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FDA Clearance of Lactate Test


  • Published: 2010-06-15 : Author: Epocal, Inc.
  • Synopsis: FDA clearance to market new lactate test on the epoc Blood Analysis System.

Epocal Announces FDA Clearance of Lactate Test - Test further expands clinical utility of epoc System for point-of-care blood analysis.

Epocal, Inc., a leading edge provider of point of care technology, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market its new lactate test on the epoc Blood Analysis System. Lactate measurements from the epoc System are used to evaluate acid-base status and for diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). The addition of lactate to the epoc BGEM Test Card, which includes in vitro diagnostic tests for pH, pO2, pCO2, Na, K, iCa, Hct and Glu (plus calculated values), further expands the clinical utility of the Company's point of care blood gas and electrolyte platform. Lactate on the BGEM Test Card represents the second metabolite cleared for use on the epoc System in the past 12 months. It is also the ninth measured analyte on the single-use test card, surpassing most competitive point of care systems which may require multiple test devices in order to match the same menu.

"Epocal reaffirms its commitment to patient care by adding this critical test to its cost effective, comprehensive point of care platform," said Imants Lauks, Epocal Inventor and CEO. "The epoc technology continues to excite healthcare with its ability to improve delivery of patient care, reduce operating expenses and increase efficiency throughout the entire healthcare enterprise."

About Epocal, Inc. -Epocal, Inc., headquartered in Ottawa, ON, Canada with U.S. Sales and Marketing operations in Horsham, PA, develops, manufactures and markets the epoc Blood Analysis System. epoc (enterprise point of care) is healthcare's first cost effective point of care testing solution to leverage SmartCard technology and the power of wireless communication to provide critical caregivers with real-time, laboratory quality test results at the patient's bedside. The epoc System is marketed co-exclusively by Epocal, Inc. and Alere in all geographies worldwide, except for Japan, India, Nepal, Bhutan and Sri Lanka. Additional information about the epoc System and Epocal, Inc. is available on the Company's website - www.epocal.com

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