The FINANCIAL — Novartis announcedon September 9 the introduction of a novel in office point of care diagnostic tool – the NijiTM System and Total IgE Test. This first test delivers quantitative total IgE (Immunoglobulin E) levels in about 12 minutes using only one to two droplets of finger stick blood, allowing for quick in-office diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings.
Identifying patients with uncontrolled asthma mediated by IgE remains an area of high unmet need. It is estimated that in Europe, more than 30 million people are affected by asthma, and approximately half of patients remain uncontrolled. Point of care testing 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. Current IgE tests are performed in central laboratories and it can take up to several weeks before results are known, according to Novartis.
“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.”
Novartis recently completed all requirements for the CE Mark of the point of care diagnostic platform NijiTM System as well as the Total IgE Test. 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.
The NijiTM System does not require any sample preparation, lengthy setup, or any calibration procedures. Clinical and non-clinical performance evaluations conducted with the NijiTM 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.
Discussion about this post