Press Releases Detail:
Avitar, Inc. Submits For Fda 510(K) Clearance Of Oralscreen
December 21, 2000
CANTON, MA, December 21, 2000 – Avitar, Inc. (AMEX: AVR) today announced that it has submitted a Premarket Notification 510(k) for evaluation and review by the Food and Drug Administration to determine substantial equivalence of its ORALscreen™ 3 Test System, intended for qualitative detection of cannabinoids, cocaine, and opiates drugs-of-abuse in oral fluid, to a previously marketed test system.
"FDA Clearance to Market of our ORALscreen™ 3 Test System would provide us with the ability to sell our product in the regulated clinical diagnostics market, which represents approximately ten percent of the $1.5 billion substance abuse testing marketplace," said Doug Scott, Avitar’s President.
"Building on our recently secured patent protection for the ORALscreen™ Collector, FDA 510(k) Clearance to Market would leverage our unique innovative intellectual property and trade secrets in oral fluid diagnostics," said Peter Phildius, Avitar’s Chairman and Chief Executive Officer.
Avitar, Inc. leads the market as the first and only U.S. manufacturer to supply rapid screening oral fluid-based on-site substance abuse tests, since its introduction of ORALscreen™ in April 1999. The company’s sensitive oral fluid technology non-invasively samples saliva to detect trace amounts of illegal primary substances and metabolites in the body. The ORALscreen™ 3 Test System identifies the positive presence of marijuana, cocaine and opiates.
ABOUT AVITAR, INC.
Avitar, Inc. (AMEX: AVR) headquartered in Canton, Massachusetts, develops, manufactures and markets innovative medical devices based on core technologies in oral fluid diagnostics and customized polyurethane applications. The company markets a unique portfolio of substance abuse testing products and services that include ORALscreenTM, the world’s first rapid point-of-collection oral fluid test for drugs of abuse, ORALadvantage™, the first comprehensive substance abuse program featuring its oral fluid-based products, HAIRscreenTM, a laboratory-based test for detecting long term drug abuse using hair, and several other specialized tests for drugs of abuse. ORALscreen is a cost-effective drugs-of-abuse test with potential net cost savings of more than $100.00 per sample tested. Additional products include an oral fluid collection system for DNA testing as well as a proprietary line of polyurethane-based high tech medical devices.
For more information, see Avitar’s website at avitarinc.com.
This release forward looking statements that are subject to risks and uncertainties, including the development and marketing of new applications and other risks that are detailed from time to time in the Company’s filings with the Securities and Exchange Commission.