Focus Diagnostics and 3M Launch FDA-Cleared Simplexa™ Test on 3M™ Integrated Cycler for Molecular Influenza and Respiratory Virus Testing by Moderate Complexity Healthcare Facilities
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.
Focus Diagnostics Wins Bronze Medical Design Excellence Award (MDEA) in the in vitro Diagnostics Category
Simplexa™ Direct Chemistry technology won a bronze award in the in vitro diagnostics category at the 2012 MDEA awards ceremony held May 23. Focus Diagnostics manufactures the Simplexa™ Direct line of molecular test products for use on the 3M™ Integrated Cycler as part of an exclusive global collaboration with 3M.
FDA Clears the Quest Diagnostics Simplexa® C. difficile Molecular Test
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.
Quest Diagnostics Launches Simplexa™ Dengue Test in Brazil, First Commercial Molecular Test Approved for Nation’s Public and Private Health Testing
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.
Quest Diagnostics CE Marks Simplexa™ Test for Cytomegalovirus for Sale in Europe
The Simplexa™ CMV kit on the 3M™ Integrated Cycler is designed to enable hospital laboratories to perform advanced molecular testing for cytomegalovirus. With this new test, Focus Diagnostics now offers one of the most comprehensive molecular transplant-testing menus in Europe.
Quest Diagnostics Announces Launch of Simplexa™ Direct Test for Influenza and Respiratory Viruses in Europe
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.
Quest Diagnostics Wins Gold Medical Design Excellence Award (MDEA) for Diagnostic Innovation
The Simplexa™ molecular chemistries for the 3M™ Integrated Cycler won a Gold-level award in the in vitro diagnostics category at the 2011 MDEA awards ceremony in New York City. Winners were selected by an impartial jury on criteria that included design and engineering features that improve healthcare delivery and innovative use of materials or components.
Quest Diagnostics Launches Simplexa™ C. Difficile Universal Direct Test in Europe
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.
Quest Diagnostics CE Marks Simplexa™ Tests for Epstein Barr and BK Viruses for Sale in Europe
The two Simplexa-branded molecular test kits are CE marked for distribution to approximately 35 countries in Europe. They are the first products from the Simplexa™ line to aid in the clinical management of patients with compromised immunity.
Quest Diagnostics Honored for Diagnostic Innovation at 2011 Edison Awards
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.
FDA Clears Influenza and Respiratory Virus Test Kit from Quest Diagnostics’ Focus Diagnostics Business
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.
First FDA Clearance of a 2009 H1N1 Test Given to Quest Diagnostics’ Focus Diagnostics Business
The U.S. Food and Drug Administration (FDA) issued 510(k) clearance to the Simplexa™ Influenza A H1N1 (2009) test on the 3M™ Integrated Cycler. The test aids in the detection and discrimination of influenza A and 2009 H1N1 viral RNA.
FDA Issues Another Emergency Use Authorization for Commercial H1N1 Flu Test to Quest Diagnostics’ Focus Diagnostics
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.
Focus Diagnostics Launches 2009 H1N1 Flu Test Kit to Commercial Laboratories in the U.S.
The Simplexa™ Influenza A H1N1 (2009) test is available as a kit for use by “high complexity” clinical laboratories in the U.S. The test aids physicians in diagnosing patients infected with the pandemic virus rather than other influenza A strains.
FDA Grants First Authorization of a Commercial 2009 H1N1 Flu Test for use During Pandemic Flu Emergency to Quest Diagnostics’ Focus Diagnostics Business
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.