[Federal Register Volume 79, Number 23 (Tuesday, February 4, 2014)]
[Notices]
[Pages 6598-6609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02252]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious
commercialization of results of federally-funded research and
development. Foreign patent applications are filed on selected
inventions to extend market coverage for companies and may also be
available for licensing.
FOR FURTHER INFORMATION CONTACT: Licensing information and copies of
the U.S. patent applications listed below may be obtained by writing to
the indicated licensing contact at the Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to
receive copies of the patent applications.
Nucleic Acid-based Compositions and Methods for the Species-Specific
Detection of Pathogenic Candida Fungi
Description of Technology: This invention pertains to the
development of oligonucleotides for the rapid nucleic acid-based
identification of the Candida fungi species C. haemulonii, C. kefyr, C.
lambica, C. lusitaniae, C. norvegensis, C. norvegica, C. rugosa, C.
utilis, C. viswanathii, C. zeylanoides, C. dubliniensis, and C.
pelliculosa within biological samples. This identification is
accomplished by targeting the internally transcribed spacer-2 (ITS2)
region that is specific for each species. The assay is sensitive,
specific and rapid. Implementation of the technology will facilitate
earlier specific diagnoses, and lead to better antifungal therapy
implementation for infected patients.
Potential Commercial Applications:
Directing antifungal drug therapy for improved patient
outcomes
Detection, discrimination of Candida species from
biological samples
Addressing secondary infections of immunosuppressed
individuals
Competitive Advantages:
Easily adapted for use in kits
High-throughput capable
Rapid and cost-effective
Development Stage: In vitro data available
Inventors: Christine J. Morrison, Errol Reiss, Cheryl M. Elie,
Timothy J. Lott (all of CDC)
Publication: Shin JH, et al. Rapid identification of up to three
Candida species in a single reaction tube by a 5' exonuclease assay
using fluorescent DNA probes. J Clin Microbiol. 1999 Jan;37(1):165-70.
[PMID 9854084]
Intellectual Property: HHS Reference No. E-340-2013/0--
PCT Application No. PCT/US1998/015840 filed 30 Jul 1998,
which published as WO 1999/006596 on 11 Feb 1999
US Patent No. 6,242,178 issued 05 Jun 2001
Various international issued patents
Related Technologies:
HHS Reference No. E-293-2013/0
HHS Reference No. E-332-2013/0
HHS Reference No. E-232-2013/0
HHS Reference No. E-335-2013/0
HHS Reference No. E-339-2013/0
Licensing Contact: Whitney Blair, J.D. M.P.H.; 301-435-4937;
[email protected]
Nucleic Acid-based Compositions and Methods for the Detection of
Pathogenic Candida or Aspergillus Fungi Species
Description of Technology: This invention pertains to the
development of oligonucleotides for the rapid nucleic acid-based
identification of Candida or Aspergillus fungi species in biological
samples. This identification is accomplished by the targeting the
internally transcribed spacer-2 (ITS2) region that are unique to
various Candida species. The assay is sensitive, specific and rapid.
Implementation of the technology will facilitate earlier specific
diagnoses, and lead to better antifungal therapy implementation for
infected patients.
Potential Commercial Applications:
Directing antifungal drug therapy for improved patient
outcomes
Detection, discrimination of Candida and Aspergillus
species from biological samples
Addressing secondary infections of immunosuppressed
individuals
Competitive Advantages:
Easily adapted for use in kits
High-throughput capable
Rapid and cost-effective
Development Stage: In vitro data available
Inventors: Christine J. Morrison, Errol Reiss, Brian Holloway, Jong
Hee Shin (all of CDC)
Publication: Shin JH, et al. Rapid identification of up to three
Candida species in a single reaction tube by a 5' exonuclease assay
using fluorescent DNA probes. J Clin Microbiol. 1999 Jan;37(1):165-70.
[PMID 9854084]
Intellectual Property: HHS Reference No. E-339-2013/0--
PCT Application No. PCT/US1997/016423 filed 15 Sep 1997,
which published as WO 1998/011257 on 19 Mar 1998
US Patent No. 6,235,890 issued 22 May 2001
Various international issued patents
Related Technologies:
HHS Reference No. E-293-2013/0
HHS Reference No. E-332-2013/0
HHS Reference No. E-232-2013/0
HHS Reference No. E-335-2013/0
Licensing Contact: Whitney Blair, J.D. M.P.H.; 301-435-4937;
[email protected]
Nucleic Acid Assays for the Detection and Discrimination of Aspergillus
Fungi Species within Biological Samples
Description of Technology: This invention relates to assays for the
detection and species-specific identification of Aspergillus fungi.
Accurate clinical diagnosis of Aspergillus species has become
increasingly important as certain species, such as A. terreus and A.
fumigatus, are resistant to specific commonly employed antifungal
compounds. Most contemporary fungal diagnostic methods are time-
consuming and inaccurate. This invention directly addresses those
inadequacies by providing a method to rapidly and accurately
differentiate all medically important species of Aspergillus based on
differences in the DNA sequences of the internal transcribed spacer 1
region of ribosomal DNA.
