This technology describes the use of novel mutated anthrax protective antigen (PA) protein variants to target tumor cells and tumor vasculature. NIH scientists have engineered two PA variants that selectively complement one another and combine to form active octamers that target tumor cells. This controlled oligomeric activation of the PA proteins makes the likelihood of toxicity to non-tumor cells very low since non-tumor tissue does not express certain cell-surface proteases required to activate the PA variants.

Due to the disorganized nature of blood vessels that run through tumors, chemotherapeutic agents often fail to penetrate tumors and kill cancer cells at the tumor’s center. This can lead to ineffective chemotherapeutic treatments, because tumors can quickly grow back if the entire tumor is not destroyed. NIH researchers have developed a therapeutic agent that solves this problem facing current chemotherapy treatments.

This technology relates to a method of generating artificial compositions that can be used as positive controls in a genetic testing assay, such as a diagnostic assay for a particular genetic disease. Such controls can be used to confirm the presence or absence of a particular genetic mutation. The lack of easily accessible, validated mutant controls has proven to be a major obstacle to the advancement of clinical molecular genetic testing, validation, quality control (QC), quality assurance (QA), and required proficiency testing.

Our technology describes unique genetic signatures in patients with digestive diseases and liver disorders. Using comprehensive analysis of 735 microRNAs and 19,000 mRNAs, we have identified a unique set of microRNAs and/or mRNAs which predict disease phenotypes in patients with digestive and liver disorders. The identification of such point-of- care genetic signatures is significant for both personalized biomarkers and novel targeted biotherapeutics. These microRNAs and mRNAs function either together or separately thus modulating protein expressions in one or more signaling pathways.

Vaccines and therapies to prevent and treat Norovirus infections do not exist, despite the worldwide prevalence of Norovirus infections. Outbreaks of human gastroenteritis attributable to Norovirus commonly occur in group setting, such as hospitals, nursing homes, schools, dormitories, cruise ships and military barracks.

The present invention provides a therapeutic method for the treatment of autoimmune or autoinflammatory diseases by first breaking down the dysregulated immune system and then reprogramming the immune system to restore tolerance to the patient's self-antigens by induction of antigen specific regulatory T cells. The inventors have shown that only with the combination of apoptosis, phagocytes, and antigen can antigen-specific regulatory T cells (T_reg) cells be optimally generated to develop long-term immune tolerance.

This CDC invention relates to primers and probes that specifically hybridize with Heartland virus (HRTLDV), a unique member of the genus Phlebovirus. It further relates to polyclonal antibodies specific for HRTLDV proteins. Serological detection assays using HRTLDV nucleic acid molecules, proteins, probes, primers, and antibodies are provided. Importantly, the HRTLDV genome can be engineered using reverse genetics to be attenuated, allowing development of a vaccine for other viruses within the Phlebovirus genus or Bunyaviridae family.

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.

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.