The decision, which enables Medicare reimbursement, is effective for tests administered on or after Dec. 1.
BioDirection is collaborating with CENTER-TBI, an EU initiative that aims to advance the care of patients with traumatic brain injury.
The researchers said the test performed well in distinguishing patients with or without complications and proved itself better than frequently used clinical variables.
Erada Technology Alliance said the Global Health Innovative Technology Fund grant facilitates production, testing, and validation trials for the rapid test for malaria.
The firm said it anticipates launching the platform in Europe next year and completing its first round of external financing in the first quarter of 2020.
Unlike existing methods for sepsis diagnosis, which rely on the use of a single marker, Mologic's technology is based on six undisclosed markers.
The firm said that investigators will evaluate the clinical benefit of its assay using blood samples from a clinical trial for women with metastatic hormone receptor-positive breast cancer.
The firm anticipates that point-of-care adoption may attract licensing deals from companies interested in adding the biomarkers to their large laboratory analyzers.
The German firm said that IB10 Sphingotec DPP3 is the first CE-IVD-marked point-of-care biomarker test that can quantify DPP3 blood plasma levels.
The firm said that its lateral flow test may enable sports teams and paramedics to quickly decide whether there's a concussion or not.