Potential Commercial Applications:
Directing antifungal drug therapy for improved patient
outcomes
Detection, discrimination of Aspergillus species from
biological samples
Addressing secondary infections of immunosuppressed
individuals or asthmatics
Competitive Advantages:
[[Page 6599]]
Easily adapted for use in kits
Assay may be used in real-time PCR, in enzyme immunoassays
and/or in microarrays
High-throughput capable
Development Stage: In vitro data available
Inventors: Christine J. Morrison and Hans Peter Hinrikson (CDC)
Publications:
1. Hinrikson HP, et al. Assessment of ribosomal large-subunit D1-
D2, internal transcribed spacer 1, and internal transcribed spacer 2
regions as targets for molecular identification of medically important
Aspergillus species. J Clin Microbiol. 2005 May;43(5):2092-103. [PMID
15872227]
2. CDC Fact Sheet: Aspergillosis [http://www.cdc.gov/fungal/aspergillosis/]
Intellectual Property: HHS Reference No. E-335-2013/0--
PCT Application No. PCT/US2003/016076 filed 16 May 2003,
which published as WO 2003/097815 on 27 Nov 2003
US Patent No. 7,384,741 issued 10 Jun 2008
US Patent No. 7,871,779 issued 18 Jan 2011
Various international patents issued or pending
Related Technologies:
HHS Reference No. E-293-2013/0
HHS Reference No. E-332-2013/0
HHS Reference No. E-232-2013/0
Licensing Contact: Whitney Blair, J.D. M.P.H.; 301-435-4937;
[email protected]
Nucleic Acid-based Differentiation and Identification of Medically
Important Fungi
Description of Technology: This invention entails nucleic acid-
based assays for detecting the presence of pathogenic fungi such as
Histoplasma capsulatum, Blastomyces dermatitidis, Coccidioides immitis,
Pneumocystis brasiliensis, and/or Penicillium marneffei within a
sample. Within a healthcare setting, this particular approach can
greatly reduce pathogen identification time, better direct treatments
and ultimately improve patient outcomes. Further, this technology
provides improved diagnostic specificity compared to serologic tests
for circulating antibodies using patient serum samples- an approach
that may give particularly aberrant results for immunosuppressed
individuals, and who are frequently afflicted with opportunistic fungi.
This technology is readily adaptable as kits used for species-specific
identification of fungal pathogen infections and environmental
contamination.
Potential Commercial Applications:
Directing antifungal drug therapy for improved patient
outcomes
Detection, discrimination of fungal pathogens
Addressing secondary infections of immunosuppressed
individuals or asthmatics
Competitive Advantages:
Rapid, sensitive, simple and specific
Potential for automation and high-throughput screening
Easily adaptable to kit form
Development Stage: In vitro data available
Inventors: Mark D. Lindsley, Zhenyu Qin, Christine J. Morrison,
Jong S. Choi (all of CDC)
Publication: Lindsley MD, et al. Rapid identification of dimorphic
and yeast-like fungal pathogens using specific DNA probes. J Clin
Microbiol. 2001 Oct;39(10):3505-11. [PMID 11574564]
Intellectual Property: HHS Reference No. E-332-2013/0--
PCT Application No. PCT/US2002/030605 filed 25 Sep 2002,
which published as WO 2003/027329 on 03 Apr 2003
US Patent No. 7,427,472 issued 23 Sep 2008
Various international patents issued or pending
Related Technologies:
HHS Reference No. E-293-2013/0
HHS Reference No. E-232-2013/0
HHS Reference No. E-335-2013/0
Licensing Contact: Whitney Blair, J.D. M.P.H.; 301-435-4937;
[email protected]
Nucleic Acid Detection of the Fungal Pathogen Histoplasma capsulatum
from Clinical and Environmental Samples
Description of Technology: This invention relates to detecting
Histoplasma capsulatum by PCR using oligonucleotide probes specific for
the fungus. Histoplasmosis is a mycotic infection of varying severity,
usually localized in the lungs. Caused by H. capsulatum, infections are
usually symptomatic but can develop into chronic disease, especially in
immunocompromised individuals.
Test samples may originate from the environment (soil, for
example), where H. capsulatum spores are found or from clinical samples
obtained from patients. Furthermore, the invention also provides for
methods that detect the presence of H. capsulatum in a sample using a
nested, or two-stage, PCR assay.
Potential Commercial Applications:
Directing antifungal drug therapy for improved patient
outcomes
Occupational health and safety screening for workers who
may encounter bird or bat waste
Screening biological or soil samples for the presence of
fungal pathogens
Environment testing for immunocompromised patients
Competitive Advantages:
Rapid and precise
Cost-effective
Easily adapted for H. capsulatum detection kits
Can positively identify small sample sizes of as few as 10
spores
High-throughput capable
Development Stage: In vitro data available
Inventors: Millie Schafer and Thomas Reid (CDC)
Publications:
1. Reid TM, Schafer MP. Direct detection of Histoplasma capsulatum
in soil suspensions by two-stage PCR. Mol Cell Probes. 1999
Aug;13(4):269-73. [PMID 10441199]
2. CDC Fact Sheet: Histoplasmosis [http://www.cdc.gov/fungal/histoplasmosis/]
Intellectual Property: HHS Reference No. E-313-2013/0--US Patent
No. 6,469,156 issued 22 Oct 2002
Related Technologies:
HHS Reference No. E-293-2013/0
HHS Reference No. E-332-2013/0
HHS Reference No. E-232-2013/0
HHS Reference No. E-335-2013/0
Licensing Contact: Whitney Blair, J.D. M.P.H.; 301-435-4937;
[email protected]
Multiplexed Immunoassay for Rapid Serological Diagnosis of a Specific
Viral Infection in Clinical Samples
Description of Technology: CDC researchers have developed a
multiplexed diagnostic assay for sensitive detection and distinction
between viral group members based on the presence/absence of infection-
generated antibodies within a clinical serum sample. For example, this
assay can be used for rapid discrimination of a clinical unknown as
specifically a West Nile or St. Louis encephalitis viral infection.
This is particularly beneficial as these two viruses are typically
difficult to distinguish by standard serological assays.
This new technique uses microsphere/microbead-based flow-analysis
as a platform. Because of a basis in a pre-existing technology, the
technique can be easily incorporated into current state and health
department diagnostic testing protocols. The method is particularly
unique because the assay-generated data can be standardized and then
classified via discriminant analysis to determine the presence or
absence of antibodies of interest within the clinical sample tested.
[[Page 6600]]
Furthermore, along with allowances for single-result generation,
data manipulation and classification algorithms allow for assay output
comparisons to the original large data set references used in
development. In this way, results from different laboratories can now
be directly compared to one another, provided that the same controls
are used.
