The issue of methicillin-resistant S. aureus may have taken a backseat to current reports of H1N1, but the spread of this antibiotic resistant bacterium is still prevalent and continues to be a strong market, according to MicroPhage (Longmont Colorado) – a small startup company developing rapid diagnostic tests.
The company said that it makes a transition of sorts this week as it finally receives CE mark approval to sell its Microphage MRSA/MSSA Blood Culture Test designed to rapidly identify Staphylococcus aureus bacteria as well as determine methicillin resistance (MRSA) or susceptibility (MSSA) in suspected cases of bacteremia bacteria in the blood in as little as five hours.
'We consider [getting the CE mark] a major milestone, Steve Lundy MicroPhage, CEO told Medical Device Daily. "With the ability to now market our product in Europe, we're now a commercial company as opposed to a developmental company."
Since its inception in 2003, MicroPhage has been vying for the commercialization of its diagnostics tests. Armed with only 16 employees, a number that is soon sure to grow, MicroPhage is now reportedly eyeing to get a foothold into the U.S. market.
The company has already had some exposure in the states. In August, it reported the start of a multi-site clinical trial to support its FDA premarket notification 510(k) submission, which is expected to be filed shortly. The clinical study involves four major medical centers throughout the U.S. and is expected to test more than 1,000 specimens with the Microphage MRSA/MSSA Blood Culture Test to demonstrate its safety and performance.
"Our initial product, as well as the family of tests we intend to offer based on our Bacteriophage Amplification platform, represents a new paradigm for the effective, cost-effective testing of hospital patients," Lundy said.
The test itself requires no instrumentation and begins with two small reaction tubes for incubating blood culture specimens.
After only five hours, the incubated samples are added to a dual dipstick-like detector, which looks much like a home pregnancy test. One part of the test will identify if the blood sample is infected with S. aureus bacteria and the other shows whether it is susceptible or resistant to methicillin-type antibiotics.
Delivering this diagnostic information quickly will enable physicians to determine more effective and precise antibiotics that could shorten hospital stays, lower healthcare costs and, ultimately, save lives. S. aureus bacteria typically has a mortality rate of more than 20%.
Another upside according to MicroPhage, is that the results derived from the assay cost about $15-$40 per test –significantly lower than some other tests on the market.
With the anticipation of getting into the regulatory path from the FDA and riding off the coat tails of the CE mark, Lundy said the company is poised to raise nearly $15 million in financing.
"Because of the amount of money we've raised in the past and where we're at in the regulatory pathway, I would say this is like a hybrid B and C series financing," Lundy said. "We didn't go the traditional VC route; most of our money was raised from private investors."
MicroPhage last reported completing a financing round that brought the total money secured for the company up to $11 million (Medical Device Daily, Nov. 24, 2008).
Lundy said that he isn't concerned about raising the required capital for the next financing round, because the issue of MRSA is still a big problem that many hospitals face.
"Hospital-acquired infections (HAIs) are a colossal problem, killing more than 15 million persons worldwide each year and costing the U.S. $29 billion in unnecessary healthcare expense. We believe that our initial test will be extremely well received in Europe as well as in the U.S., " Lundy told Medical Device Daily. "MRSA is still here and it's still a prevalent issue."
Omar Ford, 404-262-5546;