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Available Technologies for Licensing and Collaboration

Gastrointestinal Diseases

Rotavirus

Respiratory Diseases

Anthrax (caused by Bacillus anthracis)

General/Multi-purpose Respiratory

Influenza

Pneumonia

Respiratory Syncytial Virus (RSV)

Tuberculosis

Sexually Transmitted Diseases

HIV

Simian HIV (SHIV)

Tropical, Emerging, & Zoonotic Diseases

Crimean-Congo

Dengue-Specific

Ebola

Flavivirus (including Dengue)

Heartland Virus

Lyme

Rabies

Rift Valley Fever

Other Infectious Diseases

The image shows an assay to characterize influenza viruses. CDC PHIL photo, Todd Jordan.

CDC PHIL photo, Todd Jordan.

Antibiotic/Antimicrobial Resistance

Fungal/Fungi Detection

Gastrointestinal

Hepatitis

Rabies and Lyssaviruses

Respiratory

Sexually Transmitted Diseases

HIV (Subtypes 1 & 2) and Simian HIV

Tropical Diseases/Flaviruses

Other

Featured CDC Technology

photo depicts and Aedes species mosquito

Photo credit James Gathany, CDC

CDC Trioplex Real-Time RT-PCR Assay for Detection and Differentiation of Zika,
Dengue, & Chikungunya Virus Infections in One Clinical Sample

  • CDC researchers developed a diagnostic assay for the detection and
    differentiation of Zika, chikungunya and dengue viruses
  • Currently, there is no multiplex PCR assay on the market that can detect and differentiate Zika, dengue and chikungunya in one test
  • There is no FDA-approved chikungunya test on the market and current Zika and dengue tests must be run separately

Previously Featured CDC Technology

photo depicts an Aedes species mosquito

Photo depicts an Aedes species mosquito

CDC Mosquito Trap for Control and Surveillance of Aedes Mosquitoes Including
Carriers of Zika, Dengue, Yellow Fever, Chikungunya and Other Viruses

  • CDC researchers developed the autocidal gravid ovitrap (AGO) device that targets older female mosquitoes looking for a place to lay eggs
  • CDC and the Puerto Rico Department of Health are implementing large-scale installation of AGO traps throughout several communities to reduce mosquito populations and the viruses they spread after successful field trials
  • Traps can be used for surveillance and control of Aedes aegypti and Ae. albopictus mosquitoes

Assay for the Detection of Factor-Neutralizing IgG Antibodies in Congenital and Acquired Hemophilia Patients

Hemophilia is an inherited bleeding disorder caused by genetic mutations resulting in deficiencies in coagulation factors necessary for blood clotting. The two forms of hemophilia, hemophilia A and hemophilia B, collectively affect an estimated 400,000 people worldwide. In addition, about 1-in-1,000,000 people who do not have hemophilia A or B will develop factor inhibitors, leading to acquired hemophilia. The primary form of treatment for any hemophilia is infusion therapy to replace the missing or dysfunctional coagulation factor. A subset of patients develop an immune response to the infusion product, which leads to the production of neutralizing antibodies called inhibitors. Inhibitors bind to and inhibit the function of infused factor, which nullifies any treatment benefit, including the restoration of clot formation. Development of inhibitors makes it more difficult to stop a bleeding episode and markedly increases hospitalizations, patient morbidity, and cost of treatment. Early identification of patients who develop inhibitors is crucial for optimizing patient management strategies.

CDC scientists have developed a fluorescence immunoassay (FLI) to directly detect immunoglobulin G (IgG) subclasses of inhibitors in patient samples. The FLI method offers greater sensitivity than currently available methods and requires significantly smaller (approximately 50 times less) patient plasma volumes for detection. Additionally, the FLI method is not affected by the presence of bypassing agents used in hemophilia treatment or by non-specific inhibitors of coagulation; it is more amenable to uniform inter-laboratory positive thresholds, and since it is IgG subclass-specific, it is capable of identifying antibodies known to cause clinically relevant inhibition.