Potential Commercial Applications:
Clinical diagnostics for specific identification and
discrimination of viral infections
Research tool for evaluation of vaccine candidates
Assay standardization and quality control
Public health and viral outbreak surveillance programs
Competitive Advantages:
Increased efficiency compared to single-antibody
diagnostic approaches
Easily implemented and integrated into present protocols
and techniques, as this technology is based on current, widely used
flow-analysis platforms
Can be formatted as customizable kits for detection of
viral group antibodies
Rapid and precise
Ideal for high-throughput analyses
Development Stage: In vitro data available
Inventors: Alison J. Basile and Bradley J. Biggerstaff (CDC)
Publications:
1. Basile AJ, et al. Removal of species constraints in antibody
detection. Clin Vaccine Immunol. 2010 Jan;17(1):56-61. [PMID 19923570]
2. Basile AJ, et al. Multiplex microsphere immunoassays for the
detection of IgM and IgG to arboviral diseases. PLoS One. 2013 Sep
25;8(9):e75670. [PMID 24086608]
Intellectual Property: HHS Reference No. E-302-2013/0--
US Patent No. 7,933,721 issued 26 Apr 2011
US Patent No. 8,433,523 issued 30 Apr 2013
Various international patent applications pending or
issued
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4927;
[email protected]
Detection and Differentiation of Pathogenic Fungi in Clinical Samples
Using a Multi-Analyte Profiling System
Description of Technology: This invention provides a rapid,
sensitive and specific diagnostic tool for the detection of pathogenic
fungi and subsequent species-specific discrimination. CDC scientists
have developed nucleic acid probes to identify the six most medically
important Candida species and endemic mycoses, and to differentiate
them from other medically important fungi in a multi-analyte profiling
system. Candida fungi are one of the leading causes of clinically-
acquired bloodstream infections and, although improved antifungal
compounds have been recently introduced, they have unique, species-
specific treatment responses.
This multi-analyte approach has the potential to simultaneously
identify up to 100 different fungi in one assay. Additionally, the
assay is quite cost effective in terms of resource input, time invested
and technician labor. Used in conjunction with contemporary antifungal
medications, this assay provides a very rapid and specific diagnosis
allowing for the selective administration of appropriate compounds and
ultimately improved patient outcomes.
Potential Commercial Applications:
Directing antifungal drug therapy for improved patient
outcomes
Detection, discrimination of Candida species from
biological samples
High-throughput screening
Liquid or solid phase microarray development to detect
medically important fungi
Competitive Advantages:
Rapid, sensitive, simple and specific
Multi-analyte nature provides cost-efficiency
Easily adaptable to kit form
Permits the multiplexing of up to 100 different
hybridization reactions in a single sample
Development Stage:
Early-stage
In vitro data available
Inventors: Christine J. Morrison, Sanchita Das, Teresa Brown, Brian
F. Holloway (all of CDC)
Publication: Das, S. et al. DNA probes for the rapid identification
of medically important Candida species using a multianalyte profiling
system. FEMS Immunol Med Microbiol. 2006 Mar;46(2):244-50. [PMID
16487306]
Intellectual Property: HHS Reference No. E-293-2013/0--
PCT Application No. PCT/US2006/037640 filed 26 Sep 2006,
which published as WO 2007/038578 on 05 Apr 2007
US Patent No. 8,119,788 issued 21 Feb 2012
Several international filings issued or pending
Related Technologies:
HHS Reference No. E-232-2013/0
HHS Reference No. E-332-2013/0
HHS Reference No. E-335-2013/0
HHS Reference No. E-339-2013/0
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Novel Primate T-cell Lymphotropic Viruses (HTLV, STLV) for Development
of Diagnostics, Therapeutics, Research Tools, and Vaccines
Description of Technology: CDC researchers have isolated and
characterized the novel primate T-lymphotropic viruses denoted human T-
lymphotropic viruses 3 and 4 (HTLV-3 and HTLV4), that are believed to
have resulted from cross-species transmission at some point in the
past. It has been previously established that HTLV-1 causes adult T
cell leukemia and other inflammatory diseases; HTLV-2 is considered
less pathogenic than HTLV-1 and has been associated with a neurologic
disease similar to HTLV-1-associated myelopathy. At present, the human
pathologies of HTLV-3 and HTLV-4 are yet uncharacterized, but have been
identified as infecting rural Central African hunters who have much
greater risk of contact with non-human primates, sometimes infected
with simian T-lymphotropic viruses (STLVs). As HTLV infected
individuals from rural, isolated populations have increasing contact
with their urban brethren, there is increased potential for the rapid
spread of new viral zoonotic-originating pathogens, much like the
theorized ``bushmeat'' origins of HIV. There is a present and unmet
need for increased surveillance, study, and preventative therapeutics
directed towards mitigating the public health impact of these viruses.
This CDC developed technology provides methods and tools to that end.
Potential Commercial Applications:
Development of HTLV diagnostics
Simian/human T-cell lymphotropic virus research
Zoonosis surveillance
Vaccine design and development
Competitive Advantages:
Provides tremendous opportunity for phylogenetic, clinical
and epidemiological investigations of HTLV and STLV
Facilitates monitoring of viral diversity and study of
zoonotic disease transmission
Provides tools needed to address and mitigate a newly
emergent blood-borne disease before widespread, regional/global viral
dissemination occurs
Development Stage:
Early-stage
In vitro data available
Inventors: Donald S. Burke (Johns Hopkins Univ), Thomas M. Folks
(CDC), Walid Heneine (CDC), Eitel Mpoudi
[[Page 6601]]
Ngole (CDC), William M. Switzer (CDC), Nathan D. Wolfe (Johns Hopkins
Univ)
Publications:
1. Wolfe ND, et al. Emergence of unique primate T-lymphotropic
viruses among central African bushmeat hunters. Proc Natl Acad Sci U S
A. 2005 May 31;102(22):7994-9. [PMID 15911757]
2. Switzer WM, et al. Ancient, independent evolution and distinct
molecular features of the novel human T-lymphotropic virus type 4.
