Companion Diagnostics: State of the Art and New Regulations.

Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.

Organ donation in the US and Europe: The supply vs demand imbalance.

Organ donation and transplantation remain the best and most cost-effective clinical solution for end-stage organ failure. Several agencies across the US and Europe provide legislative, regulatory, and humanitarian services to generate smoother applications in all transplantation processes and donor-recipient relationships. US and European statistics present nine types of grafts, with kidneys being the most transplanted organ worldwide.

Impact of Design on Medical Device Safety.

The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre- and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.

MobiSeq: De novo SNP discovery in model and non-model species through sequencing the flanking region of transposable elements.

In recent years, the availability of reduced representation library (RRL) methods has catalysed an expansion of genome-scale studies to characterize both model and non-model organisms. Most of these methods rely on the use of restriction enzymes to obtain DNA sequences at a genome-wide level. These approaches have been widely used to sequence thousands of markers across individuals for many organisms at a reasonable cost, revolutionizing the field of population genomics.

Persistence of low-pathogenic H5N7 and H7N1 avian influenza subtypes in filtered natural waters.

Wild aquatic birds are the natural reservoir of avian influenza virus (AIV), and the virus is transmitted among birds through a fecal-oral route. Infected birds excrete significant amounts of AIV into the environment, and thereby sustain the circulation of AIV in the bird populations. Improved knowledge on the influence of environmental factors on the persistence of AIV in natural habitats would be valuable for risk assessments.

Persistence of low-pathogenic avian influenza H5N7 and H7N1 subtypes in house flies (Diptera: Muscidae).

Avian influenza caused by avian influenza virus (AIV) has a negative impact on poultry production. Low-pathogenic AIV (LPAIV) is naturally present in wild birds, and the introduction of the virus into domestic poultry is assumed to occur through contact with wild birds and by human activity, including the movement of live and dead poultry, and fomites such as clothing and vehicles. At present, the possible role of insects in the spread of AIV is dubious.

Activation of the brain-specific neurogranin gene in murine T-cell lymphomas by proviral insertional mutagenesis.

Neurogranin (Nrgn) is a highly expressed brain-specific protein, which sequesters calmodulin at low Ca(2+)-levels. We report here on retroviral activation of the Nrgn gene in tumors induced by the T-cell lymphomagenic SL3-3 murine leukemia virus. We have performed a systematic expression analysis of Nrgn in various mouse tissues and SL3-3 induced T-cell tumors.

Analysis of wild-type and mutant SL3-3 murine leukemia virus insertions in the c-myc promoter during lymphomagenesis reveals target site hot spots, virus-dependent patterns, and frequent error-prone gap repair.

The murine leukemia retrovirus SL3-3 induces lymphomas in the T-cell compartment of the hematopoetic system when it is injected into newborn mice of susceptible strains. Previously, our laboratory reported on a deletion mutant of SL3-3 that induces T-cell tumors faster than the wild-type virus (S. Ethelberg, A.