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.

Non-invasive diagnostic and prognostic assay for early stage lung cancer

In the United States alone, one of four cancer deaths occur from lung cancer and there are over 8 million individuals considered to be at high-risk due to cigarette smoking and other behaviors. It's well known that early detection of cancer significantly improves survival of this disease, however a lack of lung cancer screenings and analysis precludes fast results at a low cost.

Detection of Hepatitis C Virus for point of care kit

Hepatitis C virus (HCV) is a major global health problem with an estimated 58 million infections in 2019.  However, most HCV infections go undiagnosed due to the lack of clinical symptoms or for lack of access to simple and affordable diagnostic testing. It is estimated that only 21% and 61% of people with a chronic HCV infection have been diagnosed, worldwide and in the United States, respectively.

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.

Novel One-Well Limiting-Antigen Avidity Enzyme Immunoassay to Detect Recent HIV-1 Infection Using a Multi-subtype Recombinant Protein

This CDC developed Limiting-Antigen avidity Enzyme Immunoassay (LAg-avidity-EIA) provides an easy way to measure increasing binding strength (avidity) of HIV antibodies as part of maturation HIV antibodies after seroconversion, providing a method to distinguish early-stage from long-term HIV-1 infection. Surveillance of HIV-1 provides information on prevalence rates of the disease, but determination of new infection rates (HIV-1 incidence) is difficult to deduce. Longitudinal follow up is expensive and can be biased.

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.