Retrovirology. 2009 Feb 2;6:9. [PMID 19187529]
Intellectual Property:
HHS Reference No. E-281-2013/0--
--PCT Application No. PCT/US2006/005869 filed 21 Feb 2006, which
published as WO 2006/091511 on 31 Aug 2006
--Various international patents granted and pending
HHS Reference No. E-281-2013/1--
--US Patent No. 7,794,998 issued 14 Sep 2010
--US Patent No. 8,541,221 issued 24 Sep 2013
Related Technologies: HHS Reference No. E-303-2013/2--
PCT Application No. PCT/US2008/064270 20 May 2008, which
published as WO 2008/144700 on 27 Nov 2008
U.S. Patent Application No. 12/600,995 filed 19 Nov 2009
U.S. Patent Application No. 14/013,947 filed 29 Aug 2013
Various international patents granted and pending
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Method for Finding Usable Portion of Sigmoid Curve (the Taylor Method),
Improved Assay Readouts, and Enhanced Quality Control/Assurance
Description of Technology: CDC researchers have developed
algorithmic methods for determining sigmoid curve optimums and
calculating component concentrations. Sigmoid curves are commonly
generated in bioassays and used to calculate results. Various
techniques have been used to define the curve, analyze the
observations, and calculate a concentration. This technology is an
algorithmic approach to identifying the usable portion of a sigmoid
curve. This approach is more objective than other methods, reducing the
variability introduced by individuals and/or by repetition and allows
substantially higher throughput in a situation where a lot of samples
are being analyzed using the same assay.
Potential Commercial Applications:
Observation and data analysis
Determining concentrations
Improving calculations and estimations
Enhancing consistency and reproducibility of outcomes for
bio and chem assays
Competitive Advantages:
Less output-data subjectivity than alternate methods
Rapid, accurate and simple to implement
Quality control and assurance for a number of assays such
as PCR, ELISA, toxin neutralization assays (TNA), flow cytometry, cell
death assays, titrations, etc.
Reduces data variability due to errant input
Easily adapted to high-throughput analyses
Demonstrated efficacy quantifying anthrax lethal toxin
neutralization activity
Development Stage: In vitro data available
Inventor: Thomas H. Taylor (CDC)
Publication: Li H, et al. Standardized, mathematical model-based
and validated in vitro analysis of anthrax lethal toxin neutralization.
J Immunol Methods. 2008 Apr 20;333(1-2):89-106. [PMID 18304568]
Intellectual Property: HHS Reference No. E-270-2013/0--
PCT Application No. PCT/US2004/008566 filed 19 Mar 2004,
which published as WO 2004/084708 on 07 Oct 2004
US Patent No. 7,469,186 issued 23 Dec 2008
Australia Patent No. 2004224317 issued 25 Feb 2010
Various international patent applications pending or
issued
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Real-time PCR and High Resolution Melt Analysis for Genotyping of
Chlamydophila psittaci
Description of Technology: This nucleic acid assay employs Light
Upon Extension (LUX) chemistry and High Resolution Melt (HRM) analysis
to detect and distinguish the different genotypes of Chlamydophila
psittaci. C. psittaci is an atypical pathogen which may result in
severe pneumonia upon infection of birds, mammals and humans (depending
on inter-relationships between host and pathogen genotypes). Presently,
C. psittaci clinical identification is achieved by a cumbersome and
time-intensive mix of ompA gene sequencing, microarray analysis, RFLP
and/or serological testing. Accurate and timely molecular C. psittaci
diagnosis techniques are not generally available in most clinical
facilities, leading to improper treatment of patients.
To that end, this robust CDC developed assay should be useful for
epidemiological studies and may provide valuable information for best
implementing public health measures in the event of outbreaks. This
tool may also offer greater insight into the heterogeneity and
dissemination of C. psittaci genotypes. Additionally, the assay can
serve as a veterinary diagnostic and/or pre-screening tool for
companion birds. Such applications would provide further benefit by
resulting in reduced transmission of the disease to humans.
Potential Commercial Applications:
Validation studies, proficiency testing
Public health and veterinary/zoonotic disease monitoring
programs
Diagnostic testing, especially within the poultry industry
Disease screening of companion birds
Competitive Advantages:
Rapid and simple
Simultaneous detection and discrimination of C. psittaci
genotypes
Improved efficiency in time and cost
Easily adapted for use in kits
Development Stage: In vitro data available
Inventors: Stephanie L. Mitchell and Jonas M. Winchell (CDC)
Publication: Mitchell SL, et al. Genotyping of Chlamydophila
psittaci by real-time PCR and high-resolution melt analysis. J Clin
Microbiol. 2009 Jan;47(1):175-81. [PMID 19005152]
Intellectual Property: HHS Reference No. E-266-2013/0-US Patent
Application No. 13/322,787 filed 28 Nov 2011
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Universal Diagnostic Assay for Detection and Identification of
Poxviruses in Clinical Samples
Description of Technology: CDC researchers have developed an assay
for detection and diagnosis of poxviruses within clinical samples or
from lab culture-systems. The assay specifically targets
chordopoxviruses (except avipoxviruses) for PCR-based identification;
an improvement upon the current standard of cell culturing
methodologies. Individual chordopoxvirus species can cause disease in
humans (e.g., vaccinia, cowpox, monkeypox/Molluscum contagiosum) and
animals (e.g., sheeppox, myxoma, swinepox, mule
[[Page 6602]]
deer pox, tanapox/Orf virus, Bovine popular stomatitis virus). Some
poxvirus species impart unique and obvious symptoms making them easy to
diagnose, while many others are clinically ambiguous. For instance,
parapoxvirus infections are often misdiagnosed as cutaneous anthrax,
which unnecessarily contributes to overuse of antibacterial agents.
There is therefore a demonstrated need to develop better diagnostic
tools to detect and properly identify the agent of poxvirus infections.
Regardless of the symptoms, this universal assay can quickly and
reliably detect chordopoxvirus presence in clinical samples, allowing
for proper identification, diagnosis, treatment, and improved patient
outcomes.
