Public genetic databases could have a discrepancy in identifying BRCA1 and BRCA2 variant classifications, which can introduce uncertainty and diminish patient care, according to a study by Myriad Genetics Inc. and researchers from Gradishar from the Feinberg School of Medicine at Northwestern University. The study was published in this month's edition of the journal The Oncologist and results from it show that the Clinvar public database provided discrepant variant classifications more than 26 percent of the time. The Salt Lake City-based company's study evaluated 4,250 BRCA1 and BRCA2 variants.
The FDA has issued an emergency use authorization (EUA) for Nanobiosym Diagnostics Inc.'s Gene-Radar Zika virus test. The Cambridge, Mass.-based company's diagnostic is authorized for the qualitative detection of RNA from Zika virus in human serum from individuals meeting Centers for Disease Control and Prevention (CDC) and/or epidemiological criteria by U.S. laboratories. Gene-Radar's EUA comes prior to the summer months where conditions are favorable for mosquitoes that can transmit the Zika virus. There are an estimated 4,800 people infected with Zika in the U.S., with an additional roughly 35,000 in the U.S. territories – primarily...
The FDA has issued an emergency use authorization (EUA) for Nanobiosym Diagnostics Inc.'s Gene-Radar Zika virus test. The Cambridge, Mass.-based company's diagnostic is authorized for the qualitative detection of RNA from Zika virus in human serum from individuals meeting Centers for Disease Control and Prevention (CDC) and/or epidemiological criteria by U.S. laboratories.
Alung Technologies Inc. has closed on its $36 million series C financing round that will go toward funding a pivotal trial for the private company's respiratory dialysis technology. The round was led by Royal Philips NV and UPMC, through its innovation and commercialization arm UPMC Enterprises. Other investors include Danvers, Mass.-based Abiomed, The Accelerator Fund, Allos Ventures, Birchmere Ventures, Blue Tree Ventures and Riverfront Ventures. Raymond James & Associates Inc. acted as lead placement agent for the transaction. The Pittsburgh-based company is seeking FDA approval for the Hemolung Respiratory Assist System (RAS), a minimally invasive...
Alung Technologies Inc. has closed on its $36 million series C financing round that will go toward funding a pivotal trial for the private company's respiratory dialysis technology. The round was led by Royal Philips NV and UPMC, through its innovation and commercialization arm UPMC Enterprises. Other investors include Danvers, Mass.-based Abiomed, The Accelerator Fund, Allos Ventures, Birchmere Ventures, Blue Tree Ventures and Riverfront Ventures. Raymond James & Associates Inc. acted as lead placement agent for the transaction.