The firm said that it expects to log $500 million in revenues from its Alere rapid diagnostics business in the second quarter.
Practice recommendations could serve as a guide for labs considering using the high-sensitivity assays as they become available, authors said.
The company will pay the US $33.2 million to settle allegations that it caused hospitals to submit false claims to federal healthcare programs.
The firm aims to have its test on the European clinical market by early next year, followed by a launch in the US.
The firm has licensed its test to Abbott, BioMérieux, and Quanterix, and it is working with the US Department of Defense as part of a collaborative approach.
Sensitivity problems with rapid antigen tests are also helping the more accurate rapid molecular tests gain wider acceptance, manufacturers said.
The test from Banyan Biomarkers called the Brain Trauma Indicator measures the levels of the proteins UCH-L1 and GFAP that are released into the blood.
Alere received FDA 510(k) clearances for four tests, including those for influenza A and B, strep A, and RNA-based respiratory syncytial virus.
Angle aims to show that clinicians can determine HER-2 status by subjecting harvested circulating tumor cells to fluorescence in situ hybridization (FISH).