Multi-antibody blood test for AAV now available in European Union
Technology shortens time it take to get results, its maker says
Alivedx’s Mosaiq Aiplex vasculitis assay, a platform test for the two main self-reactive antibodies that drive most cases of ANCA-associated vasculitis (AAV), is now available for clinical use in the European Union (EU).
The test is also able to detect self-reactive antibodies linked to another autoimmune condition marked by inflammation of small blood vessels called anti-glomerular basement membrane (GBM) disease.
Mosaiq Aiplex vasculitis assay received an in vitro diagnostic regulation (IVDR)-CE mark. This mark certifies the safety of diagnostic tests performed on biological samples such as blood. Countries throughout the EU, as well as other countries accepting the IVDR-CE mark, may now use the test.
“Achieving IVDR-CE Mark approval is a major step forward in our mission to bring best-in-class healthcare solutions to clinicians, labs – and most of all, patients across Europe,” Manuel O. Méndez, CEO of Alivedx, said in a company press release. “Our MosaiQ technology provides [multiple] test results fully automated and at speed, which shortens time to results and supports accelerated diagnosis of autoimmune diseases, improving patient outcomes and reducing healthcare costs.”
Platform can streamline laboratory testing
AAV is a group of autoimmune diseases marked by inflammation and damage to small blood vessels. Depending on where in the body this damage occurs, symptoms may vary between individuals.
In most cases, a type of self-reactive antibody, called anti-neutrophil cytoplasmic antibody (ANCA), drives the abnormal immune attacks that ultimately lead to damage. ANCAs typically target one of two enzymes: proteinase 3 (PR3) or myeloperoxidase, (MPO). Different types of ANCAs are often associated with different AAV types and clinical trajectories.
Measuring levels of these antibodies in the blood may be part of the AAV diagnostic process and can also help clinicians track disease activity. Currently, clinicians may need to use separate blood samples or multiple machines to test for these two types of ANCAs.
Alivedx’s Mosaiq platform for multiplexed tests, or those detecting multiple compounds simultaneously, can streamline laboratory testing, potentially reducing test turnaround to less than one day. The system can automatically process several tests using only one instrument.
This milestone confirms our commitment to meeting the highest standards of safety, performance, and quality with yet another panel in our portfolio.
The Mosaiq Aiplex vasculitis test, which requires only 10 microliters of blood, can detect both anti-MPO ANCAs and anti-PR3 ANCAs, as well as anti-GBM antibodies, which drive anti-GBM disease.
Also known as Goodpasture’s disease, anti-GBM disease is marked by small blood vessel inflammation in the kidneys and lungs. In rare cases, people with AAV may also develop anti-GBM disease, potentially worsening their prognosis.
The vasculitis test isn’t yet available in the U.S., but the IVDR-CE mark it received signifies the device meets EU safety, health, and environmental protection requirements.
“This milestone confirms our commitment to meeting the highest standards of safety, performance, and quality with yet another panel in our portfolio,” Méndez said.
Other Mosaiq tests that have received IVDR-CE marks include multiplexed tests for allergies, celiac disease, and connective tissue disease, including several autoimmune diseases.
About the Author
