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FDA clearance

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.

Clinicians will be able to use the assay to help identify patients with metastatic NSCLC for treatment with nivolumab and ipilimumab. 

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.

The Euroimmun's Anti-SARS-CoV-2 ELISA test is the first serology test whose results were independently validated by the federal government.

The firm said the FDA clearance was supported by data across several lab sites and all variant classes in clinical samples from 35 tumor types.

Thermo Fisher's line of ImmunoCAP assays are designed to detect immunoglobulin E in order to identify allergic sensitization to a range of allergens.

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.

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