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real-time PCR

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.

The firm's quarterly revenues beat estimates. Its full year revenues also beat estimates and were up 10 percent year over year.

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.

The Maverick instrument enables calibration-free multiplex testing in the field and is supported by cloud-based software.

The organization intends to deploy a prototype of the platform in Brussels Airport next summer.

The PCR test is the first offering from the firm, formerly known as Concepta, since it acquired Manchester-based startup The Genome Store in November.

Called the COVID Bubble Test, the UK-based service allows the testing of up to 10 people on a single cartridge for £100, or £10 per person.

The assay can be used to pool up to five specimens collected from individuals suspected of having COVID-19 or from asymptomatic patients.

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