The partners will use the GeoMx Digital Spatial Profiler to identify new biomarkers in high-risk breast cancer and the nCounter to evaluate leukemia fusion testing.
The clearance marks the first time that the tests have been indicated to follow a new paradigm in which two enzyme immunoassay tests can be conducted concurrently or sequentially, the FDA said.
The company's diagnostics segment's revenues were up 6 percent, while its discovery and analytical solutions segment's revenues grew less than 1 percent.
The Singapore-based company will debut a system at AACC that performs real-time PCR flu A/B testing in less than 20 minutes for the cost of a lateral flow test.
The Branford, Connecticut-based startup plans to seek US Food and Drug Administration clearance for and launch its instrument and first assays in 2021.
