BUSINESS (continuation)
Our Technology
We believe that our RECAF technology offers an improved detection, diagnostic, and monitoring solution for patients with cancer.
The RECAF Cancer Marker
Based on our research, which has been confirmed by Abbott and jointly presented at an international cancer conference, RECAF appears to be a cancer marker for multiple types of cancer. Every cancerous tissue that we have tested has expressed RECAF. It is expressed on over 90% of cancer samples that we have studied thus far, including breast, lung, stomach, colon, ovarian and prostate cancer samples. To our knowledge, there is no other cancer marker that has the same universal presence as RECAF. As such, we believe that RECAF could replace many currently available cancer markers that are targeted to only one type of cancer, as well as offer a useful diagnostic tool for cancers where there is not yet thought to be an effective marker, such as lung and breast cancer.
The chart depicted below is based on our analysis of human clinical samples of Serum-RECAF tests from subjects without cancer and from patients with diagnosed cancers or benign conditions related to cancer diagnosis. Each symbol in the chart represents the analysis of a patient’s blood sample measured by our RECAF test as expressed in RECAF units on the left vertical axis. Symbols above the horizontal lines indicate the presence of cancer at either a 95% or 99% confidence level. Symbols below the vertical lines indicate normal levels of RECAF and therefore indicate that the patient does not have cancer. Samples from non cancer patients that appear above the horizontal cutoff lines would be false positives. Samples from cancer patients that appear below the horizontal cutoff lines would be false negatives or patients with cancer that are missed by the test. Overall these data indicate a very low level of false positive results (specificity) and a very high level of reliability of detecting cancer in cancer patients (sensitivity).
RECAF is a molecule that is present on cancer cells but is not detected in significant levels on healthy cells or benign tumor cells. This characteristic enables RECAF to more accurately detect cancer than many current tumor markers, as RECAF is less likely to report a false positive result.
RECAF is a receptor for AFP (Alpha-fetoprotein) which is a marker for liver and testicular cancer that was discovered in 1963 by Dr. Garri Abelev, a member of our scientific advisory board. RECAF is present on the cell surface and binds and takes up circulating AFP. Both AFP and RECAF first emerge in the fetus, but disappear by birth. AFP binds small molecules, such as lipids, and transports them into fetal cells when taken up by the receptor for AFP. Once a fetal organ or tissue reaches its maturity, it no longer takes up AFP or expresses RECAF. After birth, RECAF is only known to exist in a cancerous state, where tissues re-express the ability to take up AFP via the RECAF receptor. The expression of RECAF is related to rapid tissue growth, which is characteristic of both cancer and fetal development. RECAF is classified as an oncofetal antigen due to its presence on both fetal tissues that incorporate AFP and on malignant tissues in later life.
We believe that RECAF has potential as a universal cancer marker for the following reasons:
- Current serum markers are deficient in terms of sensitivity and specificity, creating a need for enhanced markers.
- Current markers for breast and lung cancers (one of the most fatal cancers) are not very accurate and therefore not widely used. These types of cancers are among the best detected by RECAF.
- Routine RECAF testing after cancer therapy may be able to detect recurrence earlier and more economically than other technologies in current use. We believe that having one cancer marker to monitor all patients is a great advantage for the clinical laboratory
RECAF Product Formats
There are three basic formats for the RECAF technology: (i) automated testing in large clinical and hospital laboratories; (ii) non-automated, or manual testing by clinicians in smaller laboratory settings and where expensive automated instrumentation is not available or not practical; and (iii) point-of- care (“POC”), rapid test formats for physicians’ offices, urgent care facilities, or the bedside. These formats may be used to detect cancer in patients and for veterinarian use.
Automated Format
Our initial business strategy was to license the automated testing format on a semi-exclusive basis to three licensees. We have granted two of the three semi-exclusive licenses for this testing format–one to Abbott and one to Inverness. Under the agreements with Abbott and Inverness, we are allowed to grant one more semi-exclusive license for the automated format.
In early 2007, we completed the conversion of our blood based Serum-RECAF test to colorimetric format (“flash chemiluminescence”) to make it more practical for laboratory use required by our licensees and to improve sensitivity. This format improves detection of smaller, earlier stage tumors and magnifies the measured difference in RECAF serum values between cancer and normal patients. The test results found that RECAF had 80% to 90% sensitivity for a variety of cancers, with 95% specificity for lung, breast, stomach and ovarian cancers in particular.
Manual Format
We have developed prototype RECAF test kits and materials for small laboratories where automated instrumentation is not available or inpractical. These manual formats have the same sensitivity and specificity as the formats that use automated instrumentation. We plan to finish development of these kits and to place them in a few laboratories in major metropolitan cities in China, India and Mexico where those laboratories can market and run the RECAF tests without further government regulatory requirements.
To initiate this, we have formed a wholly owned subsidiary in China. The subsidiary, named “Biocurex China Co., Ltd.” will be used to assemble, market, and distribute our RECAF tests in China. The critical reagents will be shipped from North America for quality control purposes. Our first market is Shanghai, where we are represented by a clinical oncologist who will collect the samples and administer the tests in-house. Once we are operational in Shanghai, we will expand to other large population centers in China such as Beijing and Tianjin. If the model is successful, we then plan to replicate it in other countries in Asia, Latin America and Eastern Europe.
In the United States, once the FDA has approved the automated testing format, we will be able to apply for 510k approval for the manual testing format on an expedited basis.
Point-of-Care, Rapid Test
As another segment of our current strategy, we have developed a prototype blood-based POC rapid test for cancer detection or follow-up in physicians’ offices and urgent care facilities. This format may also be useful in third-world countries or areas with large rural populations where access to even small clinical laboratories is not available.
Our POC rapid test device, a rendering of which appears below, will be similar to a common pregnancy test kit. The rapid test cartridge will contain a small strip that is coated with the indicator molecules to detect RECAF in a blood sample. These types of tests are used for a variety of applications in diagnostic medicine, and they can be efficiently developed from the prototype data that we currently have. We intend to contract with an experienced developer of POC tests to fully develop our POC rapid test.
We anticipate that our POC rapid test will require the development of a small, portable instrument to read the intensity of the colorimetric endpoint line in order to alleviate the variability of eye measurements. We will likely need to eliminate operator variability to be eligible for certain medical reimbursements.
When a patient enters a physician’s office with a specific symptom or concern where cancer is suspected, the physician could administer the rapid test to receive a preliminary indication as to the presence of elevated RECAF levels in the blood. We anticipate that such a cancer test could be used as easily and as routinely as a blood sugar or cholesterol reading is now used as part of the standard blood work. The more detailed Serum-RECAF laboratory test would be used to confirm the rapid test result as is common now for most of the rapid tests used in the infectious disease setting.
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