Market - Blood Culture

Current methods to detect bacteria from blood in cases of suspected bacteriemia, septicemia, and fevers of unknown origin often take two to five days, much too long for these diseases where mortality rates can be as high as seventy percent. MicroPhage believes that rapid identification of bacteria in a few hours following a positive blood culture could greatly impact the mortality rate of these patients, allow for more appropriate antibiotic therapy, and reduce hospitalization costs. With this application, physicians would be able to "rule out" often contaminating bacteria, while narrowing the focus of therapy for those organisms which are present and appear to be pathogens.

MicroPhage's first product addresses the need for more rapid bacterial identification in identifying bacteria in blood cultures. It can take as much as five days to identify bacterial organisms from patients suspected with bacteremia or sepsis. At the core of the diagnostic problem is the need to isolate a pure culture of the present bacterium after identifying microbial presence by blood culture. MicroPhage believes that within four hours of a positive blood culture alarm, bacterial identification can be made for select organisms, and within four to six hours, drug sensitivity can be determined. This represents a net savings of 3 - 4 days over many standard protocols and directly impacts clinical care.

MicroPhage will take advantage of the potential product attributes including speed, ease of use and sensitivity, by incorporating our technology into one of its first blood culture product development programs. The product will significantly reduce the time necessary to detect Staphylococcus aureus after a blood culture positive alarm.

Existing Rapid Methods - Detection from Subcultue

Many rapid methods are used to identify organisms almost absolutely (within 1-2%) while saving 8 - 12 hours for biochemical analysis on automated instruments downstream. Although there is time savings in identifying organisms at this point in the process, these rapid methods require isolation of the bacteria from the blood culture and grown to significant numbers in order to be this effective. This results in assays so far along from the blood culture positive (15 - 18 hours) and the original time of collecting the blood sample (30 - 48 hours); their clinical utility is often questioned.

Direct Detection

Aiding clinicians with more definitive results and taking advantage of this window of opportunity, a number of technologies have been described to directly identify these bacteria from the blood culture positive sample. Those with the most success have been molecular technologies, which amplify a unique nucleic acid segment of the target organism for identification, or take advantage of large concentrations of specific sequences present in the blood culture positive sample. Although these technologies have been described with significant results, only the PNA FISH assay from AdvanDx has been cleared for direct detection by the FDA for this specific use. The RT-PCR platform developed by IDI and GeneOhm Sciences (now BD DIagnostics) has recently (April 2007) submitted a premarket application (510k) to the FDA for this indication.

Simple, Rapid, and Accurate

Unlike many of these methods, with requirements of subculturing, special equipment or highly skilled technologists, the MicroPhage approach is simple, straightford, and produces equivalent results.

Getting to results direct from a sample has never been so straightforward.