The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
Hologic received clearance for a change to a probe reagent in the Aptima Combo 2 assay to detect variants of Chlamydia trachomatis that have emerged recently.
The diagnostics firm is conducting a 1,000-person study to find T cell profiles associated with the immune response to COVID-19 and recovery from the disease.
Tests that previously received FDA EUAs are either molecular, detecting viral nucleic acid, or serology tests that detect antibodies to the novel coronavirus.
Originally developed by Thermo Fisher Scientific, the test is modified for use on additional specimen types, including saliva, as well as with alternative nucleic acid extraction and amplification systems.
BioMérieux's BioFire received clearance for its Blood Culture Identification 2 Panel for the identification of nucleic acids associated with bacteria and yeast.