Potential Commercial Applications:
Nucleic acid-based diagnostic for `unknown rash' illnesses
and identifying novel poxviruses
Disease surveillance programs, including public health and
veterinary (livestock, domestic, wild/exotic)
Competitive Advantages:
Rapid and simple
Allows for high-throughput, simultaneous sample screening
Detects, identifies all low-G/C content non-avipox
chordopoxviruses and most known high-G/C content chordopoxviruses
Development Stage: In vitro data available
Inventors: Yu Li, Inger K. Damon, Hui Zhao (all of CDC)
Publication: Li Y, et al. GC content-based pan-pox universal PCR
assays for poxvirus detection. J Clin Microbiol. 2010 Jan;48(1):268-76.
[PMID 19906902]
Intellectual Property: HHS Reference No. E-265-2013/0--
PCT Application No. PCT/US2010/055061 filed 02 Nov 2010,
which published as WO 2011/056771 on 12 May 2011
US Patent Application No. 13/505,719 filed 02 May 2012
Various international patent applications pending
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Novel Rift Valley Fever Virus Vaccines
Description of Technology: This invention relates to recombinant
Rift Valley fever (RVF) viruses containing deletions in one or more
virulence genes. The recombinant RVF viruses, generated using a
plasmid-based reverse genetics system, can be used as vaccines to
prevent RVF infection in livestock and humans. The recombinant RVF
viruses grow to high titers, provide protective immunity following a
single injection, and allow for the differentiation between vaccinated
animals and animals infected with wild-type RVF virus. Additionally,
this technology relates to a method of using reverse genetics to
generate recombinant RVF viruses.
Potential Commercial Applications:
Rift Valley fever (RVF) virus vaccine development or
improvement
Prevention of RVF virus infection in livestock and humans
Biodefense, biosecurity
Competitive Advantages:
In vivo evidence shows single-dose protection
Allows for discrimination between vaccinated and
naturally-infected subjects
Useful for controlled screening of therapeutic compounds
Development Stage:
In vitro data available
In vivo data available (animal)
Inventors: Brian H. Bird, Cesar G. Albarino, Stuart T. Nichol,
Thomas G. Ksiazek (all of CDC)
Publications:
1. Bird BH, et al. Rift valley fever virus lacking the NSs and NSm
genes is highly attenuated, confers protective immunity from virulent
virus challenge, and allows for differential identification of infected
and vaccinated animals. J Virol. 2008 Mar;82(6):2681-91. [PMID
18199647]
2. CDC Fact Sheet: Rift Valley Fever [http://www.cdc.gov/vhf/rvf/]
Intellectual Property: HHS Reference No. E-254-2013/2--
PCT Application No. PCT/US2008/087023 filed 16 Dec 2008,
which published as WO 2009/082647 on 02 Jul 2009
US Patent Application No. 12/809,561 filed 18 Jun 2008
(select claims allowed as of 24 Oct 2013)
Additional applications granted and pending
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Personal Air Sampler for Collecting Airborne Aerosol Particulates for
Molecular Analysis
Description of Technology: This invention consists of a sampling
apparatus that utilizes one or more cyclone separators to collect
airborne particles from the atmosphere. The apparatus not only
separates out aerosols from the atmosphere, but also serves as a
collection tube for aerosol particles. Through its unique design, this
CDC-developed apparatus is able to use the centrifugal force of the air
flow on aerosolized particles forcing them to separate. Since the
sample is collected directly in a microcentrifuge tube, in situ
analysis of the ambient particulates can be performed. Analysis may
include, but is not limited to, PCR, immunoassay analysis, microscopic
spore counting, and counting colony-forming units. The device should
also have many additional uses for environmental surveillance and
occupational health applications.
Potential Commercial Applications:
Analysis of ambient air particulates
Environmental surveillance
Occupational safety monitoring
Biodefense
Long-term exposure assessment
Competitive Advantages:
Rapid, on-site sampling and analysis
Alternative to surface-sampling and culturing for
aerosolized biological agents
Superior extraction efficiency compared to filters,
impingers, and impactors
Real-world testing demonstrated device's ability to
collect airborne mold and mycotoxins, pollen and pollen fragments,
airborne dust particulates, as well as airborne influenza virus in a
hospital environment.
Development Stage:
In situ data available (on-site)
Prototype
Inventors: Teh-Hsun R. Chen, Gregory Feature, Jyoti Keswani,
Herbert D. Edgell (all of CDC)
Publications:
1. Lindsley WG, et al. A two-stage cyclone using microcentrifuge
tubes for personal bioaerosol sampling. J Environ Monit. 2006
Nov;8(11):1136-42. [PMID 17075620]
2. Blachere FM, et al. Bioaerosol sampling for the detection of
aerosolized influenza virus. Influenza Other Respir Viruses. 2007
May;1(3):113-20. [PMID 19453416]
3. Lindsley WG, et al. Measurements of airborne influenza virus in
aerosol particles from human coughs. PLoS One. 2010 Nov
30;5(11):e15100. [PMID 21152051]
4. Cao G, et al. Development of an improved methodology to detect
infectious airborne influenza virus using the NIOSH bioaerosol sampler.
J Environ Monit. 2011 Dec;13(12):3321-8. [PMID 21975583]
5. CDC-NIOSH Cyclone Bioaerosol Sampler Web page: http://www.cdc.gov/niosh/topics/aerosols/biosampler.html
Intellectual Property: HHS Reference No. E-244-2013/0--
US Patent No. 7,370,543 issued 13 May 2008
US Patent No. 8,205,511 issued 26 June 2012
[[Page 6603]]
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Warning System for Mobile Machinery Hazardous Zones
Description of Technology: This invention relates to a warning
system designed to protect individuals working near hazardous
machinery. The system consists of a proximity-warning transmitter
mounted to hazardous machinery and a receiver, worn by a worker,
capable of detecting the transmitter signal. This worker-safety system
can incorporate visual alerts and audible alerts. It also allows
automatic shutdown of machinery upon receiver activation and may be
particularly useful in the mining industry.
