ELITech Receives FDA Clearance for MRSA/SA Test

ELITech Molecular Diagnostics has announced it has received FDA clearance for its methicillin-resistant Staphylococcus aureus/Staphylococcus aureus ELITe MGB test, according to a news release.

 

The company describes the MRSA/SA test as a multiplex, qualitative real-time PCR assay for the direct detection of SA and MRSA DNA purified from human nasal swab specimens.

 

"We are very pleased to introduce this newest molecular diagnostic test that addresses a critical unmet need for clinicians and healthcare providers," said Pierre Debiais, president and CEO of the ELITech Group, in the release. "MRSA/SA ELITe MGB utilizes a unique biomarker design for improved accuracy that results in fewer MRSA false negative and false positive results. The unique design of ELITech's MRSA/SA ELITe MGB, with our exclusive MGB Technology, provides an important new tool that will help clinicians effectively detect MRSA/SA and aid in the prevention and control of MRSA infections. MRSA/SA ELITe MGB is the first 510(k) cleared molecular diagnostics test from ELITech, and will soon be followed by C. difficile ELITe MGB currently pending FDA clearance."

 

ELITech Group is headquartered in Puteaux, France, while ELITech North America is headquartered in Princeton, N.J.

 

Related Articles on FDA Clearances:

Covidien Receives FDA Clearance for Bedside Patient Monitoring System

Siemens Receives FDA Clearance for MRI System

Roche Receives FDA Clearance for Insulin Pump Therapy System

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