FDA Clears Inova Diagnostics’ Digital Multi-Analyte System

Inova Diagnostics, a worldwide leader in IVD systems and reagents for autoimmune disease in the clinical laboratory, has received U.S. Food and Drug Administration 510(k) clearance for its Aptiva System and Aptiva Celiac Disease IgA assay. Aptiva is a fully automated digital multi-analyte system that represents the next generation of high-throughput processors for the clinical laboratory. Aptiva received CE (Conformité Européenne) marking in August 2020.

“I am truly excited about the approval of Aptiva,” commented Dr. Marcos López Hoyos, head of Immunology Department, Hospital Universitario, Marqués Valdecilla, Cantabria University, Santander, Spain. “It is the fruition of a long-anticipated technology breakthrough and marks a significant step forward to deliver a set of next generation results that will improve the utility of autoimmune diagnostics and provide clinicians reliable test results.”
 
Aptiva addresses many health economic shortcomings in the autoimmune laboratory. Existing systems provide a limited number of analytes that do not reduce the seronegative gap found in many disease states. Beyond the current Celiac assay, Aptiva will include seven additional autoimmune disease states and has over 60 analytes in various stages of advanced development. These additional analytes will help clinicians close the seronegative gap and improve diagnostic confidence.  

“Aptiva’s broad disease and syndromic-based analyte portfolio is a breakthrough that fundamentally enhances the utility of diagnostic testing in the laboratory,” said Michael Mahler, Ph.D., vice president of Research and Development at Inova. “Aptiva will bring efficiency and reliability to the autoimmune laboratory and provide expanded information to clinicians for management of patients with autoimmune diseases.”
 
Aptiva also delivers several economic benefits for the laboratory. The 150-sample rack capacity reduces the number of daily interventions and a 6.5-hour consumable walkaway time delivers new levels of workflow efficiencies. Aptiva uses a particle-based multi-analyte technology (PMAT) that processes multiple analytes simultaneously from a patient sample. PMAT enables Aptiva to deliver up to 720 results per hour using a 12-analyte test cartridge and allows the laboratory to complete its workflow in a single shift.  
 
“Inova Diagnostics is pleased to launch Aptiva in the U.S.,” said Roger Ingles, chief operating officer of Inova Diagnostics. “Inova Diagnostics has a 34-year history of providing laboratories with products required for autoimmune diagnosis. Aptiva continues this tradition.”
 
Inova Diagnostics is a privately held company headquartered in San Diego, Calif., and is a part of Werfen, a global leader in IVD with a long-term commitment to providing innovative solutions for hospitals and clinical laboratories to improve patient care. Inova Diagnostics manufactures IVD systems, reagents for autoimmune disease and is a leader in the development and commercialization of new autoimmune technologies and diagnostic markers.