An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

In this section: Guidances (Drugs)

Reviews: Galactomannan

Detection of Galactomannan in Broncho-Alveolar Lavage Fluids
Galactomannan: Secondary (Biomarker Qualification) Statistical Review and Evaluation
Biomarker Qualification for Detection of Galactomannan in Serum and Bronchoalveolar Lavage Fluid by the Platelia Aspergillus Enzyme Immunoassay
Serum Galactomannan Platelia Assay for the diagnosis of Invasive Aspergillosis in Patients with hematologic malignancy or recipients of HSCT Clinical Review
Biomarker Qualification Microbiology Review Detection of Galactomannan in Serum by PlateliaTM Aspergillus Enzyme-linked Immunosorbent Assay (BioRad Laboratories and Sanofi Diagnostics)
Statistical Review and Evaluation Biomarker Qualification

Drug Development Tool (DDT): Biomarker Qualification Program

Top