Potential Commercial Applications:
Auxiliary safety equipment for heavy machinery
Occupational health and safety
Mining worker safety
Competitive Advantages:
Easy transmitter installation
Signal can be adjusted for an audio or visual ``warning
zone alert'' and a proximal ``imminent danger zone alert''
Development Stage:
In situ data available (on-site)
Prototype
Inventors: William H. Schiffbauer and Carl W. Ganoe (CDC)
Publication: Schiffbauer WH. A workplace safety device for
operators of remote-controlled continuous mining machines. Am J Ind
Med. 1999 Sep;Suppl 1:69-71. [PMID 10519790]
Intellectual Property: HHS Reference No. E-239-2013/0--US Patent
No. 5,939,986 issued 17 Aug 1999
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Species-specific Nucleic Acid Detection Assay for Fungi
Description of Technology: This invention pertains to nucleic acid-
based assays for the detection of Aspergillus and other filamentous
fungi. Assays cover the species-specific detection and diagnosis of
infection by Aspergillus, Fusarium, Mucor, Penecillium, Rhizomucor,
Absidia, Cunninghamella, Pseudallescheria or Sporthrix in a subject.
This can reduce identification time from several days by conventional
culture methods to a matter of hours. Furthermore, genus-specific
probes are also provided for Aspergillus, Fusarium and Mucor, in
addition to an ``all-fungus'' nucleic acid probe. This technology is
readily adaptable as kits used for species-specific identification of
opportunistic pathogen infections or possible work/home contamination.
Potential Commercial Applications:
Directing antifungal drug therapy for improved patient
outcomes
Detection, discrimination of fungal species from
biological samples
Addressing secondary infections of immunosuppressed
individuals or asthmatics
Competitive Advantages:
Rapid, sensitive, simple and specific
Cost-efficiency compared to culture or sero-diagnostic
methods
Easily adaptable to kit form
High-throughput screening
Development Stage: In vitro data available
Inventors: Christine J. Morrison, Errol Reiss, Jong Soo Choi,
Liliana Aidorevich (all of CDC)
Intellectual Property: HHS Reference No. E-232-2013/0--
US Patent No. 6,372,430 issued 16 Apr 2002
US Patent No. 7,052,836 issued 30 May 2006
Related Technologies:
HHS Reference No. E-293-2013/0
HHS Reference No. E-332-2013/0
HHS Reference No. E-335-2013/0
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Improved Protein Quantification Process and Vaccine Quality Control
Production
Description of Technology: This CDC invention is a method for
identifying and quantifying a group of proteins in a complex mixture by
a liquid chromatography-tandem mass spectrometry assay. The technology
was developed for influenza although it can be used for a wide variety
of protein quantification applications. As specifically developed,
conserved peptides from the proteins of influenza (hemagglutinin,
neuramidase, matrix 1 and 2, and nucleoprotein) have been synthesized
and labeled to be used as internal standards for the quantification of
those proteins in a complex (biological or manufactured) matrix. One or
more of these peptides can be used to simultaneously detect and
quantify the target proteins by establishing mass ratios and
calibration curve comparison. This method for quantifying influenza
proteins and peptides in samples has potential for improving vaccine
production quality control and therefore, the effectiveness and overall
cost-efficiency of influenza vaccines.
Potential Commercial Applications:
Vaccine production, especially influenza-related
Quality assurance, quality control
Influenza surveillance programs
Competitive Advantages:
Simultaneous, precise protein detection and quantification
for complex mixtures
Rapid; method cuts investigation/research time needed to
formulate and optimize novel vaccines for emergent influenza strains
Improved vaccine cost and production efficiency
Development Stage:
Early-stage
In vitro data available
Inventors: Tracie L. Williams, John R. Barr, Zhu Guo, Leah G. Luna,
Ruben O. Donis, James L. Pirkle (all of CDC)
Publications:
1. Williams TL, et al. Quantification of influenza virus
hemagglutinins in complex mixtures using isotope dilution tandem mass
spectrometry. Vaccine. 2008 May 12;26(20):2510-20. [PMID 18440105]
2. Pierce CL, et al. Quantification of immunoreactive viral
influenza proteins by immunoaffinity capture and isotope-dilution
liquid chromatography-tandem mass spectrometry. Anal Chem. 2011 Jun
15;83(12):4729-37. [PMID 21591780]
3. Williams TL, et al. Simultaneous quantification of hemagglutinin
and neuraminidase of influenza virus using isotope dilution mass
spectrometry. Vaccine. 2012 Mar 23;30(14):2475-82. [PMID 22197963]
4. Woolfitt AR, et al. Amino acid analysis of peptides using
isobaric-tagged isotope dilution LC-MS/MS. Anal Chem. 2009 May
15;81(10):3979-85. [PMID 19364092]
Intellectual Property: HHS Reference No. E-212-2013/0--
PCT Application No. PCT/US2008/013396 filed 05 Dec 2008,
which published as WO 2009/110873 on 11 Sep 2009
US Patent No. 8,530,182 issued 10 Sep 2013
Licensing Contact: Whitney Blair, J.D. M.P.H.; 301-435-4937;
[email protected]
Novel Epitopes of Bacillus anthracis Lethal Factor for Development of
Diagnostics and Therapeutics
Description of Technology: CDC researchers have characterized
epitopes of Bacillus anthracis Lethal Factor (LF), a critical component
of the B. anthracis lethal toxin. These epitopes may allow for
development of therapeutics for the treatment or prevention of B.
anthracis infection. They may also allow screening for B. anthracis LF
in a sample and development of a peptide anthrax vaccine.
