Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company, today announces the launch of its Idylla™ SARS-CoV-2/Flu/RSV Panel (CE-IVD). Building upon the success of its Idylla™ SARS-CoV-2 Test (CE-IVD), the new Panel is launching as a CE-IVD and detects, in one single cartridge, SARS-CoV-2, Flu A/B and RSV(1) nucleic acids, with results in approx. 90 minutes.
The Idylla™ SARS-CoV-2/Flu/RSV Panel is a fully automated rRT-PCR(2) test intended for the qualitative detection of SARS-CoV-2, Flu A/B and RSV nucleic acids in nasopharyngeal swab specimens from individuals suspected of respiratory infections by their healthcare provider. The nasopharyngeal swab specimens are collected in a viral transport medium(3) and can be pipetted directly into the cartridge. The Idylla™ SARS-CoV-2/Flu/RSV Panel includes fully automated nucleic acid testing with the extraction, amplification and detection in a single-use cartridge, with less than 1 minute hands-on time.
The Panel showed excellent performance in the clinical performance study(4) with 98% overall concordance compared with other currently used methods.
Commenting on the launch of the Idylla™ SARS-CoV-2/Flu/RSV Panel, Herman Verrelst, Chief Executive Officer of Biocartis, said: “We take an important next step in strengthening our infectious disease menu by upgrading the Idylla™ SARS-CoV-2 Test(5) (CE-IVD) to a Panel that now also includes Flu A/B and RSV. Ahead of a delayed flu season, this Panel is well positioned to guide healthcare providers in this complex landscape of respiratory infections in 2022.”
The timing of the Emergency Use Authorization (‘EUA’) submission to the US FDA of the Idylla™ SARS-CoV-2/Flu/RSV Panel is still to be decided.
(1) Respiratory Syncytial Virus
(2) Real-Time Reverse Transcription-Polymerase Chain Reaction
(3) Of which 400 µl VTM is used in Idylla™
(4) Performance was evaluated across two arms of a clinical evaluation, all samples were residual nasopharyngeal swab in viral transport media. In the first arm 322 specimens were collected to evaluate the performance of the Idylla™ SARS-CoV-2/Flu/RSV Panel compared to the DiaSorin Molecular Simplexa™ Flu A/B & RSV Direct. In the second arm 341 specimens were collected to evaluate the performance of the Idylla™ SARS-CoV-2/Flu/RSV Panel compared to the Luminex Aries® SARS-COV-2 Assay. More information here
(5) The Idylla™ SARS-CoV-2 Test (CE-IVD) will remain available