Nanosphere develops, manufactures and markets an advanced molecular diagnostic platform, the Verigene System, which enables simple, cost-effective, and highly sensitive nucleic acid (DNA and RNA) and protein testing on a single platform.
Our breakthrough technology helps hospitals improve patient care and lowers costs by providing time-critical information, allowing earlier detection of disease and more targeted treatment. Our products have the potential to:
- Empower physicians to better manage infectious diseases through timely and clinically actionable diagnostic information;
- Enable earlier detection of life-threatening disease through ultra sensitive protein tests, while advancing the viability and clinical significance of new and existing biomarkers;
- Improve patient outcomes and reduce medical costs through point-of-care pharmacogenetic tests.
The Verigene System is differentiated by its ease of use, rapid turnaround times and ability to detect many targets on a single test, referred to as multiplexing. We are developing, completing clinical trials, and commercializing a broad menu of tests.
Direct Detection of Nucleic Acids
Nanosphere’s direct nucleic acid detection technologies are greatly simplifying molecular diagnostic testing, making it accessible to virtually any clinical setting. This allows for localized molecular diagnostic testing and decision-making at small clinics and the greater than 4,000 hospital-based laboratories in the United States. A similar number of hospital laboratories in the EU and other regions of the globe will benefit similarly by having access to a testing platform that does not require substantial technical and operational expertise.
Nanosphere has developed tests in the following clinical areas:
High-sensitivity Protein Diagnostics
Nanosphere's nanoparticle probe technology enables high-sensitivity, multiplexed detection of proteins in clinical samples. Detection of new and existing protein biomarkers at sensitivity levels 2-3 orders of magnitude higher than existing ELISA-based tests is being explored in several areas, including:
- Neurodegenerative Disorders.
Nanosphere's technology for high-sensitivity protein detection can facilitate the discovery of new biomarkers for both clinical applications and drug development.
Nanosphere was founded in 1999 based upon nanotechnology discoveries at Northwestern University in Evanston, Illinois by Dr. Robert Letsinger and Dr. Chad Mirkin. Among other achievements, these discoveries made possible the manufacturing and functionalization of gold nanoparticles with oligonucleotides (DNA or RNA), or antibodies that can be used in diagnostic applications to detect nucleic acid or protein targets, respectively.
Since then, Nanosphere has created state-of-the-art manufacturing facilities compliant with Good Manufacturing Practices (GMP) at its Northbrook headquarters, where all Verigene instruments and test kits are made. A world-class sales, marketing, and customer support organization have joined forces with an experienced clinical affairs team to successfully guide Nanosphere's innovative products through regulatory agencies around the world, including the FDA, and into the global market.
As of December 31, 2012, Nanosphere’s patent portfolio is comprised, on a worldwide basis, of 186 issued patents and 14 pending patent applications which, in either case, we own directly or are the exclusive licensee. Some of these patents and patent applications derive from a common parent patent application or are foreign counterpart patent applications and relate to similar or identical technological claims. The issued patents cover approximately 11 different technological claims and the pending patent applications cover approximately three additional technological claims. Many of Nanosphere's issued and pending patents were exclusively licensed from the International Institute for Nanotechnology at Northwestern in May 2000, and they generally cover Nanosphere's core technology, including nanotechnology-based biodiagnostics and biobarcode technology. In addition, as of December 31, 2012, we have non-exclusive licenses for at least 42 U.S. patents that cover 11 different technological claims from various third parties.