Potential Commercial Applications:
[[Page 6604]]
Diagnostic tests assessing active Lethal Factor in a
sample
Anthrax neutralizing therapeutics and vaccines for B.
anthracis
Biodefense, biosecurity
Competitive Advantages:
Potentially faster, lower-input assay compared to current
Edema Factor detection methods
Easily adaptable for high-throughput screening of numerous
specimens
Development Stage:
Early-stage
In vitro data available
Inventors: Jason Goldstein, Conrad Quinn, Dennis Bagarozzi, Anne
Boyer (all of CDC)
Publication: Boyer AE, et al. Detection and quantification of
anthrax lethal factor in serum by mass spectrometry. Anal Chem. 2007
Nov 15;79(22):8463-70. [PMID 17929949]
Intellectual Property: HHS Reference No. E-210-2013/0--
US Provisional Application No. 61/699,738 filed 11 Sep
2012
PCT Application No. PCT/US2013/059179 filed 11 Sep 2013
Related Technologies:
HHS Reference No. E-158-2013/2
HHS Reference No. E-167-2013/0
HHS Reference No. E-196-2013/0
HHS Reference No. E-203-2013/0
HHS Reference No. E-474-2013/0
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Respiratory Syncytial Virus Immunogens for Vaccine and Therapeutics
Development
Description of Technology: CDC researchers have developed specific
Respiratory Syncytial Virus (RSV) immunogens for use in the development
of RSV-directed vaccines and therapeutics. RSV is the most common cause
of serious respiratory disease in infants and young children and an
important cause of disease in the elderly. To date, efforts to make a
mutually safe and effective vaccine have been largely unsuccessful.
This invention addresses both problems.
CDC and collaborative researchers have demonstrated that a vaccine
based on amino acid sequences corresponding to group-specific regions
of the RSV G-protein can effectively induce antibodies, facilitate
virus clearance, decrease the virus-induced inflammatory response to
RSV challenge, and also decrease the enhanced disease following RSV
challenge. This composition may be used alone as a vaccine to safely
protect infants, children, and adults from RSV, as a booster with other
RSV proteins or with inactivated virus as a vaccine to ensure that it
can be given safely and effectively improve protection from RSV.
Potential Commercial Applications:
Prophylactic and therapeutic for the prevention and
treatment of RSV infections
Single or multi-component vaccine against RSV
Improvements to currently developed/developing vaccines
Developed antibodies may be employed for use in passive
immunity or RSV research
Competitive Advantages:
Increased safety, effectiveness compared to current
vaccines
Findings suggest likely prevention or mitigation of RSV-
related pulmonary disease for previously established infections
Development Stage:
In vitro data available
In vivo data available (animal)
Inventors: Larry J. Anderson (CDC), Lia M. Haynes (CDC), Ralph A.
Tripp (University of Georgia)
Publications:
1. Haynes LM, et al. Therapeutic monoclonal antibody treatment
targeting respiratory syncytial virus (RSV) G protein mediates viral
clearance and reduces the pathogenesis of RSV infection in BALB/c mice.
J Infect Dis. 2009 Aug 1;200(3):439-47. [PMID 19545210]
2. Miao C, et al. Treatment with respiratory syncytial virus G
glycoprotein monoclonal antibody or F(ab')2 components mediates reduced
pulmonary inflammation in mice. J Gen Virol. 2009 May;90(Pt 5):1119-23.
[PMID 19264600]
Intellectual Property:
HHS Reference No. E-197-2013/0--
--US Patent Application No. 13/763,822 filed 11 Feb 2013
HHS Reference No. E-197-2013/2--
--PCT Application No. PCT/US2010/044434 filed 04 Aug 2010, which
published as WO 2011/017442 on 10 Feb 2011
--Several international patent applications pending
Related Technologies:
HHS Reference No. E-699-2013/0
HHS Reference No. E-694-2013/0
HHS Reference No. E-151-2013/0
HHS Reference No. E-233-2013/0
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Controlled Expression and Assembly of Human Group-C Rotavirus-like
Particles for Creation of Rotavirus Diagnostic Assays and Improved
Vaccine Formulations
Description of Technology: CDC researchers have developed methods
of producing unlimited quantities of Group-C (GpC) rotavirus antigens.
GpC rotaviruses are a major, worldwide cause of acute gastroenteritis
in children and adults that is distinct from Group-A rotavirus.
However, GpC rotaviruses cannot be grown in culture, resulting in a
lack of tools for detection and treatment of GpC rotavirus disease.
Consequently, the true clinical burden of GpC rotavirus disease has not
been clearly established.
This technology allows for the expression of the three major capsid
proteins (VP2, VP6 and VP7) of GpC rotavirus by recombinant baculovirus
and assembly of virus-like particles (2-6-7 and/or 6-7) within insect
cells. Further, this CDC generated technology allows for the large-
scale access to GpC rotavirus antigens, previously infeasible, and will
permit use of these novel virus-like particles for the development of
rotavirus diagnostic assays and improved vaccine formulations.
Potential Commercial Applications:
Development or improvement of rotavirus vaccines
Rotavirus vaccine composition research
Childhood illness vaccination programs and rotavirus
monitoring endeavors
Development of novel rotavirus diagnostic tools
Competitive Advantages:
Permits large-scale production of Group-C rotavirus
antigens, previously impractical
Produced virus-like particles/antigens can be used for
rotavirus vaccines, other immunogenic uses and/or sero-diagnostic assay
development
Diagnostic tools for Group-C rotavirus are currently
unavailable; this technology fulfills an unmet need for accurate
assessment of the Group-C rotaviral global health burden
Development Stage: In vitro data available
Inventor: Baoming Jiang (CDC)
Publication: Clark KB, et al. Expression and characterization of
human group C rotavirus virus-like particles in insect cells. Virology.
