LifePoint Receives US FDA Clearance for the Impact Test System for Medical Use
LifePoint, Inc. (AMEX:LFP), a provider of non-invasive drug diagnostic technologies and solutions, has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the LifePoint(R) IMPACT(R) Test System in conjunction with the opiate test (morphine and heroin) for use in medical markets.
The initial submission for the test “system”, consisted of a submission for the instrument, validated software and one chemistry test – the test for opiates. This clearance allows for use of the IMPACT Test System in FDA regulated medical markets such as hospital emergency rooms, laboratories, physician office laboratories, occupational health clinics, home health care, etc.
“This approval begins to open up a massive new market for LifePoint,” stated Linda H. Masterson, President and CEO of LifePoint, Inc. “There is a tremendous need in the medical community for a non-invasive and fast drug test to improve accurate diagnosis and care. In emergency situations especially, medical professionals are required to make rapid, on-the-spot decisions. Unlike current blood tests, our test system provides immediate and accurate results within minutes of administration so that medical professionals can provide the best possible care in critical situations.”
Ms. Masterson continued, “Our primary focus in the near-term will be to continue to launch our product in the law enforcement and industrial workplace. In parallel, we will begin selling our product to customers, including those overseas, that require US FDA clearance. The opportunity with hospitals will only increase as we receive approval for additional drug tests from the FDA. Now that we have obtained clearance of the automated instrument, software, and an initial chemistry test for opiates, we will re-initiate our submissions on the remaining chemistry tests and expect an expeditious review process. We are also very pleased with the product claims allowed which show that our on-site product demonstrated a 98.5% agreement with conventional laboratory tests, the current “gold standard” of the industry. Our tests are accurate and also less costly and time consuming to administer compared to laboratory tests.”
About LifePoint, Inc
LifePoint, Inc., a provider of non-invasive drug diagnostic technologies and solutions, has developed, manufactures and markets the IMPACT Test System – a rapid diagnostic testing, screening and drug monitoring device for use in the workplace, ambulances, pharmacies, law enforcement and home healthcare markets. LifePoint’s patented and proprietary technologies for the use of saliva as a non-invasive, blood-comparable test specimen, used in conjunction with the flow immunosensor technology licensed from the United States Navy, has allowed LifePoint to develop a broadly applicable, rapid, on-site diagnostic test system. The first product simultaneously detects drugs of abuse and alcohol, and the initial three target markets – law enforcement, industrial workplace and medical emergency room – are estimated to be over $1.6 billion worldwide. www.LifePointInc.com
LifePoint(R) and IMPACT(R) are trademarks of LifePoint, Inc.
