Status on Qlife’s COVID-19 tests
Qlife announced on 22 April that a research agreement had been made with Nordsjällands Hospital (NOH), for continued validation of the COVID-19 test. The validation at NOH was initiated immediately when the agreement was made and is still ongoing. Qlife is validating simultaneously with another research institute, and has been able to bring the validation forward at the anticipated pace. The validation of the SIBA technology is mainly performed on a multi-sample device (working name Big Egoo), as it allows analysis of more data simultaneously, and brings the data collection forward at a faster pace. At the same time, it validates the SIBA technology for COVID-19 screening on a larger scale, which gives Qlife the opportunity to offer larger testing volumes – a general market request at the current time. The outcome of the validation so far is very satisfactory, with sensitivity and specificity on par with PCR. We are extremely happy with these interim results, and it confirms our strong belief in our products as a high quality, reliable and efficient solution for the present and for future need. Further, Qlife announced that a sales contract was made on 12[th] May with KMD and Divisionsforeningen, to deliver test capacity as from week 22. Since validation of the SIBA technology on a Big Egoo device is already ongoing, Qlife is able to deliver – already from last week – the test capacity that this contract requires. The Big Egoo is as device not a commercial product or priority at this stage for Qlife but is a complement that enables Qlife to offer larger scale testing for specific events and acute situations. The tests Qlife are delivering until the product is CE marked, are screening tests under a RUO (Research Use Only) label. Over the coming weeks Qlife will be focused on delivering test capacity to KMD and Divisionsforeningen, continued data collection and validation in the Big Egoo and the Egoo Home system. We expect that the data collection for a CE mark will continue over the coming two-four months. The SIBA Technology “SIBA” refers to Strand Invasion Based Amplification and is an isothermal amplification technology for amplifying a nucleic acid target molecule. Isothermal amplification offers significant advantages over polymerase chain reaction (PCR) in that it does not require thermal cycling or sophisticated laboratory equipment. SIBA technology is resistant to non-specific amplification, it can detect a single molecule of target analyte and does not require target-specific probes. The technology relies on the recombinase-dependent insertion of an invasion oligonucleotide into the double-stranded target nucleic acid. SIBA is consequently highly specific and able to distinguish closely related species with even single nucleotide specificity in the absence of complex probes or sophisticated laboratory equipment.