Vela Diagnostics Announces the Listing of Their Next-Generation Sequencing System With the U.S. FDA as a Class II Medical Device
(firmenpresse) - SINGAPORE -- (Marketwired) -- 11/25/14 -- Vela Diagnostics announced today that it has completed the listing of its Next-Generation Sequencing (NGS) system with the U.S. Food and Drug Administration (FDA) for clinical use as a class II device.
The Vela Diagnostics NGS System comprises the Sentosa® ST401 instruments which provide an automated solution for template preparation and enrichments, the Sentosa® SQ301 sequencer and server, as well as the Sentosa® SQ Reporter for efficient data analysis and report generation.
The Vela Diagnostics NGS System and the Sentosa® SX101 automated pipetting system form the Sentosa® Next-Generation Sequencing (NGS) workflow -- the first automated NGS workflow currently available in the market.
"Due to a lack of automation and sample traceability, as well as the generation of large amounts of data, which require advanced molecular biology and informatics skills, NGS technology has so far been perceived to be of limited use in the routine laboratory. Vela Diagnostics provides the answer to these challenges by offering an automated workflow," says Michael Tillmann, Vela Diagnostics'' CEO.
Vela Diagnostics'' Sentosa® NGS workflow is intended for targeted sequencing and enables simultaneous screening of hundreds of genes and quick turn-around time, thereby providing the appropriate technologies for today''s increasingly complex laboratory needs together with improved efficiency and flexibility. Availability and regulatory status of products are country-dependent.
Vela Diagnostics is a worldwide provider of integrated molecular diagnostics workflows that address individual testing needs. Established in 2011 with its global headquarters in Singapore, Vela Diagnostics provides innovative test and data reporting solutions for Real-Time PCR and Next-Generation Sequencing. Integrating both PCR and NGS solutions to test for infectious diseases and oncologic targets increases flexibility and efficiency of the workflow and enables laboratories to overcome complex diagnostic challenges. Reliable and multi-purpose instruments help reduce the cost for optimal efficiency across laboratories of all sizes. With scalability and open-channel capabilities, laboratories also benefit from the flexibility and versatility of the systems. For more information, please visit .
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.
Cynthia Lanzendoen
Director of Marketing
973-521-7324
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Datum: 25.11.2014 - 13:00 Uhr
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