This story was originally posted on April 29.
Nanosphere this week said that it plans to submit a number of tests to the US Food and Drug Administration for approval, and provided more details about its intentions to expand in Europe.
During the firm's first-quarter earnings call, Nanosphere executives said that the company has completed data collection in a fast track trial toward submitting its cardiac troponin I assay for FDA approval later this year, and said that discussions with the FDA on submitting the company’s 2C19 test for Plavix metabolism have accelerated.
"We think we're on schedule to commence running the [troponin assay] samples this summer," CEO Bill Moffitt said in the call. "Once we get started, we're probably three to four months away from filing with the FDA, which obviously we expect to be this year," he said.
Nanosphere execs also said the company has identified partners to guide it through the premarket and regulatory process for the new assay, "paving the way for launch later in 2011."
The cardiac troponin I assay measures the levels of proteins believed to play a role in cardiovascular diseases. It runs on The Northbrook, Ill.-based firm's Verigene system, a benchtop workstation that uses gold nanoparticle technology to detect nucleic acid and protein targets of interest for a variety of applications. The system processes cartridges containing arrays of oligonucleotides attached to a glass substrate.
Moffitt said in the call that Nanosphere finished collecting samples and follow-up data on enrolled patients in the fast-track trial at the end of December. Samples from the trial are now at the core lab site that will run the assay to generate the data. "We will coordinate with that center to distribute to two additional sites. FDA likes to see three or more sites for 510(k) submission," he said.
According to Moffitt, Nanosphere plans to use data taken in parallel with the fast-track trial to look at acute myocardial infarction and risk stratification of acute coronary syndrome.
"We have a parallel process with fast-track. It's a stand alone pivotal trial with very specific endpoints that deal with improved diagnosis of AMI and better risk stratification of acute coronary syndrome," he said.
Moffitt said that Nanosphere is on track to run the samples this summer. That process will take about three months, which means the company will be three or four months away from filing with the FDA once the sample analysis begins.
Moffitt also said the company plans to pursue what he called "the big step two with troponin," which is a chronic heart failure application.
"We not only see an opportunity in the acute care setting where early data have already demonstrated earlier detection of acute coronary syndromes, but we've also begun to demonstrate a new application in the monitoring of patients with chronic heart failure," he said in the call.
"Initial results have now been confirmed with a follow-on study and we are considering the approach and timing for a pivotal trial to fully underwrite this new application."
In the meantime, the company plans to do additional testing of the troponin test against one or two industry standard assays "just to show the time differential," Moffitt said.
"At the end of the day if someone is having a coronary, every assay out there is going to catch it at some point. The value of a more sensitive assay is that you catch it earlier," he said. Another benefit, he noted, is the test's negative predictive value — "the ability to rule out high-risk patients who aren't having a heart event and move them out of the emergency setting."
Moffitt said that this feature should be "very valuable in chronic heart failure where some early studies have already shown [that] without our level of sensitivity, you can't pick up all those patients."
Regarding a timeline for expanding the assay to chronic heart failure applications, Moffitt said Nanosphere won't be putting too much into it until the test is FDA cleared for ACS and AMI applications.
"Let's get this assay cleared by the FDA first," he said. "That doesn't mean we won't get started on setting up the trials, but the right way to think about it is we're going to get this assay cleared for ACS and AMI application first, then move on to deal with chronic heart failure."
In addition to the cardiac troponin I assay, Moffitt said Nanosphere hopes to have its CYP 2C19 test approved later in 2011. Nanosphere filed a pre-market approval submission with the FDA for the 2C19 assay in 2010. In addition, the company's gram+ version bloodstream infection assay is in clinical trials in preparation for submission to FDA and CE mark later this year, and its enteric pathogen panel is in development, on schedule to be commercialized in 2012.
"In terms of Plavix metabolism, 2C19… the process of exchange [with the FDA], follow ups, manufacturing protocols, all of that has increased," Moffitt said in the call.
"We've said before that the last step is an onsite inspection. Once the FDA gets to the point where they're ready to schedule that, we'll be able to more accurately target a timeframe for approval. But that has not been scheduled," he said.
Earlier this month, Nanosphere announced it had received CE-IVD marks for three of its array-based tests, its Respiratory Virus Plus Nucleic Acid Test, its CYP 2C19 Nucleic Acid Test for clopidogrel metabolism, and its Warfarin Metabolism Nucleic Acid Test, all of which run on the Verigene platform.
Initially the launch of the three CE-IVD marked assays has been limited to a handful of European countries — Italy, Portugal, Spain, Switzerland, and Turkey (BAN 4/19/2011). In the call last week, Moffitt said the fragmented approach reflects the fact that Nanosphere has been marketing through country-specific distributors.
"We have our initial distribution agreements executed and will roll out by country… through the rest of this year," he said.
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