cytomegalovirus
Hologic Nabs FDA Approval for Quantitative Cytomegalovirus Test
The test runs on Hologic's Panther system and is intended to be used for post-transplant pathogen detection and monitoring.
FDA Proposes Reclassification of Cytomegalovirus Quantitative Tests
The proposed order is intended to give patients more timely access to the tests by moving them from Class III to Class II and providing special controls.
Roche BK Virus Test Garners FDA Clearance
The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.
DiaSorin Molecular Gets CE Mark for Congenital CMV Assay
The disease occurs when cytomegalovirus infection is passed from a mother to an unborn child and can lead to severe and potentially fatal outcomes.
Recent publications demonstrating the clinical utility of the CMV assay represent a step toward diversifying into different types of assays, the firm said.
Nov 9, 2018
Oxford Immunotec Q3 Revenues Grow 7 Percent
Jun 27, 2017
FDA Approves Abbott's Molecular CMV Assay
Apr 6, 2017