Singapore (May 20, 2014) – Vela Diagnostics announced today the CE-IVD launch of Sentosa® SA Direct MRSA/SA PCR Test for the Real-Time PCR qualitative detection of Staphylococcus aureus (SA) and Methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs in patients at risk for nasal colonization, to aid in the prevention and control of MRSA/SA infections in healthcare settings.

The Sentosa® SA Direct MRSA/SA PCR Test allows laboratories to detect and differentiate MRSA from SA. In addition, a broad range of SCCmec cassette types (Type I to VIII XI) as well as both the mecA and novel mecC genes are identified. The comprehensive detection of MRSA related target sequences provide valuable information for clinical decision making. 

The Sentosa® SA Direct MRSA/SA PCR Test is validated for use with the Sentosa® SX Lysis Beads and Sentosa® SA Reporter. This workflow allows for direct sample lysis and automated result interpretation thus driving laboratory efficiency by shortening the Turn-Around Time from sample to results.

“With the addition of the newly launched CE-IVD marked Sentosa® SA Direct MRSA/SA PCR Test, we offer clinicians an array of molecular tests to aid the overall management of hospital-acquired infection. We are well on track this year to provide clinicians with a complete portfolio of qPCR tests on a single platform,” said Vela Diagnostics CEO Mr. Michael Tillmann.

S. aureus is a major cause of nosocomial infections with clinical manifestations ranging from pustules to sepsis and death¹. The pathogen is usually transmitted through the contaminated hands of people carrying S. aureus. Treatment of S. aureus infections has become a real challenge with the emergence of strains resistant to previously effective antimicrobial agents.

MRSA is a bacterium responsible for several difficult-to-treat infections in humans. MRSA is a strain of S. aureus that has developed resistance to beta-lactam antibiotics, including penicillins (e.g. methicillin) and cephalosporins. MRSA infections are associated with high morbidity, mortality, and costs. In the US alone, there are at least 80,000 severe MRSA infections per year leading to 11,000 deaths².

The Sentosa® SA Direct MRSA/SA PCR Test is not available in the US.

References:

¹ Centers for Disease Control and Prevention (2001). Methicillin-resistant Staphylococcus aureus skin or soft tissue infection in the state prison-Mississippi, 2000. MMWR Morb Mortal Wkly Rep. 50, 919–922.

² U.S. Department of Health and Human Services. Centers for Disease Control and Prevention http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf#page=77

Vela is a trademark of Vela Holding Pte Ltd. Sentosa is a registered trademark of Vela Holding Pte Ltd in several markets including the US and the European Union.