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."
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.
Lynn Yoffee, 770-361-4789;