Werfen, a Spain-based company that develops, manufactures and distributes specialised diagnostic instruments, related reagents, automation workcells, and data management solutions for use mainly in hospitals and independent clinical laboratories, announced on Monday that it has received the CE (Conformite Europeenne) mark for its Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents under the European Union's (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR).
The Aptiva APS IgG and APS IgM reagents are immunoassays that use Aptiva particle-based multi-analyte technology (PMAT) for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (a beta 2GP1) IgG and IgM autoantibodies in human serum and citrated plasma. The products are utilised to support in the diagnosis of primary and secondary APS, when used in conjunction with with other laboratory findings.
Michael Mahler, PhD, vice president of Research and Development at Werfen, said, 'Antiphospholipid syndrome is an autoimmune disease that manifests clinically as venous or arterial thrombosis and/or fetal loss and can be challenging to diagnose as its symptoms can mimic those of other conditions. Early diagnosis is crucial in preventing complications as well as unnecessary procedures and increased healthcare costs. Aptiva APS IgG and APS IgM deliver expanded information to clinicians to help with the diagnosis and management of patients with autoimmune diseases.'
Adicet Bio secures FDA Fast Track Designation for ADI-001 to treat refractory SLE
Acrivon Therapeutics receives FDA Breakthrough Device designation for ACR-368 OncoSignature assay
Vistagen secures US patent for AV-101 in neuropathic pain treatment
Thermo Fisher Scientific launches international registry for adolescent alopecia areata
hVIVO successfully completes RSV antiviral trial for Shionogi
Valneva secures UK approval for world's first chikungunya vaccine
Alys Pharmaceuticals' IND for ALY-101 approved in US and Canada
NeuroTherapia's Phase 2 Alzheimer's disease trial receives European regulatory approval
NFL Biosciences confirms superior safety profile of NFL-101 in new toxicity study
Avirmax Biopharma completes first cohort of Wet AMD clinical trial
PhaseV collaborates with Alimentiv to address challenges in GI clinical trials
HOPE Therapeutics and NRx Pharmaceuticals select BTIG as financial advisor
Helix unveils clinico-genomic dataset of over 15,000 patients treated with GLP-1 agonists
Roquefort Therapeutics sells Lyramid for USD10.8m equity deal with Pleiades Pharma