BioCurex Inc. Submits Pre-Investigational Device Exemption (IDE) to the FDA for RECAF(TM)
In a previous announcement, BioCurex compared the performance of RECAF and free-PSA to discriminate prostate cancer from benign prostate hyperplasia (BPH), a common benign condition that requires no surgical treatment. The RECAF test outperformed the established free-PSA test by approximately 600% in its ability to prevent unnecessary prostate biopsies. (BioCurex's RECAFTM Blood Test for Cancer Can Prevent Two Thirds of Unnecessary Prostate Biopsies Sep 8th, 2011).
The INTENDED USE in the submission reads: "The serum-RECAFTM CLIA test is an in-vitro device for the quantitative measurement of RECAF (receptor for Alpha-fetoprotein) in human serum. The RECAF test is intended to be used in men aged 50 years or older with total PSA values between 4-10 ng/ml and non-suspicious DRE. The RECAF value can be used as an aid in discriminating between prostate cancer and benign disease. Prostatic biopsy is required for the diagnosis of cancer".
Dr. Ricardo Moro, CEO of BioCurex, stated, "This pre-IDE submission is the first step toward seeking FDA approval of our RECAFTM test. This process is aimed at avoiding errors and detours on behalf of the applicants and therefore, should help to speed the regulatory process."
According to the FDA, the pre-IDE process can be thought of as a "pre-submission" process. It may involve sending analytical or clinical protocols to FDA for review and comment before proceeding with studies. The process may also involve a meeting with FDA to discuss protocols and/or possible regulatory pathways. Pre-IDE submissions and meetings are strictly voluntary, and any comments or recommendations made in the review of protocols or during these meetings are not binding on the Agency or the Sponsor. A submission made under the pre-IDE process is not an official IDE application as described in 21 CFR Part 812. In fact, most in vitro diagnostic devices (IVDs) are exempt from the medical device IDE regulations as long as conditions in 21 CFR 812.2(c)(3) are met.
http://www.canaryfoundation.org/publications/pre-IDE%20integrated%20v03%20030421.pdf
http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistance/ucm123682.htm#4b and
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.htm#pre_ide)
The pre-IDE process is designed to help companies obtain early, informal input on aspects of a future IDE application and offers assistance in establishing the parameters for official IDE applications when unique diagnostic tests involving innovative technologies are being pursued.
About BioCurex, Inc.
BioCurex, Inc. is a biotechnology company that is developing products based on patented and proprietary technology in the area of cancer diagnostics. The technology identifies a universal cancer marker known as RECAF.
RECAF is a molecule that is present on cancer cells but not detected in significant levels on healthy cells or benign tumor cells. It is the receptor for alpha-fetoprotein and is classified as an oncofetal antigen due to its presence on both fetal and malignant tissues. This characteristic makes RECAF a more accurate indicator of cancer than most current tumor markers.
BioCurex plans to commercialize its technology through licensing arrangements with companies that develop and market diagnostic tests for the large automated clinical laboratory setting, through development and marketing of non-automated clinical laboratory tests, through development of rapid, point-of-care test formats, and through marketing of its OncoPet RECAF test for cancer in companion animals.
BioCurex has signed licensing agreements for its cancer detection blood tests with Abbott Laboratories (NYSE:ABT - News) and with Alere (NYSE:ALR - News), formerly Inverness Medical Innovations.
For further information on these agreements visit:
http://sec.gov/Archives/edgar/data/1092562/000100487808000117/sb2amnd4s1april08.txt.
For more information about the Company, please visit www.BioCurex.com.
For more information about OncoPet Diagnostics Inc., please visit: www.OncoPetDiagnostics.com.
Forward-Looking Statements
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.
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