The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
The firm is part of a research consortium that is led by Mount Sinai and includes Fluidigm to develop a device to detect epigenetic signatures of WMD exposure.
The company announced that it would begin offering seven proteomic tests at Colorado doctors' practices with up to four more to launch by the end of the year.
The company's goal is to serve what it sees as a massive but underaddressed target group: Asian women.
The FDA said its new pathway will address diagnostic devices for diseases that are less serious than those associated with its Breakthrough Devices Program.
The funding will be used in part for the ongoing commercialization of the company's EarlyCDT Lung test for lung cancer and the development of new tests.
The company said its APAS Independence platform can process 200 culture plates per hour and automatically remove nonsignificant plates from the workflow.
The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.