Assays for Measuring and Quantifying DNA Damage

Exposure to ionizing radiation or agents that induce DNA double-stranded breaks (DSBs), which is one of the most damaging types of lesions in DNA, can result in damage to cells and/or tissues.  Thiscan lead to illness (i.e., Acute Radiation Syndrome, Cancer) or death.  Identifying the amount of exposure to a DNA DSB-causing agent can be useful in determining the need for further testing, avoidance or modification of certain medical procedures, and/or types of medical treatments.

Methods for Selection of Cancer Patients and Predicting Efficacy of Combination Therapy

Available for licensing from the Laboratory of Cancer Biology and Genetics of the National Cancer Institute (NCI) is a novel gene signature of thirty-seven drug-responsive genes that links changes in gene expression to the clinically desirable outcome of improved overall survival. Expression of these genes has been linked to prognosis in several cancers, including, but not limited to: multiple myeloma, melanoma, and lung and breast cancers.

Henipavirus Vaccine

Henipaviruses are RNA viruses containing two high consequence human pathogens: Nipah virus (NiV) and Hendra virus (HeV). Both NiV and HeV infection in humans can result in severe respiratory disease and/or severe neurological manifestations, with mortality rates as high as 80%. There are currently no FDA-approved vaccines or therapeutics, and both NiV and HeV are considered dangerous emerging human pathogens with pandemic potential.

Monoclonal Antibodies to Fentanyl Analogs for Research, Therapeutics, and Novel Diagnostics

Fentanyl is a synthetic opioid drug approved by the Food and Drug Administration for use as an analgesic (pain relief) and anesthetic. However, synthetic opioids, such as fentanyl, are prone to abuse and are the primary drivers of overdose related deaths in the United States. As little as two milligrams of fentanyl can be lethal. Furthermore, structural variants of fentanyl, often mixed with other drugs or counterfeit pills are illegally distributed without the user’s knowledge.

Monoclonal Antibody that Detects a Subclass of Dog IgG—for Diagnostic and Research Applications

CDC and collaborating researchers have developed a new monoclonal antibody that recognizes canine IgG (likely IgG4 subclass). This anti-dog IgG reagent could be used to detect antibody reactions to a variety of antigens and has potential use in a wide variety of diagnostic or research applications.

Monoclonal Antibodies for Detection of Rabies Virus Antigen and Confirmatory Rabies Diagnosis

According to the World Health Organization (WHO), rabies causes greater than 59,000 deaths every year in over 150 countries as of 2017. A rapid and reliable diagnostic test for rabies is critical for prophylaxis considerations in humans bitten by animals as well as for basic surveillance and animal rabies control programs. The World Organization of Animal Health (OIE) and WHO Expert Committee on Rabies recently approved the direct rapid immunohistochemical test (DRIT) for rabies diagnostics.

Stable Human Cell Lines Expressing Flavivirus Virus-Like Particles (VLPs) for Vaccine, Biologics, and Diagnostic Development

Flaviviruses such as Zika virus, dengue virus, West Nile virus, yellow fever virus, and Japanese encephalitis virus cause widespread illness and death throughout the world. Typically, flaviviruses get transmitted through the bite of infected mosquitoes and ticks.

Nucleic Acid Amplification Technique for Rapid Diagnostic Analysis

CDC researchers developed a simple target-specific isothermal nucleic acid amplification technique, termed Genome Exponential Amplification Reaction (GEAR). The method employs a set of four primers (two inner and two outer). The outer primer pair targets three specific nucleic acid sequences at a constant 60°C, while the inner pair of primers accelerates and improves the sensitivity of the assay. The GEAR technique is an improvement over loop-mediated isothermal amplification (LAMP) in three ways.

Fluorescent Primer(s) Creation for Nucleic Acid Detection and Amplification

CDC researchers have developed technology that consists of a simple and inexpensive technique for creating fluorescent labeled primers for nucleic acid amplification. Fluorescent chemical-labeled probes and primers are extensively used in clinical and research laboratories for rapid, real-time detection and identification of microbes and genetic sequences. During nucleic acid amplification, the "UniFluor" primer is incorporated into newly synthesized double stranded DNA.
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