The new test aids in the qualitative detection and differentiation of RNA of influenza A and B viruses and respiratory syncytial virus (RSV). Extraction and amplification is performed in one protocol with no separate nucleic acid extraction step.

The test is intended to aid in the diagnosis of Clostridium difficile-associated disease, one of the most common and dangerous acquired infections in healthcare settings. It uses a proprietary technique to eliminate the time consuming nucleic-acid sample extraction process required by many other molecular tests, for potentially faster results reporting for hospitals and clinical laboratories.

The Simplexa™ Dengue molecular test kit developed Focus Diagnostics has been registered for distribution in Brazil. The test kit is the first commercial real-time polymerase chain reaction (RT-PCR) test to be approved for use by Brazil’s public and private health laboratories for testing for Dengue viruses.

The Simplexa™ Flu A/B & RSV Direct test uses a proprietary technique to eliminate nucleic-acid sample extraction, a time-consuming process required by other molecular test products, for faster results reporting.

The Simplexa™ C. difficile Universal Direct test on the 3M™ Integrated Cycler enables fast, high volume lab testing – eliminating the traditional extraction step and allowing for processing of up to 94 patient specimens in about an hour.

The Simplexa™ molecular chemistries for the 3M™ Integrated Cycler were honored with a Bronze-level award for best new science and medical diagnostic product during the 2011 Edison Awards gala ceremony in New York City. Winners were selected based upon criteria that included technological innovation, market and social impact, and marketplace success.

The U.S. Food and Drug Administration (FDA) issued 510(k) clearance to the Simplexa™ Flu A/B & RSV test on the 3M™ Integrated Cycler. The test aids in the detection and discrimination of influenza A, influenza B and RSV virus infections.

The U.S. Food and Drug Administration (FDA) issued a second emergency use authorization (EUA) for the Simplexa™ Influenza A H1N1 (2009) test. With this EUA, Focus Diagnostics is the only company in the U.S. to offer test kits for detecting the 2009 H1N1 virus during the pandemic.

The U.S. Food and Drug Administration (FDA) has granted Quest Diagnostics’ Focus Diagnostics business unit an emergency use authorization for its test for detecting the 2009 H1N1 influenza virus.