FDA Grants AMDL Clearance to Market the AMDL-ELISA DR-70(R) (FDP) Blood Test for Monitoring Colorectal Cancer
July 07 2008 - 10:10AM
PR Newswire (US)
TUSTIN, Calif., July 7 /PRNewswire-FirstCall/ -- AMDL (AMEX:ADL), a
leading vertically integrated bio-pharmaceutical company with
operations in China and the US, announced today the US Food and
Drug Administration (FDA) has issued a letter of substantial
equivalence to an existing predicate device and granted clearance
to market the AMDL-ELISA DR-70(R) (FDP) as a safe and effective
blood test for monitoring patients who have been previously
diagnosed with colorectal cancer (CRC). According to US-based
medical research group Kalorama Research, the world market for in
vitro diagnostic (IVD) tests for cancer is growing at nearly 11%
annually and could reach nearly $8 billion by the end of 2012
(Kalorama Research Group: 2008). The FDA clearance to market was
based upon data showing DR-70 (FDP) has the ability to monitor the
progression of colorectal cancer post-surgery in patients who are
biopsy confirmed with this disease. "This clearance to market
provides CRC patients with access to a potentially lifesaving
test," said Gary Dreher, AMDL's chief executive officer.
"Post-surgery testing with DR-70 is a valuable aid in monitoring
disease progression in patients previously diagnosed with CRC.
Today's announcement introduces a promising new choice for the
hundreds of thousands of patients diagnosed with this potentially
deadly, but highly treatable disease." CRC is the third most common
cancer worldwide and the second leading cause of cancer deaths
(irrespective of gender) in the United States according to the
National Cancer Institute (Cancer Facts and Figures 2008). It is
estimated there will be approximately 150,000 new cases diagnosed
in the US in 2008, roughly 51,000 deaths due to the disease, and
almost half of all patients thought to be "cured" will develop a
recurrence of CRC within 5 years -- usually due to undetected
metastases. (Shike M, Winawer SJ, Greenwald PH, et al.: Bull World
Health Organ) Today's announcement marks the first clearance to
market that the FDA has granted for any monitoring product for CRC
since January 14, 1982 when Carcinoembryonic Antigen (CEA) was
approved. Until now, the CEA test has been the only accepted method
cleared in the U.S. DR-70 (FDP) offers a new test that can monitor
CRC tumors post-surgery. The DR-70 (FDP) test is cleared in Canada
for the detection of lung cancer and was recently cleared to import
in Korea and Taiwan as a general cancer screen. It also has the CE
mark from the European Union for sale in Europe as a general cancer
screen. About AMDL-ELISA DR-70 (FDP): DR-70 (FDP) is an
Enzyme-Linked ImmunoSorbent Assay (ELISA) -- a sensitive,
well-established diagnostic laboratory test that can be added
easily and inexpensively to the pre-existing line of diagnostics
performed routinely by clinical laboratories through out the U.S.
Additional information on the AMDL-ELISA DR-70 (FDP) test can be
obtained on AMDL's corporate website at http://www.amdl.com/ or by
contacting the Company at 714.505.4460. About AMDL: AMDL is
headquartered in Tustin, CA. with operations in Shenzhen, Jiangxi,
and Jilin, China. AMDL, Inc., along with its subsidiary Jade
Pharmaceutical Inc. (JPI), is a vertically integrated
bio-pharmaceutical company devoted to the research, development,
manufacturing, and marketing of diagnostic, pharmaceutical,
nutritional supplement, and cosmetic products. The Company employs
approximately 320 people in the US and China. The Company has an
additional four pharmaceutical and diagnostic products under review
by various regulatory authorities. Forward-Looking Statements
Statements in this press release may constitute forward-looking
statements and are subject to numerous risks and uncertainties,
including the market's acceptance or demand for DR-70 or any of the
Company's products, failure to complete successfully the
development of other new or enhanced products, the Company's future
capital needs, any actions by the Company's distribution channels
that may be adverse to the Company, the success of competitive
products, other economic factors affecting the Company and its
markets, and other risks detailed from time to time in the
Company's filings with the Securities and Exchange Commission. The
actual results may differ materially from those contained in this
press release. The Company disclaims any obligation to update any
statements in this press release. AMDL Contact: Kristine Szarkowitz
206.310.5323 206.201.3286 DATASOURCE: AMDL CONTACT: Kristine
Szarkowitz of AMDL, +1-206-310-5323, +1-206-201-3286, Web site:
http://www.amdl.com/
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