MEDICAL DEVICE INNOVATION - Medical Device Daily

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86 Molecular Detection prepares to launch quick MRSA test By LYNN YOFFEE Medical Device Daily Staff Writer Molecular Detection (MDI; Wayne, Pennsylvania), a new player in the molecular diagnostics field, is preparing to launch the Detect-Ready assay for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) as it just completed a $3.3 million Series C financing. The company purports advantages of its test that offer a quicker, more streamlined process with kits that are both preloaded with a gel containing all of the chemicals required for DNA-probe testing and the ability to deliver the product at room temperature. To date, the most widely used test to check for MRSA, a staph infection that’s resistant to common antibiotics, is a culture that can take one to two days. MDI’s test will produce results in under two hours. “Like the culture tests, we also are a nasal swab-based kit, but we’re really moving to an off-the-shelf test that changes the paradigm,” MDI CEO Todd Wallach told Medical Device Daily. “This uses PCR and gene amplification in a rapid fashion. We can detect very low samples of MRSA.” MDI is preparing to submit a 510(k) application to the FDA, but has already obtained CE mark in Europe for the Detect-Ready assays which is where the product will be launched first. It was both the near-term promise of MDI’s MRSA assay and the company’s potential with other molecular diagnostics that contributed to MentorTech Ventures’ decision to lead the Series C financing, according to Boris Kalandar, managing director of MentorTech Ventures and a board member of MDI. “The fact that the financing was significantly oversubscribed in a challenging market attests to investors’ enthusiasm for MDI’s approach.” Wallach was also just named CEO of this two-year-old company, spun out of Syntezza Bioscience (Jerusalem). But now MDI is to be the parent company while Syntezza will become the subsidiary, focused on R&D. “We anticipate launching the Detect-Ready assay for MRSA test later this year in Europe,” Wallach said. “This Series C financing represents a major milestone for MDI, confirming the promise of our innovative molecular diagnostic technologies and our soon-to-be-launched assay for MRSA screening. The Detect-Ready MRSA assay offers healthcare providers a high-performance diagnostic with an unmatched combination of accuracy, speed, flexibility and cost-effectiveness, addressing a market that is expected to exceed $1 billion in annual revenues in the next few years. We are gratified at the strong investor response to this financing, which provides the resources needed to launch our MRSA assay in Europe and the U.S. while also expanding our pipeline of molecular diagnostic tests.” MEDICAL DEVICE INNOVATION 2010 In addition to MentorTech Ventures as lead for the offering, which was more than 300% oversubscribed, other investors included Ben Franklin Technology Partners, Robin Hood Ventures and the Mid-Atlantic Angel Group Fund I and II. MDI was previously funded by private investors and the company’s founders. Wallach just joined MDI after being CFO at Aton Pharma (Lawrenceville, New Jersey). The founder and president of MDI’s Israeli subsidiary, Aryeh Gassel, PhD, noted that the completion of the financing along with recruiting Wallach marks a turning point for the young company from development to commercialization. The staph infection test is expected to be a game changer because it’s easier to use and doesn’t require refrigeration. “There are other MRSA tests on the marketplace,” Wallach said. “But we believe the current tests require lots of preparation and work. Our test is designed to be [used] off the shelf. We will minimize operator and technician time,” he said, adding that the price will be competitive with others on the market. “It’s important to note our final confirmatory clinical studies are ongoing,” Wallach said, adding that those data will be available when the company submits its 510(k) application. (This story originally appeared in the Oct. 1, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 Nanosphere submits 510(k) for rapid, POC influenza test By LYNN YOFFEE Medical Device Daily Staff Writer If FDA cleared, Nanosphere’s (Northbrook, Illinois) new respiratory test to run on the Verigene SP may offer the kind of point-of-care diagnostic needed for a potential H1N1 pandemic. The company this week submitted a 510(k) application to the FDA for its influenza and respiratory syncytial virus (RSV) test to run on the Verigene SP, with complete sampleto-result automation in one device, avoiding the need for complex PCR testing and reference labs. “The technology is based on gold nanoparticles that are turned into probes by functionalizing the surface of them with oligonucleotides,” William Moffitt, Nanosphere’s president/CEO told Medical Device Daily. “As it turns out these gold nanoparticles exhibit an extraordinary degree of specificity. It’s cost effective and easy to use. All of this can be packaged into a single-use disposable test cartridge. The only thing the user needs to do is to put the sample in, which is a nasal swab or nasal wash.” Verigene is a random-access, molecular diagnostic workstation for nucleic acid and protein diagnostics, and is FDA-cleared for in vitro diagnostic (IVD) use with specific Verigene tests. Verigene SP is a newer version of the benchtop workstation that provides automated sample-to-result molecular diagnostics capabilities in a multiplexed, random-access, modular system using the same imaging technology as the first generation Verigene. “The most important thing is the sample-to-result feature in one instrument,” Moffitt said. “And it’s random access, so there’s no batch processing. Most other assays on the market are batch-processed with a significant number of steps. It’s just not cost effective to go to that effort for one assay. But with Verigene SP you can run one assay as inexpensively as you can run 100. “Think about taking a PCR-based reaction and multiplexing it,” he said. “That’s what the industry has been doing. You’ve got to go to some post-PCR device to multiplex. But those probes lack a degree of specificity inherent in gold nanoparticles.” The test takes about three hours to produce results, but Moffitt said the company is continuing to shorten that time frame. The respiratory assay just submitted for FDA review is designed to test for all sub strains of flu, including detection of H1N1, “But we can’t make that claim until FDA clears it,” he said. When asked if Nanosphere requested an expedited review of the new assay given the looming H1N1 pandemic, Moffitt said, “You can request an expedited review, but my experience is that they are treating all of them (tests for flu) as expedited reviews because of the potential for a flu pandemic.” With its commercialization of Verigene SP and the new respiratory assay, Nanosphere is doing more than introducing just another quick test – it’s attempting to alter the molecular testing landscape and offer a test that rivals PCR accuracy, but at point of care. “If you think about a central hospital-based lab today and the kinds of tests they run and the rest of services in that hospital, the systems are highly centralized. In general molecular testing has been highly centralized and it needs to be decentralized into the average community hospital,” Moffitt said. “These molecular diagnostic labs are highly complex, but the market would benefit from a technology that’s simple and can be decentralized.” As it stands now, a regional medical center may include a half a dozen clinics or more. Given a flu pandemic, the samples would have to be taken at clinics and then transported to the hospital labs to be run later or the next day. “A diagnosis would have to be made in absence of that information,” he said. “The Verigene system has simplicity of operation and you could put these systems in those clinics. It would move molecular diagnostics closer to patients and move infectious disease assays to point of care for more timely diagnoses.” If the FDA grants clearance, Moffitt said the company will turn to the task of gearing up production for instruments and test cartridges. He declined to provide production estimates or turnaround if the world faced an H1N1 crisis. “It would be a reasonably short time frame, adding staff and shifts of labor for production processes,” he said. Verigene SP is priced at $20,000 and sample processing modules can be purchased individually. After being on the market for just two years in the U.S., Moffitt said no units have required replacement and he estimated the machines would last for “years.” (This story originally appeared in the Aug. 26, 2009, edition of Medical Device Daily) 87 To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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