Inova Diagnostics announces the CE mark for Aptiva

Aptiva will bring efficiency and reliability to the autoimmune laboratory by providing clinicians with more information on managing autoimmune disease patients.

Inova Diagnostics announced the CE mark for Aptiva. Aptiva is an entirely automated digital multi-analyte system that represents the next generation of high-throughput processors for the clinical laboratory.

Aptiva utilizes a particle-based multi-analyte technology (PMAT), solves many health economic deficits in the autoimmune laboratory. Existing systems deliver a limited number of analytes that do not reduce the seronegative gap that occurs in many disease states. In addition to its current portfolio of celiac assays, Aptiva will target seven additional autoimmune disease states in the future and has more than 60 analytes in various stages of advanced development. These additional analytes under development will help clinicians fill the seronegative gap and improve diagnostic confidence. Additionally, Aptiva can deliver up to 720 results per hour with a 12 analyte test cassette, allowing the laboratory to complete its workflow in a single shift.

Dr Marcos López Hoyos, Head of Immunology, Universitario Marqués Valdecilla Hospital at the University of Cantabria in Santander, Spain said: “I am excited about the approval for Aptiva. It is the fruit of a long-awaited technological breakthrough and a major one step forward to deliver a range of next-generation results that will enhance autoimmune diagnostics and provide clinicians with reliable test results.”

Roger Ingles, CEO, Inova Diagnostics stated: “Inova Diagnostics is pleased to introduce Aptiva in the EU. Inova Diagnostics has a 33-year history of providing laboratories with innovative autoimmune diagnostic products. Aptiva continues this tradition.”

Dr Michael Mahler, Vice President Research and Development, Inova said: “Aptiva’s broad disease- and syndrome-based analyte portfolio is a breakthrough that fundamentally improves the usefulness of diagnostic tests in the laboratory. Aptiva will bring efficiency and reliability to the autoimmune laboratory and provide clinicians with more information on how to manage autoimmune disease patients.”

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