By Ben Butkus
Molecular Detection said this week that it has completed a $1.5 million financing to advance commercialization of its Detect-Ready molecular diagnostic panels for detecting sepsis and gastrointestinal diseases.
The company said that it has commenced beta testing for both panels at several undisclosed healthcare facilities in Europe and Israel, with the goal of obtaining CE Marking for the products this year and seeking approval from the US Food and Drug Administration in 2013, CEO Todd Wallach told PCR Insider.
In addition, MDI said this week that it has received a new European patent for its reagent-stabilization technology, which enables it to ship its molecular diagnostic kits at room temperature without compromising the integrity of the PCR-based chemical reaction.
"We intend for both of these products to be CE Marked this year, and then to move into the US in the 2013 timeframe," Wallach said. "So our strategy with these products is to release them in Europe, and in parallel start the process with FDA."
All of MDI's existing investors, including MentorTech Ventures, Robin Hood Ventures, Elm Spring Holdings, and the Mid-Atlantic Angel Group, participated in the $1.5 million financing. MDI previously raised $1.4 million in June 2010 on top of a $3.3 million Series C financing round in late 2009.
MDI, which is based in Wayne, Pa., with additional offices in Tunbridge Wells, UK, and Jerusalem, Israel, already markets one Detect-Ready panel for detecting and discriminating between methicillin-resistant Staphylococcus aureus, methicillin-sensitive S. aureus, and related organisms.
The company markets Detect-Ready MRSA in the EU and other territories outside the US. The company has staggered its rollout of the product, introducing it in March 2010 in Germany, Austria, and Switzerland through distributor Inverness Medical Deutschland (PCR Insider, 3/30/10); and in May 2010 in the UK, France, and Ireland through UK-based Launch Diagnostics (PCR Insider, 5/19/2010).
MDI has also inked exclusive distribution pacts with Integrated Sciences to distribute Detect-Ready MRSA in Australia; with Eldan for Israel and the Palestinian territories; and with Palex Medical for Spain.
This week, the company said in a statement that Detect-Ready MRSA is in "late-stage development" in the US. "Our 510(k) testing [for Detect-Ready MRSA] is in process, and we expect to release more information about that later this year," Wallach elaborated.
All of MDI's Detect-Ready tests are based on qualitative real-time PCR and are designed to run on existing real-time PCR platforms, including the Roche LightCycler, Qiagen Rotor-Gene, and Cepheid SmartCycler.
In addition, all of MDI's tests use four proprietary technological improvements: "stabilization, chemistry, our differential diagnosis engine, and our PCR algorithms," Wallach said.
"Our stabilization platform is unique in the field because it allows for non-cold chain shipping, which is of great value [for administering the test] around the world," Wallach said. "Plus it leads to true off-the-shelf usage, where we can literally pre-mix our reactions and they're ready to use by just putting in the sample."
The company said this week that it recently received allowance of a new European patent covering the stabilization technology.
Meantime, the company's real-time PCR chemistry, which is proprietary and patent-pending, allows for "very efficient" PCR reactions that "minimize all primer-dimer and non-specific products," Wallach said. "That allows us to highly multiplex and basically create panels in one tube. This changes the paradigm, for example, in a 96-well plate, where you usually have a target in each well — we will have all the targets in one well."
Third, MDI's "differential diagnosis" engine allows users to "assess the PCR amplification rates of multiple targets from both DNA and other genetic targets," Wallach said. "Not only that, it allows us to differentiate the targets and whether they're coming from one source, or one pathogen; or a second pathogen."
This capability is important, he noted, in many infectious disease diagnostic areas — particularly when detecting MRSA, sepsis-causing pathogens, and gastrointestinal pathogens — "because there are quite a few pathogens that begin to look alike when they are in a mixed sample," Wallach said.
"This allows us to determine whether that target is coming from one bug or two bugs," he added. "For example, that very heavily changes a MRSA diagnosis, because there are a lot of things that look like MRSA combined in real samples, and we've seen this in all our patient samples and trials to date. The ability to distinguish those is what we bring to the table, and this is what increases positive predictive values."
Other early-stage molecular diagnostic developers have similarly developed technology to address this issue. In particular, US-based startup Great Basin recently published a study demonstrating 99 percent accuracy for its automated DNA assay panel to identify major pathogenic strains of Staphylococcus and methicillin resistance in blood culture (see story, this issue).
MDI this week also highlighted a recent study vetting its MRSA panel. Specifically, in September at the Institute for Biomedical Science annual conference in the UK, researchers from St. Thomas' Hospital in London presented a poster demonstrating superior sensitivity of Detect-Ready's MRSA test with that of Becton Dickinson's PCR-based GeneOhm MRSA kit, a well-established marketed product.
That study, among others, Wallach said, has "proven our platform across the board for all of these technologies to lead to a pure sample-to-answer solution." Wallach did not know whether the study had been submitted for publication in a peer-reviewed journal.
Lastly, MDI's proprietary "PCR algorithms" describe software that allows users to interpret differential PCR amplification rates and compare across targets.
"We provide a software tool as part of our kit that allows the laboratory technician and clinician to see the results. Basically, the PCR machine runs … and we take the data that's produced the amplification rates, and we run it through our software. In fact, in several applications our software actually runs the machine, so all the researcher would do is press play … and the whole PCR process from sample to answer begins."
Detect-Ready MRSA measures three separate genes associated with S. aureus and antibiotic resistance, allowing it to simultaneously detect MRSA, MSSA, and methicillin-resistant non-S. aureus pathogens, as well as mixed samples.
Wallach said that the company's sepsis and gastrointestinal panels will be "more significantly multiplexed;" however, he said that MDI has not yet disclosed specifics.
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