Navigation Links
AMDL Submits Data to FDA for Clearance to Market Its DR-70(R) Diagnostic Test to Monitor Colorectal Cancer Patients
Date:10/15/2007

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


'/>"/>
SOURCE AMDL, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Neurognostics receives special FDA clearance for MindState fDAD
2. Third Wave receives FDA clearance of pharmacogenetic test
3. GE Medical Systems Receives FDA Clearance for New MRI System
4. Reforming FDA: Focus on safety, let market judge efficacy
5. Internet-enabled niche markets take center stage
6. GE Healthcare leads compact ultrasound market
7. Tech upstart VoVision could disrupt the voice-recognition market
8. Corn prices and ethanol: Are the markets flaky - or working as they should?
9. TomoTherapy sees sustained market advantage
10. Can a talent market work inside organizations?
11. Risks and returns: Building a search engine marketing portfolio
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... Atlanta, it seems everyone has a chance to express their ... expressive and dynamic community unlike any other. The businesses that ... With their newest salon in ... on that tradition with a unique, fresh approach to head ... the newest of 13 nationwide locations, each of them well-situated ...
(Date:2/23/2017)... , Feb. 23, 2017  Imanis Life Sciences ... line of oncolytic vaccinia viruses for virotherapy research. ... part of Genelux,s proprietary, vaccinia virus-based technology platform ... to enter into a partnership with Genelux to ... vaccinia viruses for use in research," said Dr. ...
(Date:2/23/2017)... ... February 23, 2017 , ... ... that in a published evaluation of multiple immunoassay-based threat detection technologies by ... Energy Laboratory, PathSensors’ CANARY® biosensor threat detection technology was found to have ...
(Date:2/23/2017)... ... February 23, 2017 , ... Today, ... cortisol, CRP, adiponectin, uric acid, and/or other biomarkers or SNPs of interest) using ... Salimetrics’ SalivaLab , the relationship between insulin and other relevant biomarkers can ...
Breaking Biology Technology:
(Date:2/8/2017)... About Voice Recognition Biometrics Voice recognition biometrics ... a stored voiceprint template. Acoustic features of an ... are compared to distinguish between individual voices. Voice ... PCs already have a microphone and can authenticate ... are most likely to be deployed in telephone-based ...
(Date:2/8/2017)... , Feb. 7, 2017 The biometrics ... by the confluence of organizations, desires to better ... knowledge-based systems (password and challenge questions), biometrics is ... government systems. The market is driven by use ... between consumer and enterprise uses cases, with consumer-facing ...
(Date:2/7/2017)... Zimmer Biomet Holdings, Inc. (NYSE and SIX: ... at the LEERINK Partners 6th Annual Global Healthcare Conference ... February 15, 2017 at 10 a.m. Eastern Time. ... be accessed at http://wsw.com/webcast/leerink28/zbh .  The webcast will ... Biomet,s Investor Relations website at http://investor.zimmerbiomet.com . ...
Breaking Biology News(10 mins):