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Q3 2010 Earnings Call
November 3, 2010 5:00 p.m. ET
William P. Moffitt III - Chief Executive Officer
J. Roger Moody Jr. – Chief Financial Officer
Michael K. McGarrity - Chief Marketing Officer
Bill Quirk - Piper Jaffray
Scott Gleason - Stephens
Kelly - Jefferies & Co.
Good day, ladies and gentlemen, and welcome to the Third Quarter 2010 Nanosphere Incorporated Earnings Conference Call. [Operator Instructions.]
Previous Statements by NSPH
» Nanosphere, Inc. Q2 2010 Earnings Call Transcript
» Nanosphere, Inc. Q1 2010 Earnings Call Transcript
» Nanosphere, Inc. Q4 2008 Earnings Call Transcript
» Nanosphere, Inc. Q3 2008 Earnings Call Transcript
Because these forward-looking statements involve known and unknown risks and uncertainties, there are important factors that could cause actual results, events or developments to differ materially from those expressed or implied by these forward-looking statements.
Such factors include those described from time to time in Nanosphere's filings with the United States Securities and Exchange Commission. Please note that Nanosphere undertakes no duty to update this information.
I would now like turn the presentation over to your host for today’s conference, Mr. Bill Moffitt, CEO. You may proceed.
Thank you, operator. Good afternoon everyone and thanks for joining us for Nanosphere’s investor conference call covering the third quarter of 2010. In a few moments I’ll turn the call over to Roger Moody, Chief Financial Officer, and Mike McGarrity, Chief Marketing Officer. But first let me give you my perspective on our progress toward near term milestones that will drive growth over the next several quarters.
We continue to make significant progress towards expending our test menu and the markets we serve. Our goal is to build a global molecular diagnostics company by creating customer and shareholder value through menu expansion and the greater functionality and applicability of our Verigene system.
To achieve our goal, we're focused on addressing three primary market needs. One, enabling the conversion of microbiology to molecular methods, where century-old test methods result in lengthy delays to appropriate therapy, increasing patient risk and the cost of care. Two, providing point of care pharmacogenetic solutions ensuring that the right drug gets to the right patient in the right dose when and where the patient is seen. And three, enabling an earlier detection of this disease through ultra-sensitive protein assays.
Now let me spend a few moments on the progress we're making in each of these key areas. Hospital-based microbiology labs have already begun the conversion to molecular methods. As we have seen historically with virology, single-target assays have been the norm, as underlying technologies are limited in ability to perform complex, broad panels, a limitation we do not have with our nanoparticle-based micro-array platform.
Hospitals need simple, cost-effective systems that can answer broad diagnostic questions by identifying any number of suspected infectious agents. The Verigene SP and our pipeline of infectious disease assays directly address this need.
The first example is our respiratory assay that was cleared on the Verigene SP in the fourth quarter of last year. Since then, we've added subtyping for influenza A. This test includes influenza A, influenza B, RSV A&B, and subtyping for seasonal H1, seasonal H3, and the 2009 novel H1N1, or Swine Flu as it became known.
We have submitted this test to the FDA for 510(k) clearance, and upon clearance we are prepared to commence product shipment to the market this flu season. We expect this new respiratory assay will be the only panel to include all of these targets in a single test and run on a sample-to-result platform.
With continued focus on hospital-acquired infections and the need to quickly identify the underlying bacterial cause of sepsis, there is increasing demand for a broad panel of blood-borne pathogens on a molecular platform that can provide rapid turnaround time, cutting definitive diagnosis and selection of appropriate antibiotic therapy from days to hours. We remain on track to initiate clinical trials for the gram-positive panel near the end of this year. This panel will be followed by gram-negative and fungal panels.
Our microbiology development efforts also include C. difficile and other enteric bacteria assays. The C. difficile test we plan to develop includes both the genetic test to detect the presence of C. difficile and toxin B, a protein test that indicates whether the virus is active.
C. difficile is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. We have demonstrated feasibility of running the genomic and protein assays in combination on the same sample, and will move on to full-scale development of this assay in 2011.
Beyond the C. difficile assay, we plan to develop an enteric bacteria panel to detect and identify pathogens that most often result from food poisoning. This panel tests for a wide spectrum of bacteria that are treated with various antibiotics and other antibacterial drug therapies.
We are confident that this comprehensive pipeline of molecular based tests addresses the breadth of test panels, ease of use, and rapid turnaround needs facing the microbiologist today.
Turning for a moment to the area of human and pharmacogenetics, we are also making significant progress. In the third quarter we filed a PMA with the FDA for our 2C19 assay used to guide antiplatelet therapy using clopidogrel, more commonly known by the brand name Plavix. Since filing the clopidogrel PMA application in the third quarter, we've received confirmation from the FDA that they have granted expedited review status.