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Please Note: The technology listed below is not available to the public at this time. This technology is in the early stage of research and requires further development before it is ready for the marketplace. The VA is currently in the process of identifying potential companies who may be interested in licensing and/or further developing the technology through Cooperative Research and Development Agreements (CRADA). Through cooperative research initiatives such as these, it is our hope and goal that commercial products will be fully developed and made available to benefit veterans and others.
VA TECHNOLOGY OPPORTUNITY BRIEF
Pseudostat II
OPPORTUNITY:
The Department of Veterans Affairs (VA) is seeking a commercial partner to further
develop this technology through a Cooperative R&D Agreement (CRADA) to expedite
bringing it to market.
BACKGROUND:
Pseudomonas aeruginosa is a Gram-negative bacterium that is versatile in its
habitat and can grow in soil, water, and on plant and animal tissue. An opportunistic
organism and one of the most problematic nosocomial pathogens, it is capable
of causing disease in susceptible individuals such as people who have cystic
fibrosis, cancer, burns, or some immune system deficiency. Case fatality can
be as high as 50 percent due to a combination of weakened host defenses, bacterial
resistance to antibiotics, and the production of extra cellular-bacterial enzymes
and toxins. P. aeruginosa often colonizes hospital food, sinks, taps, mops,
and respiratory equipment. The infection is spread from patient to patient via
contact with fomites or by ingestion of contaminated food and water.
P. aeruginosa is clinically indistinguishable from other Gram-negative bacteria
that also cause these sorts of infections but that have a lower morbidity and
mortality rate. Therefore early and accurate diagnosis is important. This is
particularly so as P. aeruginosa is well known for being resistant to a wide
spectrum of antibiotics. Healthy individuals who come into contact with people
with P. aeruginosa infections are not at risk of developing the infection themselves.
In fact, P. aeruginosa is a resident of the intestinal tract in about 10 percent
of healthy individuals, and is found sporadically in moist areas of the human
skin and in the saliva.
The major clinical features used in diagnosis in situ are pus formation, pyocyanin
formation in about 90 percent of cases, and fluorescein formation, which can
be viewed in the dark with a Wood's UV light for fluorescence. There are 13
antigenic groups of P. aeruginosa, which in the future, may be treated differentially
with immunotherapy. This bacterium can be distinguished from other pseudomonad
strains by growth at 42° Celsius.
TECHNOLOGY OVERVIEW:
The subject technology is an antibody-based test that is able to identify
the bacterium Pseudomonas aeruginosa in clinical specimens. The technology constitutes
a test kit with necessary reagents and tools, a reagent mixture formula, and
a method of preparing reagents and performing test. The bacterium is responsible
for bed ulcers, urinary tract infections, pneumonia, burn infections and blood
and skin infections. At present, diagnosis of the organism takes 46 to 48 hours
to perform. The subject technology is able to reduce the test turnaround time
to 18-20 hours and is a single assay as opposed to a battery of tests. A sample
is taken from the patient (sputum, urine, blood or from the wound) and the bacterial
colonies are grown in culture for 18 to 24 hours. An antibody that is specific
for a lipoprotein (LP1) on the surface of P. aeruginosa is incubated with the
sample and an agglutination reaction is used to indicate a positive result.
TECHNICAL MERIT:
The current test for P. aeruginosa is based on biochemical analysis and takes
46 to 48 hours to perform. The nature of the test means that the diagnosis is
never definitive but provides a profile that can be said to be most similar
to P. aeruginosa. The number of biochemical analyses necessary for identification
of a particular isolate is also variable. The subject technology is able to
reduce the laboratory analysis turnaround time by 24 hours, providing diagnosis
the day after the sample is received and consequently allowing antibiotic treatment
to begin a day earlier. This is significant given the morbidity associated with
this infection. The test has a sensitivity of 96 percent and a specificity of
92 percent.
PATENT STATUS:
A provisional patent application was filed on March 21, 2002 (S/N 60/365,812)
An international patent application was filed on March 19, 2003 (PCT/US03/06715)
Federal Register: June 24, 2003 (Vol.68, No.121) p. 37615
US patent application was filed on July 26, 2004 (10/502,464)
FOR MORE INFORMATION CONTACT:
Saleem Sheredos
Program Manager
Technology Transfer Program
Veterans Affairs
Office of Research & Development (12TT)
5th Floor
103 South Gay Street
Baltimore, MD 21202
202-380-5080
Fax 410.962.2141
e-mail: saleem.sheredos@va.gov