LifePoint Impact Test System Receives US FDA Clearance for Industrial Workplace, Insurance and School Use.
ONTARIO, Calif. -- LifePoint, Inc. (AMEX: LFP), a provider of non-invasive drug diagnostic technologies and solutions, announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the LifePoint(R) IMPACT(R) Test System in conjunction with the opiate (heroin and morphine) test for use in "repetitive use situations", which defined by the FDA guidelines published in April 2004 includes drug testing in the workplace, insurance and schools.
"The IMPACT Test System's second FDA clearance for use in 'repetitive use situations' significantly expands the market for our product in the general consumer sector," said Linda H. Masterson, President and CEO of LifePoint, Inc. "The need for drug testing is more prevalent in our daily lives than we realize, especially in the workplace and in schools. Our test's fast and on-the-spot results allows administrators to take immediate action to protect both the abuser and their surrounding peers."
Ms. Masterson continued, "While FDA clearance is not currently required for use of the test system in 'repetitive-use situations', we proactively filed an application to give us a competitive advantage by staying ahead of the agency's anticipated regulation of this market. As with the medical clearance, the most time-consuming portion of the review process was educating the FDA on our novel product design. This is the first diagnostic product that the FDA has ever reviewed and cleared that has a completely automated and integrated sample collection, sample processing, sample distribution, chemistry analysis and data generation process. With this clearance, we expect an expedited review process for future chemistry test submissions."
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.
This press release contains forward-looking statements regarding future events and the future performance of LifePoint, Inc. that involve risks and uncertainties that could cause actual results to differ materially. These risks include, but are not limited to, potential need for additional financing, FDA 510(k) clearance in medical markets, dependence on third parties for certain marketing efforts, and market acceptance. These risks are described in further detail in the Company's reports filed with the Securities and Exchange Commission.
LifePoint(R) and IMPACT(R) are trademarks of LifePoint, Inc.
