If approved, the kit would enable automated sample preparation for the company's T-SPOT.TB test using blood samples stored up to 54 hours at room temperature.
The submission data highlights Parsortix's ability to harvest circulating tumor cells from metastatic breast cancer patient blood samples for downstream analysis.
The submission follows a clinical validation study of the test that analyzed data from samples collected from 400 US and Canadian patients with advanced HR+ breast cancer.
The firm said that the shortage of testing in rural America highlights a need for its rapid molecular system, which is small enough to fit in a backpack.
The company said the nanowire technology it has been developing to detect traumatic brain injury also has the potential to enable rapid testing for SARS-CoV-2 at the point of care.
