MicroPhage opens clinical trial on microphage-based platform to
1 September 2009
MicroPhage has launched a multi-site clinical trial to support a US
FDA premarket notification [510(k)] for its bacterial identification
platform based on bacteriophage amplification. The platform has been
developed to rapidly identify bacterial infections and determine
antibiotic susceptibility or resistance to aid physicians in antibiotic
The company’s first product is designed to rapidly identify
Staphylococcus aureus (staph) bacteria and determine methicillin
resistance (MRSA) or susceptibility (MSSA) in suspected cases of
bacteremia — bacteria in the blood, in as little as 5 hours. Today’s
standard of care for determining these types of infections takes up to
The MicroPhage test platform requires no instrumentation and is
composed of two small reaction tubes for incubating blood culture
specimens. After five hours, the incubated samples are added to a dual
dipstick-like detector, which looks much like a pair of home pregnancy
tests. One part of the detector shows if the sample is infected with
S. aureus bacteria and the other shows if it is susceptible or
resistant to the antibiotic.
The MicroPhage S. aureus / MRSA / MSSA blood
culture test kit.
(Photo: Business Wire)
Results allow for more precise antibiotic therapy for a condition
that has a mortality rate of 20% or more. Delivering this diagnostic
information quickly will enable physicians to prescribe more effective
and precise antibiotics that could shorten hospital stays, lower rising
health care costs, and ultimately save lives.
The study will involve seven major medical centers throughout the US
and is expected to test more than 2,000 specimens to demonstrate its
safety and performance. The MicroPhage test will be compared to a
laboratory 'gold standard' test to determine performance. It is expected
to be completed in the fourth quarter of this year.
“This is a very exciting time for our company,” said MicroPhage CEO,
Steve Lundy. “We are excited about our prospects to provide health care
providers with rapid, actionable information to fight the rising tide of
hospital acquired infections while lowering health care costs. We look
forward to this Trial and getting to market later this year.”
About the MicroPhage technology
MicroPhage has adapted bacteriophage-amplification, a natural
biologic process, for identifying bacterial infections. Bacteriophage
are harmless bacteria-specific viruses that multiply aggressively when
exposed to target bacteria.
Major Parts of a Lytic Bacteriophage.
(Graphic: Business Wire)
In the detection process, reaction of the bacteriophage proteins on
the test strip indicates the sample is positive for staph bacteria. For
susceptibility analysis, the organism in the sample is challenged with
Because bacteriophage depend on host bacteria for amplification, any
compound that kills or inhibits the microbe will stop phage
amplification. Only strains resistant to the antibiotic allow this
amplification and yield a positive signal on the second detector strip,
indicating an MRSA infection.
About Staph infections
Staphylococci are frequently implicated in bloodstream
infections (BSI) with high morbidity and mortality. In a multinational
study, 36% of bloodstream isolates were staphylococci, 61% of which were
In a prospective cohort of patients with hospital-acquired BSIs in
the United States, S. aureus was a primary cause, accounting
for 20% of cases. The incidence of S. aureus bacteremia has
increased significantly over the past decade, largely due to the
increasing use of intravascular catheters and invasive devices.
There has also been a significant rise in rates of methicillin-resistant
S. aureus (MRSA). Almost 60% of S. aureus bacteremias
in the United States are now caused by these resistant strains. Despite
advances in medical therapy and diagnostic procedures, S. aureus
bacteremia is often associated with serious complications with a
mortality rate that exceeds 20%, especially if appropriate therapy is
not administered rapidly.
A rapid and reliable test for this diagnosis would allow clinicians
to optimize diagnostic and therapeutic decisions. Antibiotic therapy
could be adjusted early, leading to better health outcomes for patients
with lower pharmacy and hospitalization costs.
Diekema DJ, Schmitz FJ, Pfaller MA, Bell J, Smayevsky J, Beach M,
Jones RN, and the SENTRY Participants Group. Survey of infections due to
Staphylococcus species: frequency of occurrence and antimicrobial
susceptibility of isolates collected in the United States, Canada, Latin
America, Europe, and the Western Pacific region for the SENTRY
antimicrobial surveillance program, 1997–1999. Clin Infect Dis
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