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[MartyMan]

BOCX The FDA Classification of BioCurex's Histo-RECAF Kit

Tue Apr 20 01:02:00 2004 EST
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