The test is the second of three panels intended to detect pathogens that cause the bloodstream infections that can lead to sepsis.
In addition, Qiagen has partnered with Japan's SRL for companion diagnostic development, and its CareHPV test was added to the WHO list of prequalified IVDs.
The updated guidelines confirm HER2 gene amplification assessed by ISH and protein overexpression assessed by IHC are primary predictors of responsiveness to HER2 therapy.
Validation results presented at the Association for Molecular Pathology meeting demonstrate that the test can be implemented clinically, replacing existing FISH and PCR assays.
Performed on the company's Safetube platform, GFC's Microscreen test uses DNA hybridization to detect biomarkers in methicillin-resistant Staphylococcus aureus.