The microfluidic immunoassay uses spectrometry and a lateral flow method to diagnose the "very large global health problem" in about 20 minutes.
The test will be based on MRM Proteomics' immunoMALDI approach, which uses antibody enrichment of target proteins followed by analysis via MALDI mass spec.
The assays can be used to screen for and diagnose anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.
Aker Bio's test is used for determining whether a patient being treated with heparin may be developing heparin-induced thrombocytopenia.
Danish IVD firm BioPorto will distribute a version of its NGAL Test for use on the Cobas c 501/
The approval by WHO's Expert Review Panel for Diagnostics makes the test eligible for procurement by organizations that can access Global Fund and Unitaid resources.
The foundation will provide funding of no more than $20 million over the four-year term of the deal, and no more than $6 million each year.
The planned instrument will help provide spatial information on both protein and RNA in tumor samples and will be powered by nCounter technology.
The group this week published a set of initial guidelines for antibody validation meant as recommendations in advance of a larger meeting later this month.