast, colorectal, lung and others.
CONTACT INFORMATION: BioCurex, Inc. Ricardo Moro (604) 207-9150 Website: www.biocurex.com
