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Harrington Group Files 510(k) For Saliva Drug Screening Device Oraline
Melbourne, Oct 24, 2007 (ABN Newswire) - Harrington Group (ASX: HGR) advises that having completed the necessary studies the Company's subsidiary Sun Biomedical Laboratories (SBL) has filed for US Food and Drug Administration (FDA) 510(k) clearance for the Company's saliva illicit drug screening device OraLine.
The Company will resume selling Oraline into the US workplace testing market once 510(k) clearance has been received from the FDA. The product is presently marketing for forensic use.
The Company is the first organisation to file for a multi drug 510(k) clearance on a saliva illicit drug testing device and is optimistic subject to FDA review that clearance could be achieved within the first quarter of calendar year 2008. With no saliva tests having attained 510(k) clearance, the Company views the matter of compliance with FDA guidelines as a strategic imperative that will provide a significant competitive advantage in the U.S. market.
All available resources are focused on delivering 510(k) clearance in the shortest practical timeframe.
About HARRINGTON GROUP LIMITED
Harrington Group Ltd is a public company listed on the Australian Stock Exchange (ASX) under the symbol "HGR". As a publicly listed entity HGR has undergone a number of evolutions moving from an organisation with a diverse portfolio of investments to the present organisation which is clearly focused on the invitro diagnostics market.
Through the acquisition of Sun Biomedical Laboratories Inc (SBL), HGR has acquired a portfolio of unique invitro diagnostic intellectual property with a specific focus and expertise in the use of saliva as the diagnostic medium. The immediate opportunity to be realised through SBL is the global commercialisation of their benchmark oral-fluid illicit drug screening device OraLine which has established an industry benchmark with the most sensitive detection levels particularly for marijuana which is the most commonly consumed illicit substance both in Australia, the United States and throughout Europe.
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