Plans For Direct Commercialization Of ELISA RECAF Blood Tests For Cancer

BioCurex Inc. (OTCBB: BOCX – News): Following the completion of its successful testing on bladder, kidney, stomach and other types of cancer, BioCurex is pleased to announce that its ELISA technology can now move Biocurex towards early commercialization of its proprietary RECAF cancer-detection.

BioCurex had developed two previous formats of its RECAF blood tests for cancer – the tried-and-true radio-immunoassay (RIA), which was useful to demonstrate proof-of-concept, and chemoluminescence, which is used in many high throughput automated instruments. While each format filled its purpose, neither one allowed BioCurex to directly market its own tests. However, most clinical and research labs use ELISA technology on a daily basis and BioCurex has recently announced the successful development of its RECAF ELISA blood test for cancer.

As previously noted in Biocurex’s announcement of May 28, 2008, the ELISA testing was done in collaboration with the Blokhin Cancer Research Centre, in Moscow, Russia, and the results will likely be presented to an international cancer congress later this year.

Manual tests (e.g. not performed in automated instruments) are excluded from the semi-exclusive limitation of BioCurex licensing agreements. This fact, together with the Company’s development of the ubiquitous ELISA format, has prompted Biocurex to undertake the direct commercialization of its ELISA RECAF blood tests. It should be noted that Biocurex’s ‘manual’ ELISA tests can run at about 150 tests per day, per technician, and do not require the hefty investment in the automated instrument.

BioCurex has patents granted in several foreign countries such as China, Russia and Australia; and it has been recently granted a patent by the European Patent Office. This covers a significant amount of territory in which to launch the ELISA RECAF blood test.

In the coming months, Biocurex will attempt to market its ELISA tests to clinical laboratories in foreign countries:

‘ Each clinical lab will be responsible for obtaining approval from the regulatory agencies in its country. The regulatory approval process in many countries is generally considered to be less demanding than the US system. Further, regulatory approval is more easily gained in many countries if an accredited lab is manufacturing the test.

‘ The agreements with each of these clinical labs will require up front licensing payments and minimum sales quotas. Royalties will be paid to Biocurex as a fixed amount per test, or as a percentage of the revenue generated by RECAF in the clinical lab – depending upon how each agreement is negotiated.

‘ It is anticipated that most of these clinical labs will manufacture the tests in-house, using critical reagents supplied by BioCurex. This will ensure quality control of the final product, and enable BioCurex to track the number of units sold in each country.

‘ Our current and future semi-exclusive licensees’ ability to market their RECAF tests in the same country will remain unfettered. Conversely, these clinical laboratories will have the right to stop using manual tests and start buying RECAF tests directly from our semi-exclusive licensees for use in automated instruments. Either way, BioCurex will receive revenue from the sale of some type of RECAF test.

‘ In addition to its use in clinical labs for cancer detection, BioCurex will offer RECAF ELISA tests for research and investigational use worldwide. This should expedite validation of the technology and publication of results by independent laboratories.

The initiative to commercialize our manual ELISA tests overseas is already in place and we are currently discussing terms with interested parties in several countries. We are also preparing to start shipping critical reagents of finished tests for local regulatory approval in the coming months.

This development represents a turning point from a strictly research company. We are now able to add a revenue generating diagnostic cancer test to our continued scientific developmental work.

It should be stressed that this initiative does not contradict our strategy to license the RECAF blood tests (chemoluminescence format) to large diagnostic companies; they hold the lion’s share of the diagnostic market worldwide and we will continue our efforts towards commercialization of chemoluminescence-based RECAF tests.

In addition, and of equal importance, it should be noted that, BioCurex will always be a high technology, science-driven company. We will continue working on RECAF based therapeutic applications, the point-of-care RECAF tests to be used at the doctor’s office, etc.

BioCurex will keep its shareholders informed on the developments related to the commercialization of its products in future disclosures, along with the size and potential of various global markets for its RECAF technology.

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 here.

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.

biocurex

The Company has not authorized the release of this information in any form that contravenes the Communication Act and will not be responsible for unsolicited massive distribution of this material by e-mail or facsimile by unauthorized parties. Statements in this press release, which are not historical facts, are ‘forward-looking statements” within the meaning given to that term in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Company’s actual results could differ materially from expected results.

BioCurex, Inc.

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