All currently marketed laboratory-developed tests, so-called traditional LDTs and tests for public health monitoring should be exempted from FDA oversight, except for reporting adverse events and malfunctions, according to a discussion paper released by the agency. "A prospective oversight framework that focuses on new and significantly modified high- and moderate-risk LDTs would best serve public health and advance laboratory medicine," the agency said.
An infant with a splenic injury and severe hemophilia A, a rare condition for newborns, was successfully treated with multiple blood transfusions and infusions of recombinant factor VIII concentrate without the need for surgical intervention, according to a case study in the journal Hematology Oncology and Stem Cell Therapy. After discharge, the infant "continued to be followed in our comprehensive hemophilia clinic every 6 months," the care team wrote.
Researchers at Emory University found that type A plasma can be used with minimal risk in a massive transfusion protocol for type AB or B trauma patients, though transfusion of more units may be needed. The 1,536-patient study, based on data from eight trauma centers, was presented at a meeting of the Eastern Association for the Surgery of Trauma.
Mesenchymal stem cell therapy led to the repair of damaged lungs in mouse models of chronic inflammatory lung disease, resulting in significant reduction in inflammation in lung tissues. The findings were presented at the Lung Science Conference of the European Respiratory Society.
Medecins Sans Frontieres and Medecins du Monde have filed a patent challenge with the European Patent Office against Gilead Sciences' Sovaldi, or sofosbuvir, treatment for hepatitis C, saying the drug's cost created a serious barrier to access.
Researchers with the University of California at Los Angeles have developed a test that uses a computer program to identify the type of cancer and its location based on data from a blood sample. "We built a database of epigenetic markers, specifically methylation patterns, which are common across many types of cancer and also specific to cancers originating from specific tissue, such as the lung or liver," professor Jasmine Zhou said.
Immortalized blood cell lines that produce red blood cells have been developed by scientists with the University of Bristol in collaboration with the Blood and Transplant division of the UK's National Health Service. The immortalized cells are stabilized at an early stage to create the Bristol Erythroid Line Adult, or BEL-A line, according to a report in the journal Nature Communications.
Monash University biospectroscopists from Australia are conducting an experimental trial to develop a new test that will detect the presence of malaria in the blood of villagers in impoverished, remote areas of Papua New Guinea. The kit consists of a portable spectrometer, a blood centrifuge, a laptop and a small battery and has the capacity to identify multiple malaria strains and identify asymptomatic carriers.
Novo Nordisk has received backing from the European Medicines Agency's Committee for Medicinal Products for Human Use for approval to market the hemophilia B drug Refixia, or nonacog beta pegol, in Europe. The opinion will be evaluated by the EMA.
European regulators have given HTG Molecular Diagnostics CE mark approval for its HTG EdgeSeq ALKPlus Assay EU, which is intended to facilitate mRNA ALK gene rearrangement measurement and analysis in lung tumor samples from patients who had a previous diagnosis of non-small cell lung cancer. The in vitro diagnostic assay, which operates on the company's EdgeSeq next-generation sequencing system, can help determine which patients may respond to ALK-targeted treatments.
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