Epocal, Inc.

Epocal, Inc.

October 29, 2012 08:00 ET

Epocal's Creatinine and Chloride Tests Receive FDA Clearance

epoc® Blood Analysis System can now aid in the detection of kidney disease and additional electrolyte and metabolic disorders

OTTAWA, ONTARIO, CANADA--(Marketwire - Oct. 29, 2012) - Epocal, Inc., a leading provider of point-of-care diagnostic technology, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's creatinine and chloride tests, which are performed on the epoc® Blood Analysis System, for the U.S. market. Creatinine, which can be used to help diagnose and treat certain kidney diseases as well as monitor kidney dialysis, and chloride, which can help diagnose and treat several electrolyte and metabolic disorders, will be added to the epoc® BGEM Test Card. The test card currently includes in vitro diagnostics for pH, partial pressure of oxygen, partial pressure of carbon dioxide, sodium, potassium, ionized calcium, hematocrit, glucose, and lactate.

Renal injury impacts a large percentage of hospitalized patients, especially those receiving treatment in intensive care units. With the epoc® Blood Analysis System, creatinine can be measured at the patient's bedside to screen for and detect early kidney damage as well as monitor kidney status. In conjunction with other parameters, it can also help to inform treatment decisions related to renal function, such as the use of renal replacement therapy or the identification of potentially nephrotoxic agents. Additionally, many critically-ill patients suffer from acid-base imbalances, especially those receiving intravenous treatment. Chloride measurements can help clinicians assess these imbalances and make adjustments where necessary.1

"With the addition of creatinine and chloride to the epoc® BGEM Test Card, we now provide the most comprehensive menu available to the handheld blood analysis market on a single test card. By facilitating rapid, informed treatment decisions, the expanded test card will help clinicians better manage critically-ill patients and generate process improvements that keep caregivers at the patient's side," said Dr. Imants Lauks, Epocal CEO.

The epoc® Blood Analysis System delivers a full menu of results, including creatinine and chloride, in less than a minute on a PDA. Results can be easily integrated into any Laboratory Information System (LIS), and the system's broad menu will benefit clinical service lines that routinely perform blood analysis, including the emergency department, radiology, cardiac catheterization labs, out-patient centers, and critical care units.

About Epocal, Inc.

Epocal, Inc., headquartered in Ottawa, ON, Canada manufactures 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. Additional information about the epoc® System and Epocal, Inc. is available on the Company's website at www.epocal.com. The epoc® System is marketed for human use exclusively by Alere in all geographies worldwide. For sales and customer service please contact Alere at: (888) 893-6225 or visit www.alere.com.

(1) Mohd Yunos et al. Critical Care 2010, 14:226

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