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E-Z-EM, Inc. announced the formal launch of the company's new EZ CHEMTM blood analyzer, a convenient point-of-care device for conducting blood assays in patients prior to certain imaging procedures.

Nova Biomedical - the company's development partner for EZ CHEM - submitted a 510(k) application for the base technology, under the product name StatSensor, to the US Food and Drug Administration (FDA) in January 2007. Nova received FDA clearance for StatSensor in May 2007. Nova has since completed all remaining regulatory and engineering requirements for EZ CHEM, including the preparation and filing of all necessary documentation, and the product is now cleared for sale in the US. The company expects to begin shipping initial units to select clinical sites in the coming weeks.

EZ CHEM performs a simple test for assessing kidney function right in the imaging suite, and produces results in as little as 30 seconds. The device analyzes a finger prick sample of blood for levels of creatinine-an important indicator of a patient's renal function. Such blood values are often required to determine a patient's kidney function before IV contrast agents are administered.

Evaluating a patient's kidney function can help determine their ability to safely receive IV contrast prior to CT and MR imaging procedures-an important precaution especially for patients with risk factors such as diabetes, known kidney impairment, and advanced age. Currently, such blood tests must be sent to a lab before the patient can undergo a CT or MRI procedure, a time-consuming step that can cause delays in busy radiology departments.

Commenting on the announcement, Brad S. Schreck, the Company's Senior Vice President-Global Sales, Marketing and Engineering, said, "EZ CHEM provides the ability to quickly and accurately assess kidney function where it is needed most, at the point-of-care. Screening for patients with renal insufficiency has been in focus recently, as certain contrast agents, particularly those used in MRI, have been associated with Nephrogenic Systemic Fibrosis (NSF) - a debilitating and potentially severe condition that currently has no clear and widely successful treatment. We believe EZ CHEM will help reduce the risks associated with the use of IV contrasts for certain patients while improving productivity in the imaging suites, all through a simple, reimbursable test. We have been pleased to work with Nova Biomedical during the development phase and are excited to begin offering EZ CHEM to the radiology and gastroenterology marketplace.