11:45AM Medtox Scientific receives FDA 510(k) clearance for its new Sure-Screen Device (TOX) 6.40 +0.05:Co announces it has received 510(k) clearance from the FDA to market its Sure-Screen drugs-of-abuse point-of-collection test device. Sure-Screen is a Point of collection device intended to provide significantly lower detection levels for eight commonly abused drugs.
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MEDTOX Scientific Receives FDA 510(k) Clearance for Its New Sure-Screen(R) Device Wednesday November 2, 11:45 am ET
ST. PAUL, Minn.--(BUSINESS WIRE)--Nov. 2, 2005--MEDTOX Scientific, Inc. (AMEX:TOX - News), announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Sure-ScreenŽ drugs-of-abuse point-of-collection test (POCT) device.
Sure-ScreenŽ is a POCT device intended to provide significantly lower detection levels for eight commonly abused drugs. Current tests provide detection levels that have been established by the Substance Abuse and Mental Health Services Administration (SAMHSA), a Federal agency that regulates certain workplace drug testing required under Federal law. Those detection levels have been broadly adopted by both laboratories and device makers for all drug screening. The SAMHSA established detection levels are generally intended to deter drug abuse and minimize litigation related to employment drug screening, but not necessarily to detect all usage.
The Company believes there is a demand for the much lower detection levels in certain markets that are interested in "zero tolerance." Specific markets to which Sure-ScreenŽ will be targeted are, probation, parole, drug rehabilitation, hospital emergency departments, physician office clinics, laboratories, and corporate clients interested in lower detection levels for pre-employment testing. In all of these markets there is value added in reducing the detection level for abused drugs, and therefore increasing the number of those detected abusing drugs.
Clinical data supports that Sure-ScreenŽ will provide lower detection levels on eight drugs (marijuana, opiates, cocaine, amphetamines, methadone, benzodiazepines, methamphetamines, and MDMA-Ecstasy) by an average of approximately 50% each.
Sure-ScreenŽ creates a significant competitive advantage, as the Company is currently unaware of any existing FDA cleared POCT devices with this broad panel and low detection levels. MEDTOX Scientifics unique structure in owning an ISO certified medical device manufacturer and a federally certified drug testing laboratory creates additional competitive advantages in two ways. First, Sure-ScreenŽ is a preliminary on-site screen that may require further laboratory confirmation. MEDTOX Laboratories can provide that confirmation in a seamless manner. Second, there are a limited number of laboratories that are either willing or capable of confirming the low drug levels that will be detected by Sure-ScreenŽ.
MEDTOX Scientific, Inc., headquartered in St. Paul, Minn., is a provider of high quality specialized laboratory testing services and on-site/point-of-collection (POC) devices. The company also supports customers with complete logistics, data and program management services. MEDTOX is a leader in providing esoteric laboratory testing services to hospitals and laboratories nationwide. This includes both central laboratory and bio-analytical testing for pharmaceutical clinical trials. MEDTOX develops and manufactures diagnostic devices for quick and economical on-site/point-of-collection analysis for drugs-of-abuse, therapeutic drugs and biological and agricultural toxins and provides employment drug screening and occupational health testing. For more information see www.medtox.com. Posted by Peaser01 on :