Qorvo’s Covid-19 test sounds good to the US FDA

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The Covid-19 pandemic has spurred healthcare innovation across the board, with the astonishing success of mRNA-based vaccines being perhaps the most obvious example. Sometimes, however, a new technology emerges that might cause industry watchers to wonder whether it was strictly necessary. The IT company Qorvo has obtained US emergency authorisation for a test for coronavirus antigens that uses sound waves. The sample is placed in a cartridge loaded into Qorvo’s Omnia benchtop analyser; if nucleocapsid antigens are present they bind to antibodies immobilised in the cartridge, forming a slightly heavier mass. The system then uses what Qorvo calls “bulk acoustic waves” to cause the molecules to resonate; the antibody-antigen complexes resonate at a different frequency from the unbound antibodies, allowing a sensor to detect whether Covid-19 antigens are present. Its accuracy is acceptable, but this technology has to be markedly more expensive than the much simpler lateral flow assays such as Abbott’s BinaxNow, which costs $5 per test. Still, Qorvo received the NIH’s backing in the form of a $24.4m contract to produce and launch the Omnia platform. It is nice to see innovation rewarded, but widespread uptake seems unlikely. 

Accuracy of selected FDA-authorised antigen tests
Company Test PPA NPA
Lumiradx  LumiraDx Sars-Cov-2 Ag test 97.6% 96.6%
Abbott Diagnostics  BinaxNow Covid-19 Ag card 97.1% 98.5%
Quidel  Sofia Sars antigen FIA 96.7% 100%
Quidel  Sofia 2 Flu + Sars antigen FIA 95.2% 100%
Qorvo Omnia Sars-Cov-2 Antigen Test 89.5% 100%
Access Bio CareStart Covid-19 antigen test 88.4% 100%
Becton, Dickinson and Company  BD Veritor system for Sars-Cov-2 84.0% 100%
PPA and NPA = positive and negative percent agreement. Source: FDA.

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