BioCurex Business

Our RECAF technology has possibilities in a wide variety of applications in the fields of human and veterinary medicine. Our strategy is to continue to focus on obtaining non-exclusive licensing agreements for various applications of our RECAF technology while developing other applications internally. Specifically, with the net proceeds of this offering we intend to pursue the following:

grant one additional semi-exclusive license for testing blood samples using automated testing equipment;

commercialize veterinary applications of RECAF testing technology not requiring regulatory approvals;

finalize development of a POC rapid format test for the doctor’s office and bedside use;

conduct clinical trials and seek FDA approval for marketing a POC rapid format test; and

commercialize manual testing formats, principally in large cities in foreign countries where further regulatory clearance is not required.

To date our primary business strategy has been to license our Serum-RECAF technology under semi-exclusive limited license agreements. With this strategy, instead of having to allocate all of our funding in an attempt to commercialize one product, we select Licensees that have strategic advantages over the Company when it comes to commercialization (e.g., our licenses with Abbott and Inverness). As part of this strategy, we provide all of the assistance that we can to our Licensees; however, Licensees retain responsibility for obtaining regulatory approvals and bringing the products to market. Under our existing semi-exclusive licenses with Abbott and Inverness, we have retained the right to grant one additional semi-exclusive license for Serum-RECAF. These licenses cover only the automated testing format for Serum-RECAF in clinical and hospital laboratory settings. Additionally, they cover the use of Serum-RECAF in connection with other test formats and other applications of our technology on a non-exclusive basis.

Market distribution channels for a diagnostic test kit typically entail accessing the automated diagnostic platforms of one or more of the larger diagnostic companies, such as Abbott, Siemens, Beckman-Coulter, Roche Diagnostics and others. These companies provide automated diagnostic instruments that are capable of processing a variety of laboratory tests. Some instruments can process 1,200 clinical chemistry and 200 immunoassay tests each hour. Through licensing, we seek to place our cancer assays, such as Serum-RECAF, on the instrument menu of these diagnostic platforms.

We anticipate that a POC rapid cancer test could be used in the future as easily and as routinely as a blood sugar or cholesterol reading is now included as part of the general blood test protocol. 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. 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.

We recently presented preliminary results with our prototype rapid test to an international cancer congress. Data indicated solid discrimination between cancer and healthy cells and correlated with results using our Serum-RECAF assay. With the N.N. Blokhin Cancer Research Center in Moscow, Russia, we studied RECAF as a rapid test for cancer detection. Results found that RECAF could detect 80.4% of ovarian cancers in Stages I to III with an 88% specificity. This study tested 64 normal, non-cancerous samples and 51 ovarian cancer serum samples, which included 25 Stage I or II cancers and 26 Stage III cancers. We believe that these results signify a potential breakthrough that could simplify cancer detection. When applied to early stage ovarian cancer, our prototype POC demonstrated better performance than a CA-125 blood test, a tumor marker often found in higher-than-normal amounts in the blood of women with ovarian cancer.

We believe that a POC test will not cannibalize our clinical laboratory market since POC tests are routinely confirmed by (slightly more accurate) clinical laboratory tests. We believe that the widespread use of POC RECAF tests will actually promote the use of the clinical laboratory RECAF tests.

We estimate that there are approximately 250,000 physicians in the United States who would use these POC tests.

We do not plan to build our own sales force for any of our RECAF formats for human use. Sales and marketing for our automated laboratory testing format will be done primarily by our Licensees. Manual laboratory test kits and materials will be marketed by our partner laboratories. Once we have achieved FDA clearance in the United States for our POC rapid test, we plan to contract with medical device distributors and/or a contract sales force for marketing and sales.