gastrointestinal disease
Abbott, BioMérieux, Qiagen, Thermo Fisher Get 510(k) Clearances in May
The agency cleared new devices including syndromic panels for infectious diseases and digital pathology software as well updates to previously cleared tests.
Genetic Signatures Gets FDA 510(k) Clearance for GI Parasite Detection Kit
The Australian molecular diagnostics firm's PCR-based assay is used to identify infections with eight of the most common and clinically relevant GI parasites.
Genetic Signatures Halts Work on Molecular Respiratory Panel for US Market
The Australian infectious disease diagnostics firm said the US market for syndromic respiratory tests had become increasingly competitive while molecular testing had declined.
RCSI researchers have found a set of genes that are highly expressed in ulcerative colitis patients who progress to further stages of the disease that they hope to use in a diagnostic test.
Genetic Signatures Raises A$15.9M in Placement, Rights Offering
The infectious disease diagnostics firm plans to use the money to support regulatory clearances and commercialization of its PCR-based tests.