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First Molecular Tem-PCR Test to Identify Multiple Forms of Staph and MRSA Obtains CLIA Certificate
Date:8/4/2008

Identifies deadly hospital pathogens

A single, fast and accurate test identifies four Staph strains

simultaneously

HUNTSVILLE, Ala., Aug. 4 /PRNewswire/ -- Diatherix Laboratories, an independent clinical reference laboratory located in the Hudson-Alpha Institute for Biotechnology, announced today it has received its Clinical Laboratory Improvement Amendment (CLIA) certificate* for its proprietary licensed testing process, Target Enriched Multiplex Polymerase Chain Reaction (Tem-PCR). This molecular differential diagnostic technology is the first Tem- PCR test introduced to the clinical market which is able to identify multiple pathogens, both viral and bacterial in a single test. In less than four hours Tem-PCR can simultaneously differentiate pathogens with Staphylococcus and determine their associated drug resistance. Tem-PCR can identify four types of Staphylococcus strains, including the increasingly important bacterium known as Methicillin-resistant Staphylococcus aureus (MRSA).

The Centers for Disease Control and Prevention (CDC) has reported that MRSA infections have doubled in the past six years. The ability to accurately identify these pathogens is important because, beginning in October 2008, hospitals across the country may no longer receive Medicare reimbursement for many hospital acquired infections.

Prior to the Tem-PCR molecular technology, it was not possible to quickly and effectively differentiate between hospital-acquired infections (HAI) and community-acquired infections (CAI) in a single molecular test. Unlike hospital acquired MRSA which affects patients in a hospital, community-acquired MRSA often occurs in healthy people who are not receiving medical care and hospitalization. The ability to differentiate between CA-MRSA and HA-MRSA may assist hospitals in preventing non-reimbursement for MRSA infections.

"This revolutionary molecular testing technology allows the healthcare provider a cost effective diagnostic tool which can identify multiple infectious diseases faster and with far more accuracy than any other test available," said Dennis Grimaud, chief executive officer of Diatherix Laboratories. "Our Tem-PCR test can differentiate between the sometimes-fatal MRSA, Staph aureus, and other forms of Staph. This is important because non-MRSA patients can be treated with more effective and often less expensive drug therapies, and without the need for patient isolation. In less than four hours Tem-PCR can identify four types of Staph and three types of antibiotic resistance. Our test delivers accurate diagnostic information that will provide physicians the exact information they need to administer specific and effective infectious disease treatment. Tem-PCR technology is also an enormous benefit to hospitals from a business and financial perspective. In addition to identifying the most efficient treatment protocols, hospitals will now be able to determine whether a patient has an infection at the time of admission, thereby determining whether treatment is reimbursable. This will be vital information for hospitals if Medicare decides to deny reimbursement for hospital acquired infections after October 1."

Jian Han, M.D., PhD, Laboratory Director of Diatherix Laboratories, invented Tem-PCR technology, which until now has only been available for advanced research. Dr. Han overcame the limitations of traditional Real Time PCR (RT-PCR) technology, a test that can only identify one pathogen at a time. Another limitation of RT-PCR is that it does not identify the differentiation between the pathogens and/or their various strains in a single test.

"Infections are a challenge for all hospitals, both clinically and in terms of financial reimbursement," said Grimaud. "However, it is important to understand that MRSA represents less than 5 percent of total hospital infections. Massive attention is being paid to all infections, whether hospital or community acquired, because of the impending Medicare regulations. In addition to MRSA, healthcare facilities across the country are inundated with other infections, all of which can be more cost-effectively and rapidly identified through this new and exciting technology. Early, precise and cost-effective treatment can now be achieved with genetic accuracy. We can now provide Tem-PCR to medical facilities all across the country, and patients can start to benefit from this advance in genetic science. Later this year we will release our Hospital Acquired Infection Panel which identifies 16 of the most common hospital acquired infections and our Respiratory Panel which will test for 21 respiratory pathogens, both viral and bacterial, all in a single molecular test."

Diatherix Laboratories Inc. is located in the Hudson-Alpha Institute for Biotechnology in Huntsville, Alabama. Diatherix operates as an independent clinical laboratory providing advanced multiplex molecular diagnostic services such as Tem-PCR to identify infectious disease to hospitals and the healthcare community. Diagnostic Network Alliance (DNA), with representative offices throughout the United States, is the exclusive US distributor for Diatherix Laboratory. DNA and Diatherix Laboratories share corporate administrative headquarters in Brentwood, Tenn.

*Clinical Laboratory Improvement Amendments (CLIA) was passed by Congress in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The final CLIA regulations were published in the Federal Register on February 28, 1992. The requirements are based on the complexity of the test and not the type of laboratory where the testing is performed. On January 24, 2003, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) published final CLIA Quality Systems laboratory regulations that became effective April 24, 2003.


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SOURCE Diatherix Laboratories Inc.
Copyright©2008 PR Newswire.
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