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4/20/2004 1:02:00 AM
RICHMOND, British Columbia, Apr 19, 2004 (BUSINESS WIRE) -- BioCurex Inc. (Pink Sheets:BOCX) is pleased to provide a clarification of the FDA classification of its Histo-RECAF(TM) product.

In May 2001, BioCurex submitted an application to the FDA regarding its Histo-RECAF(TM) kit. The submission included data, pictures from stained tissue sections and reports from pathologists who had evaluated the test. It also included the user manual, which was revised and corrected according to the instructions and helpful suggestions from the FDA officer.

The Food and Drug Administration (FDA) subsequently classified BioCurex's Histo-RECAF(TM) as a Class I device under Regulation Number 864.1850(i). Item (b) reads:

-- (b) Classification. Class I (general controls). These devices
are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the
limitations in Sec. 864.9. These devices are also exempt from
the current good manufacturing practice regulations in part
820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec.
820.198, with respect to complaint files.


The FDA has not "approved" the Histo-RECAF product for the diagnosis of cancer. Instead, the FDA has classified Histo-RECAF(TM) as a Class I device (lower cost and time frame) which allows BioCurex to sell the product for use as specified in its manual as follows:

-- Intended Use

-- Histo-RECAF(TM) is a qualitative ligand-binding histochemical
test kit for use as an adjunct to standard light microscopy
staining methods for detection of alphafetoprotein binding on
formalin-fixed, paraffin-embedded tissue sections as an aid in
the identification of breast cancer in breast and axillary
node tissues. Diaminobenzidine is the chromogen used in the
test kit.


Furthermore, the Company directs the pathologist in the Limitations section of that manual as follows:

-- 5) The clinical interpretation of any positive staining or its
absence must be evaluated within the context of clinical
presentation, morphology and other histopathological criteria.
The clinical interpretation of any staining, or its absence
must be complemented by morphological studies and proper
controls as well as other diagnostic tests. Staining is to be
performed in a certified licensed laboratory under the
supervision of a pathologist who is responsible for reviewing
the stained slides and assuring the adequacy of positive and
negative controls.


The pathologist who examines a tissue biopsy under the microscope typically looks for specific abnormalities associated with cancer. These can include invasion of adjacent areas and shape and size of cells. To visualize these features, the cells must be colored with a stain; for example Hematoxylyn & Eosin or the Papanicolau stain used for PAP smears. Histo-RECAF can also assist the pathologist by staining malignant cells. The FDA has placed Histo-RECAF(TM) within the classification name: "STAIN, PAPANICOLAU(ii)", the stain used in PAP smears used for detection of cancer. The Papanicolau stain is not "approved" as a device for "cancer diagnosis" either, but its role as a stain in the diagnosis of cervical cancer is undeniable.

Histo-RECAF(TM), as a Class I device, is intended to assist the pathologist who will still rely on multiple tools and morphological criteria for reaching a final diagnosis.

For more information about the FDA approving process, visit: http://www.fda.gov/cdrh/devadvice/3122.html

About BioCurex:

BioCurex, Inc. is a biotechnology company that is developing products based on patented/proprietary technology in the areas of cancer diagnosis. The technology identifies a cancer marker known as RECAF(TM), which is found on malignant cells from a variety of cancer types but is absent in most normal or benign cells. To read more about the Company, please visit the News section in our web site ( www.biocurex.com).

Note: 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.

(i) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?FR=864.1850

(ii) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/ search.cfm?db=LST&ID=79217

(Due to the length of the above URLs, it may be necessary to copy and paste these hyperlinks into your Internet browser's URL address field. You may also need to remove an extra space in the URL if one exists.)

SOURCE: BioCurex, Inc.

BioCurex, Inc.
Ricardo Moro, 604-207-9150