The Rehovot, Israel-based firm expects to soon receive marketing clearance from the US Food and Drug Administration for its methylation-based Bladder EpiCheck test.
While the human toll of the disease has been terrible, IVD makers also report there have been some positive developments, as demand has spiked and familiarity with testing has grown.
Diagenode already sells more than 30 real-time PCR tests that are CE-marked for the detection of bacteria, parasites, and viruses for multiple infectious diseases.
Compared with RT-PCR testing, Abbott's BinaxNow test had a sensitivity of 64 percent for samples from symptomatic people and nearly 36 percent for asymptomatic people.
