POC Diagnostic Tool Introduced for Allergic Disorder Biomarker

Identifying patients with uncontrolled asthma mediated by immunoglobulin E remains an area of high unmet need and it is estimated that in Europe, more than 30 million people are affected by asthma, and approximately half of patients remain uncontrolled.

Current immunoglobulin E tests are performed in central laboratories and it can take up to several weeks before results are known; however point of care testing (P-O-C) in the healthcare provider's office has the potential to reduce the time from consultation to diagnosis and to treatment decision, leading to improved patient outcomes.

Immunoglobulin E (IgE) and the total concentration in blood (Total IgE) is an important biomarker for the diagnosis and management of atopic asthma and other allergic conditions. Elevated IgE can be used as a first indicator for atopic asthma in the general population. In patients with asthma, higher IgE levels are associated with increased asthma severity and reduced lung function.

A novel in-office point of care diagnostic tool, the Niji System and Total IgE Test (Novartis, Basel, Switzerland) has recently been introduced and the test delivers quantitative total IgE levels in about 12 minutes using approximately 30µL of finger stick blood. The test has a dynamic range of 30 to 1,500 IU/mL, allowing for quick in-office diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings.

The Niji System does not require any sample preparation, lengthy setup, or any calibration procedures. Clinical and non-clinical performance evaluations conducted with the Niji Total IgE Test demonstrated performance comparable to currently marketed reference laboratory tests. The test may be a useful tool for healthcare professionals as an aid in the diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings in their office setting.

The Niji System is for use by medical professionals and consists of a small desktop analyzer, optional accessories, and test-specific disposable cartridges. It is based on a proprietary pyro-electric technology that supports the design of sensitive, rapid immunoassay tests using unprocessed capillary blood specimens. This allows the development of tests, which quantitate proteins, antibodies, drug molecules and metabolites in capillary blood and other body fluids within 10 to 15 minutes. The system is now cleared for sale within the European Union and in all countries recognizing the CE Mark and the company intends to launch the system in Europe in Q4 2016.

Vas Narasimhan, MD, Global Head of Drug Development and Chief Medical Officer for Novartis, said, “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. The Niji System provides a platform for fast and easy blood tests that could potentially be applied across a variety of disease areas.”

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