Potential Commercial Applications
  • Diagnostic test kit for local clinical laboratories and hemophilia treatment centers
    • Latex immuno-agglutination and luminescent oxygen channeling assays to run on automated coagulation analyzers
    • Enzyme-linked immunosorbent assay
  • Pre-screening for congenital and acquired hemophilia patients prior to factor therapy administration
  • Detection of specific antibodies in acquired hemophilia
  • Distinguishing factor inhibitors from lupus anticoagulants
  • Inhibitor surveillance programs
  • Research tool to perform quality assurance/quality control on the inhibitor detection methods that are currently used in clinical laboratories and/or to serve as a confirmatory test for specimens that have results approaching positive thresholds using current methodologies
Competitive Advantages
  • High sensitivity and specificity
  • Direct detection of coagulation factor inhibitors with IgG subclass specificity
  • Easy to interpret results
  • Smaller sample volume inputs required
  • More amenable to uniform inter-laboratory positive thresholds
  • Fewer false positives or false negatives versus currently available methods
  • Assay not affected by bypassing agents or next generation factor treatment products with extended half-lives
 

Intellectual Property
HHS Reference No. E-083-2018/0.

Inventors: Brian Boylan (CDC) and Connie Miller (CDC)

Market without protection.

CDC Reference No. I-004-18.

*Contact CDC TTO at 404.639.1330 or TTO@cdc.gov for more information.

Laboratory Diagnostic Additive Treatment for Clotted Blood Specimens – Blood-Sera Recovery
Additive (B-SeRA)

Blood samples arriving in clinical, forensic, emergency response and research laboratories for testing are often rejected due to clotting. This decreases the reactive capabilities of medical, law enforcement, and public health responses. To recover testable material, the clotted blood specimens usually require manual filtration, which often yields only 10% of the initial sample volume. Additionally, harsh acid treatments are used which can affect the ability to find certain components [of blood/serum] such as biomarkers. These treatment processes are labor-intensive and time-consuming, leading to an increase in processing costs and delaying test results.

B-Sera CDC scientists have developed a simple method and additive for test kits to treat clotted blood specimens. As a novel alternative to manual filtration, the Blood-Sera Recovery Additive (B-SeRA) yields over 80% of the initial sample volume and accelerates laboratory processing time by at least six hours per specimen. This salvageable gain in biomarkers yields more material for multiple analyses and improves diagnostic sensitivity. Since the B-SeRA has no observed effect on the diagnostic specimen or test, it complies with FDA guidelines. This discovery is a critical tool in clinical, forensic, and public health response, especially during emergency situations when sample collection and storage can be suboptimal. The B-SeRA can also help avoid costly redraws, reduce patient treatment hours, and avoid reanalyzing the specimen.

Potential Commercial Applications

  • Laboratory diagnostic additive treatment for clinical, forensic, research, and clinical trial specimen testing
  • Opportunity to package as “blood processing tubes, packets, or test plates” which can increase fluid recovery by 400% as compared to conventional blood clot processing
  • Low-cost additive for processes and/or test kits to remedy clotted blood specimens
  • Monitoring, surveillance, and public health response preparedness – supplement to process any ex-vivo clinical blood specimens during outbreak or non-outbreak testing

Competitive Advantages

  • Simple and effective treatment for clotted blood specimens
  • No other known products on the market to treat clotted blood samples
  • Can be used in standard processing or added to a test kit
  • Has minimal to no effect on diagnostic biomarkers and adheres to FDA guidelines
  • Reduces sample preparation time by at least 6 hours and also decreases processing costs per specimen
  • Helps to avoid costly redraws, increased patient treatment hours, and reanalyzing the specimen
  • Can facilitate saving valuable data points in clinical trial testing

HHS Reference No. E-140-2018-0

Inventors: Melissa Carter (CDC), Samantha Isenberg (CDC), Aimee Sanford (CDC) and Rudolph Johnson (CDC)

CDC Reference No. I-007-18

*Contact CDC TTO at 404.639.1330 or TTO@cdc.gov for more information.

  • Page last reviewed: October 11, 2017
  • Page last updated: April 5, 2016
  • Content source:
    • Office of the Associate Director for Science
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