Nanosphere tests for success

NORTHBROOK, IL--Nanosphere’s Verigene system is a photonic workstation for nucleic acid (DNA or RNA) and protein diagnostics.

Oct 15th, 2008

NORTHBROOK, IL--Nanosphere’s Verigene system is a photonic workstation for nucleic acid (DNA or RNA) and protein diagnostics. It is designed to allow the simultaneous detection of multiple genetic or protein targets with a single test. Both the Verigene System and its first test--which assesses an individual’s ability to metabolize the blood thinning medication Warfarin received FDA clearance in September 2007. Sold under the brand name Coumadin, Warfarin is the most-prescribed oral anticoagulant in North America and Europe, and the second most common cause of emergency room visits for adverse drug events. Since then, Nanosphere has had another test approved, and the company went public (NSDQ: NSPH) in November 2007.

Nanosphere’s recipe for success involves a number of factors, including turnaround speed, test sensitivity, and equipment cost: Nanosphere’s relatively inexpensive and easy-to use technology could enable hospitals to conduct their own tissue sample tests on site, instead of sending them off to labs for processing by highly trained personnel on expensive machines--and waiting for return.

Comprising two core instruments--the Verigene Reader and the Verigene Processor--and a single-use test cartridge, the system is based on patented gold nanoparticle technology, which is part of a clever optics setup that is an important part of the system’s performance. The nanoparticles attach to target sequences, and the gold is coated with highly reflective silver using a proprietary chemistry. The coated particles attach to a glass substrate that acts as a waveguide when illuminated by LEDs. Nanosphere’s use of nanotechnology is another important contributor to system performance: Verigene is “at least 100 times more sensitive” than other techniques, says Bill Cork, VP of R&D and the company’s CTO. And reportedly the technology is also 100,000 times more selective, with far fewer false positives and false negatives.

Nanosphere also applies this technology to detection of proteins, often biomarkers of disease. “With greater sensitivity we should be able to detect disease much earlier, enabling more effective treatment and better patient outcomes,” explains Bill Moffitt, Nanosphere’s CEO. “For example, early clinical data for our cardiac troponin I assay, currently in development, indicates that it can detect cardiovascular disease within the first two hours a patient is in the emergency room,” says Moffitt.

“About 13.2 million people a year go to emergency rooms complaining of chest pain and shortness of breath, classic symptoms of acute coronary syndrome,” says Moffitt. “Only about 2% of those are actually suffering a STEMI coronary, a kind of acute myocardial infarction that can be detected on an EKG. The remaining 98% are either experiencing other forms of acute coronary syndromes such as milder forms of myocardial infarct or they are having non-heart related problems such as anxiety or gastroesophageal reflux. In order to preserve heart muscle and improve patient outcomes, early detection is very important.”

“Lacking analytical sensitivity, today’s commercially available assays often take 8–12 hours or more to detect NSTEMI coronaries (a somewhat less severe form of a myocardial infarct), delaying treatment decisions. Moreover, today’s assays are not sufficiently sensitive to diagnose unstable angina and many of these patients will be discharged only to experience a myocardial infarct within a few months--and many of these folks will die,” Moffitt says. “Therefore, it is no surprise that myocardial infarct is the number one driver for malpractice lawsuits against emergency physicians.”

Nanosphere aims to quickly determine those patients suffering from acute coronary syndromes and provide accurate diagnosis of those patients suffering unstable angina. At the same time, Nanosphere believes its test will provide a very early rule-out for cardiovascular disease, thereby reducing the cost of patient care and helping to relieve congestion in emergency rooms. Moffitt says the Nanosphere technology will detect “much, much earlier” those patients truly in danger and provide the earliest warning signal for those suffering the early stages of cardiovascular disease. The company is targeting commercial launch of the product in mid 2009.

Other tests, improved ease of use

Meantime, the company has an assay for cystic fibrosis in clinical trials, and expects to submit it to the FDA later this year. A flu test is due out in early 2009 and the company has scheduled for development another protein test for earlier detection of recurrent prostate cancer based upon the biomarker prostate specific antigen (PSA), which increases in concentration as the prostrate becomes diseased. “There are lots of these in the market,” says Moffitt, “but once the prostrate is removed surgically, virtually all patients’ PSA drops to levels that are undetectable by standard technology--and yet 40% of such patients get recurrent cancer.” Early tests on Nanosphere’s technology indicate an ability to catch these cases within the first 90 days, he reports.

The company is also exploring tests for cancer, autoimmune disease, and Alzheimers. Moffitt says, “For protein tests, the value proposition is greater sensitivity and earlier detection of disease,” he adds, saying that the tests are “at least 100 times more sensitive” than current technology allows.

In the midst of all this, the company is working to improve its instrument platform. “The first-generation Verigene System requires some sample prep,” says Moffitt. Verigene II will not, and thus will further simplify testing.

--Barbara Goode

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