2009 May 10;387(2):267-72. [PMID 19285329]
Intellectual Property: HHS Reference No. E-191-2013/2--
PCT Application No. PCT/US09/045688 filed 29 May 2009,
which
[[Page 6605]]
published as WO 2009/148964 on 10 Dec 2009
US Patent Application No. 12/995,024 filed 26 Jan 2011
Various international filings pending and/or deferred
Related Technologies:
HHS Reference No. E-122-2013/0
HHS Reference No. E-150-2013/0
HHS Reference No. E-153-2013/0
HHS Reference No. E-521-2013/0
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Diisocyanate Specific Monoclonal Antibodies for Occupational and
Environmental Monitoring of Polyurethane Production Exposure-related
Asthma and Allergy and Clinical Diagnosis
Description of Technology: CDC researchers have developed
monoclonal antibodies useful as diagnostics for diisocyanate (dNCO)
exposure and for toxicity characterization of specific dNCOs.
Currently, dNCOs are used in the production of all polyurethane
products and are the most commonly reported cause of occupational-
induced asthma and also linked to allergic contact dermatitis.
Presumptive diagnosis of dNCO asthma is presently dependent on criteria
such as work history, report of work-related asthma-like symptoms and
nonspecific airway reactivity to methacholine challenge.
This invention is a cost-effective, objective alternative for
clinical assessment of occupational/environmental dNCO exposure in
patient samples. These antibodies may also provide for passive-
immunization and prevention of allergic contact dermatitis and/or
asthma that can result from extended dermal exposure to dNCO
contaminated surfaces and vapors. Further, the present technology
allows for high-throughput testing of workplace dNCO air, fabric and
working-surface contamination.
Potential Commercial Applications:
Occupational/environmental safety biomonitoring of
polyurethane-worker/user exposure to diisocyanates(dNCOs)
Clinical diagnostic use
dNCO-induced allergy/asthma prevention by passive
immunization
Competitive Advantages:
Ready for use in high-throughput immuno-histochemistry
biomarker detection assays and kits
Two sandwich ELISAs have been developed and validated
using human samples
Monitoring is currently performed by elaborate analytical
chemical assays; this technology is more rapid and cost effective for
dNCO exposure/contamination assessment
Development Stage:
Early-stage
In vitro data available
Inventors: Paul D. Siegel, Donald H. Beezhold, Tinashe Blessing
Ruwona, Detlef Schmechel, Victor Johnson (all of CDC)
Publications:
1. Lemons AR, et al. Development of sandwich ELISAs for the
detection of aromatic diisocyanate adducts. J Immunol Methods. 2013 Nov
29;397(1-2):66-70. [PMID 24012971]
2. Ruwona TB, et al. Monoclonal antibodies against toluene
diisocyanate haptenated proteins from vapor-exposed mice. Hybridoma
(Larchmt). 2010 Jun;29(3):221-9. [PMID 20568997]
3. Ruwona TB, et al. Production, characterization and utility of a
panel of monoclonal antibodies for the detection of toluene
diisocyanate haptenated proteins. J Immunol Methods. 2011 Oct 28;373(1-
2):127-35. [PMID 21878336]
Intellectual Property: HHS Reference No. E-189-2013/0--US Patent
Application No. 12/577,241 filed 12 Oct 2009
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Real-time RT-PCR Assay for the Detection of Rift Valley Fever Virus in
Humans and Livestock
Description of Technology: A quantitative RT-PCR-based assay has
been developed to rapidly detect all known strains of Rift Valley fever
virus (RVFV). RVFV infections occur in both humans and livestock
animals resulting in significant mortality and economic loss. Upon
outbreak, RVFV has been known to cause devastating loss among livestock
(primarily sheep and cattle) with outbreaks characterized by sweeping
``abortion storms'' and elevation newborn animal mortality approaching
100% in affected areas. The CDC-developed assay is capable of detecting
and quantifying RVFV infection in both human and veterinary samples.
Potential Commercial Applications:
Diagnostic assay for the detection of Rift Valley fever
virus in human and veterinary samples
Research tool to quantitatively measure viral load in
laboratory specimens
Competitive Advantages:
Assay detects positive infections for 33 known variants of
Rift Valley fever virus
Easily adaptable to kits for high-throughput screening of
a large number of samples at once, useful for ensuring herd-health for
example
Development Stage: In vitro data available
Inventors: Brian H. Bird and Stuart T. Nichol (CDC)
Publications:
1. Bird BH, et al. Complete genome analysis of 33 ecologically and
biologically diverse Rift Valley fever virus strains reveals widespread
virus movement and low genetic diversity due to recent common ancestry.
J Virol. 2007 Mar;81(6):2805-16. [PMID 17192303]
2. Bird BH, et al. Multiple virus lineages sharing recent common
ancestry were associated with a Large Rift Valley fever outbreak among
livestock in Kenya during 2006-2007. J Virol. 2008 Nov;82(22):11152-66.
[PMID 18786992]
Intellectual Property: HHS Reference No. E-187-2013/0--Research
Tool. Patent protection is not being pursued for this technology.
Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937;
[email protected]
Entangling/Entrapping Synthetic Setae for Control of Insects and Other
Pests
Description of Technology: In nature, some beetle larvae possess
specialized barbed hastate setae that serve as an entanglement defense
mechanism and incapacitate other insects. CDC researchers have
developed synthetic setae for control and entrapment of insects and
other pests. While smaller synthetic setae can trap mosquitoes and
small insects, larger ``macro'' setae can be used for entrapment of
bats, rodents, etc. Once used, the setae can be ``reset'' by a vigorous
shaking of the fabric. This solution to pest control would be long-
lasting and non-toxic, with the additional benefit of avoiding the
evolutionary selection of pesticide resistant organisms.
Potential Commercial Applications:
Insect and pest control agents
Population sampling and monitoring
Competitive Advantages:
Fine entanglement setae can be used anywhere insects
congregate, including mosquito bed netting, resting boxes, curtains, or
wall linings
Mosquitoes and other pests trapped in the setae will
quickly desiccate
Easy reuse of setae by shaking
Long-lasting, non-toxic (no insecticide) alternative to
insect control
Development Stage: Prototype
Inventor: Robert Wirtz (CDC)
Intellectual Property: HHS Reference No. E-175-2013/0--US Patent
Application No. 61/772,790 filed 05 Mar 2013
Related Technologies: