AMDL Submits Data to FDA for Clearance to Market Its DR-70(R) Diagnostic Test to Monitor Colorectal Cancer Patients
October 15 2007 - 5:00AM
PR Newswire (US)
TUSTIN, Calif., Oct. 15 /PRNewswire-FirstCall/ -- AMDL, Inc.
(AMEX:ADL), developer and marketer of tests for the early detection
of cancer and other serious diseases, announced today that it has
filed with the U.S. Food & Drug Administration (FDA) for
clearance to market its unique, proprietary DR-70(R) (FDP) ELISA
tumor marker test for use as an aid in monitoring patients
previously diagnosed with colorectal cancer. AMDL used the guidance
provided at the meeting they had with the FDA on January 25, 2007.
In its submission to the FDA, AMDL and its statistical consultant,
Dr. Richard P. Chiacchierini of RPCA in Rockville, MD, have
provided statistical evidence that the DR-70(R) (FDP) ELISA is an
"informative test" to validate AMDL's claim that the DR-70(R) (FDP)
ELISA is effective at monitoring colorectal cancer patients. AMDL's
DR-70(R) (FDP) ELISA is an in vitro diagnostic test for the
DR-70(R) (FDP) antigen in human serum. When cleared to market by
the FDA, it will be used as an aid in monitoring the disease status
in patients who have been previously diagnosed with colorectal
cancer. AMDL believes that the test will be useful as an aid in
monitoring cancer patients throughout the course of the disease,
including after primary surgery, and in determining the response to
therapy. "FDA clearance to market will be a major step for AMDL in
the acceptance of DR-70(R) (FDP) for the monitoring of colorectal
cancer, not only in the U.S. but worldwide. We have forwarded to
the FDA the data that we believe will show the efficacy and safety
of our test," said Gary L. Dreher, President and CEO. About AMDL
More information about AMDL and its products can be obtained at
http://www.amdl.com/. Forward-Looking Statements Statements in this
press release may constitute forward-looking statements and are
subject to numerous risks and uncertainties, including the failure
to complete successfully the development of new or enhanced
products, the Company's future capital needs, the lack of market
demand for any new or enhanced products the Company may develop,
any actions by the Company's partners 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. Contact: AMDL, Inc. Paul Knopick AMDL Investor Relations
Direct Line: 949.707.5365 VoiceMail: 714.505.4460 DATASOURCE: AMDL,
Inc. CONTACT: Paul Knopick, AMDL Investor Relations,
+1-949-707-5365, voicemail, +1-714-505-4460, for AMDL, Inc. Web
site: http://www.amdl.com/
Copyright
Amdl (AMEX:ADL)
Historical Stock Chart
From May 2024 to Jun 2024
Amdl (AMEX:ADL)
Historical Stock Chart
From Jun 2023 to Jun 2024