Northeastern University
FDA Grants Emergency Use Authorization for Northeastern University SARS-CoV-2 Test
The RT-PCR-based test was developed by Northeastern University's Life Sciences Testing Center.
The firm is starting a trial that it anticipates will lead to an application for marketing clearance with the US Food and Drug Administration by next year.
The company believes it can provide tests to predict patients' responsiveness to specific drugs akin to the molecular diagnostics that have now swelled the oncology space.
The researchers have prospectively validated a disposable cartridge-based microfluidic assay by obtaining results using fine-needle aspirates in 40 patients.