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First Molecular Tem-PCR Test to Identify Multiple Forms of Staph and MRSA Obtains CLIA Certificate

Tuesday, August 5, 2008 General News J E 4
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HUNTSVILLE, Ala., Aug. 4 Diatherix Laboratories, anindependent clinical reference laboratory located in the Hudson-AlphaInstitute for Biotechnology, announced today it has received its ClinicalLaboratory Improvement Amendment (CLIA) certificate* for its proprietarylicensed 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 multiplepathogens, both viral and bacterial in a single test. In less than four hoursTem-PCR can simultaneously differentiate pathogens with Staphylococcus anddetermine their associated drug resistance. Tem-PCR can identify four types ofStaphylococcus strains, including the increasingly important bacterium knownas Methicillin-resistant Staphylococcus aureus (MRSA).

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

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

"This revolutionary molecular testing technology allows the healthcareprovider a cost effective diagnostic tool which can identify multipleinfectious diseases faster and with far more accuracy than any other testavailable," said Dennis Grimaud, chief executive officer of DiatherixLaboratories. "Our Tem-PCR test can differentiate between the sometimes-fatalMRSA, Staph aureus, and other forms of Staph. This is important becausenon-MRSA patients can be treated with more effective and often less expensivedrug therapies, and without the need for patient isolation. In less than fourhours Tem-PCR can identify four types of Staph and three types of antibioticresistance. Our test delivers accurate diagnostic information that willprovide physicians the exact information they need to administer specific andeffective infectious disease treatment. Tem-PCR technology is also an enormousbenefit to hospitals from a business and financial perspective. In additionto identifying the most efficient treatment protocols, hospitals will now beable to determine whether a patient has an infection at the time of admission,thereby determining whether treatment is reimbursable. This will be vitalinformation for hospitals if Medicare decides to deny reimbursement forhospital 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 foradvanced research. Dr. Han overcame the limitations of traditional Real TimePCR (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 differentiationbetween the pathogens and/or their various strains in a single test.

"Infections are a challenge for all hospitals, both clinically and interms of financial reimbursement," said Grimaud. "However, it is important tounderstand that MRSA represents less than 5 percent of total hospitalinfections. Massive attention is being paid to all infections, whetherhospital or community acquired, because of the impending Medicare regulations.In addition to MRSA, healthcare facilities across the country are inundatedwit
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