Being hospitalized for anything is traumatic to most people; the insult and threat on top of that is the hospital-acquired deadly infection known as methicillin-resistant Staphylococcus aureus (MRSA). Current diagnostic techniques take days. Newcomer MicroPhage (Longmont, Colorado) has just submitted human data from a pivotal clinical study of its MRSA/MSSA (methicillin-sensitive Staphylococcus aureus) Blood Culture Test to support FDA 510(k) clearance of the test that produces results onsite in five hours.

The first of MicroPhage's instrument-free, rapid tests is based on the company's patented bacteriophage amplification platform technology.

"It's very exciting for us as the first product. We've already got our CE mark and we have already begun selling in Australia. We're pleased to turn the corner," Alene Campbell, the company's new CEO told Medical Device Daily. "The main implication is that now that this technology is applied to this pathogen, we know we can do it over and over again for the next bacteria." (MDD, Dec. 7, 2009)

Campbell last week just stepped in as CEO after Steve Lundy resigned to pursue other opportunities. She has served as MicroPhage's COO for two years.

The company's secret sauce, bacteriophage amplification, produces a specific and highly antigenic marker to identify the presence of viable bacteria and their response to antibiotics. This process offers the ability to increase specificity and decrease time to results on existing immunodiagnostic platforms. Unlike molecular testing, phage amplification doesn't demand technical expertise or special equipment.

"It's like a pregnancy test," Campbell said. "This is the first rapid test for susceptibility. It tells physicians what drugs they can give, not just what won't work. Our study showed very good positive predictive value."

She explained that humans carry millions of copies of bacteriophage, which are bacteria-specific viruses. Bacteriophages work to replicate in the presence of specific bacteria. MicroPhage's technology works because specific bacteriophage are introduced to the processed sample, where they find, infect, and amplify their target pathogen(s) providing a very specific, highly amplified surrogate marker for rapid detection.

Bacteriophages selectively infect targeted bacteria and rapidly multiply. The system can generate as much as a 5-log amplification of signal. This allows for reduced incubation times, resulting in complete assay times of one to four hours compared with traditional culture assays of 24 to 48 hours.

"The platform itself is a breakthrough," Campbell said. "It works for E. coli, salmonella . . . any of the Gram negatives. There's a tremendous problem in infectious disease. Bacteria continue to become resistant to new antibiotics. You have to know quickly which drug will work to avoid giving drugs indiscriminately. Current diagnostics haven't been quick enough.

She pointed out that 1.7 million hospital-acquired infections occur each year and 100,000 people die, primarily due to the slowness of current testing methods.

The Microphage MRSA/MSSA Blood Culture Test begins with two small reaction tubes for incubating blood culture specimens. 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 health care costs and, ultimately, save lives. S. aureus bacteria typically have a mortality rate of greater than 20%.

Data submitted to the FDA has yet to be published. But Campbell said, "We have exceeded FDA requirements for labeling for an aspartate aminotransferase [AST] system. We are pleased with results. It has high positive predictive value. We feel physician will have confidence in those results."

Each test costs $30 and reimbursement codes are already in place.

Meanwhile, Campbell said MicroPhage is busy with fundraising efforts to accommodate their first product rollout through venture capital, investment banks and private individuals.

"We've been very fortunate to have a group of internal investors who have funded us until now," she said. "We've got cash to last four more months, but to do a good job, we need more."

MicroPhage last reported completing a financing round that brought the total money secured for the company up to $11 million (MDD, Nov. 24, 2008).

Lynn Yoffee; 770-361-4789
lynn.yoffee@ahcmedia.com