Novartis Develops Rapid Diagnostic Tool

System may improve diagnosis of immunogolbulin E-related conditions.

A new diagnostic system developed by Novartis, Niji System and Total IgE Test, may allow for quick, in-office diagnosis of severe allergic asthma, which can lead to better patient outcomes.

The device is based on a proprietary pyro-electric technology that supports the design of a rapid immunoassay blood test, according to Novartis. The point-of-care diagnostic tool can identify total Immunoglobulin E (IgE) levels in approximately 12 minutes, and only requires a few droplets of blood.

This allows for an in-office diagnosis of IgE-mediated allergic disorders, such as asthma. Identifying uncontrolled asthma due to IgE is currently an unmet need that could potentially be met with the new diagnostic system.

Current diagnostic IgE tests are conducted in laboratories, and can take several weeks to provide results. This can lead to treatment delay, loss to follow-up, and hospitalization due to uncontrolled asthma exacerbations, in some cases.

The Niji System has demonstrated comparable performance to the current tests, Novartis reported. A more rapid diagnosis and implementation of a treatment plan can lead to improved outcomes and quality-of-life.

Some other benefits to the device include no sample preparation, lengthy setup, or calibration, according to Novartis. They plan to launch the Niji System late this year in the European Union, and in countries that recognize the CE Mark.

“Point-of-care testing is an important tool for healthcare 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," said Vas Narasimhan, MD, Global head of Drug Development and chief medical officer for Novartis. "The Niji System provides a platform for fast and easy blood tests that could potentially be applied across a variety of disease areas."