New Point-of-Care Test Can Diagnose Severe Allergic Asthma

Novartis has introduced a new point-of-care diagnostic tool that allows for in-office diagnosis of uncontrolled allergic asthma mediated by immunoglobulin E (IgE) in conjunction with other clinical findings.

The company’s Niji System and Total IgE Test deliver quantitative total IgE levels from 1 or 2 droplets of finger-stick blood in roughly 12 minutes. The system consists of a small desktop analyzer and test-specific disposable cartridges, and it is based on pyroelectric technology that supports the design of sensitive, rapid immunoassay tests that use unprocessed capillary blood specimens. It is now cleared for sale in all countries recognizing the CE Mark, and Novartis intends to launch it in Europe later in 2016.

Novartis is currently developing tests for the Niji System to address unmet needs for patient diagnosis, which includes identifying those with IgE-mediated severe allergic asthma.

Elevated IgE levels can be used as an initial indicator of atopic asthma, as IgE is a critical biomarker for the diagnosis and management of atopic asthma and other allergic conditions. In patients already diagnosed with asthma, higher IgE levels are associated with reduced lung function and increased disease severity.

“Point-of-care testing is an important tool for health care professionals in order to make informed treatment decisions within a single appointment, thus helping to ensure patients are not lost to follow-up and ultimately improving patient management and outcomes,” stated Vas Narasimhan, MD, Global Head of Drug Development and Chief Medical Officer for Novartis, in a press release.

Currently, IgE tests are performed in central laboratories, and it can take up to several weeks before results are known.