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August 20, 2009 01:10
PM Eastern Daylight Time MicroPhage
Opens Pivotal FDA Study on Bacterial Identification Platform
Source of Article: http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20090820005851&newsLang=en LONGMONT,
Colo.--(BUSINESS WIRE)--MicroPhage
announced today the launch of its multi-site clinical trial to support a U.S.
Food and Drug Administration (FDA) premarket notification [510(k)]. The
platform has been developed to rapidly identify bacterial infections and
determine antibiotic susceptibility or resistance to aid physicians in
antibiotic management. 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 three days. 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. 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 country 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. 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 an
antibiotic. 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. Further information about the technology is
available at www.microphage.com/technology. 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 Staphylococcus aureus. 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 2001;32:S114–S132 About
MicroPhage, Inc. Based in
Longmont, Colorado, and privately held through a network of angel investors,
MicroPhage, Inc. is working to be a global leader in developing rapid
diagnostics products for bacterial identification and antibiotic
susceptibility/resistance testing. Using its proprietary bacteriophage-based
amplification platform, the company has developed a patented process that is
a product platform for rapid, easy-to-use, inexpensive diagnostic tests. The
technology platform resembles a pregnancy test with twin rapid detectors. The
platform does not require any instrumentation and is easy to operate,
enabling microbiology testing outside of traditional laboratory settings. The company’s
first products will set a new standard for clinicians in S. aureus
identification and antibiotic susceptibility testing, and are designed to fit
the demands of hospitals and laboratories of all sizes. Other tests in
development include rapid tests for screening, skin and soft tissue
infections, and respiratory infections for S. aureus and other
bacteria of clinical interest. For further information, go to www.microphage.com. Photos/Multimedia
Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6033891&lang=en.
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