Testing demand is such that just about the entire opponents providing multiplex panels are more likely to see adoption and development throughout flu season, Masucci stated. Lots of the corporations supplying multiplexed molecular diagnostic exams are more likely to “promote every part they’ll manufacture simply because the availability is so constrained,” he stated. “This precept will most likely carry over to the flu season as a result of the US remains to be not the place it must be when it comes to satisfying SARS-CoV-2 testing demand.”
Certainly, even smaller molecular diagnostic corporations, equivalent to GenMark Diagnostics, have “disproportionately benefited” from the rise in SARS-CoV-2 testing demand, he famous.
Based mostly in Carlsbad-California, GenMark has developed a check that integrates a SARS-CoV-2 viral goal with the agency’s FDA-cleared ePlex Respiratory Pathogen panel, which identifies 21 respiratory pathogens, together with SARS-CoV-2, flu A, and flu B.
The corporate obtained $749,000 from the US Division of Well being and Human Companies’ Biomedical Superior Analysis and Improvement Authority (BARDA) in March to develop the panel. It submitted the panel for FDA EUA in June and, in parallel, started distributing the product within the US for medical use.
Whereas totally different respiratory illnesses could current comparable signs in sufferers, their severity and the hazard they pose to sufferers can fluctuate extensively, underscoring the significance of extremely multiplexed exams, stated Scott O’Brien, GenMark Diagnostics’ senior vice chairman of world advertising and marketing and worldwide gross sales. “To diagnose sufferers, particularly these that may have indicators or signs of respiratory sickness, molecular assays will proceed to be the Cadillac of exams and the first alternative for clinicians.”
The agency stated lately that it’s growing capability for the upcoming flu season and expects to exit 2020 producing as much as 150,000 exams per 30 days. GenMark has three manufacturing strains and expects so as to add a fourth in the midst of the fourth quarter.
Meantime, Waltham, Massachusetts-based Thermo Fisher Scientific is growing multiplex panels that it believes will likely be prepared for the present respiratory seasons. A 3-target panel for the US market consists of exams for SARS-CoV-2, flu A, and flu B, and a second panel for the European market consists of targets for SARS-CoV-2, RSV, and flu A and flu B, however does not differentiate between the flu subtypes. The corporate anticipates making use of the identical manufacturing ramp-up approaches for the multiplex panels as for its present approved SARS-CoV-2 exams, stated Rachel Formosa. who leads Thermo Fisher’s advertising and marketing initiatives related to its COVID-19 and flu merchandise.
Multiplex testing is essential for labs as a result of it will possibly add efficiencies to workflows and scale back consumption of parts equivalent to swabs, stated Israel Figueroa, product supervisor for Thermo Fisher’s COVID-19 multiplex kits. “The choice choice is to run separate kits which can be particular for every situation, however that will increase testing complexity and consumption of parts.”
Qiagen’s Manissero stated that in previous flu seasons, fast flu antigen testing and single-plex PCR exams for influenza-like sickness have performed a screening function on the point-of-care, however within the coming flu season, “molecular testing and significantly PCR-based assays are probably to proceed driving testing.”
Late in March, Hilden, Germany-based Qiagen obtained FDA EUA for its QiaStat-Dx Respiratory SARS-CoV-2 Panel to be used in diagnosing sufferers contaminated with the coronavirus that causes COVID-19. The panel detects 22 viral and bacterial respiratory targets together with SARS-CoV-2, flu A, flu B, and RSV.
Austin, Texas-based Luminex has been advertising and marketing its NxTag CoV Prolonged Panel since March when it obtained FDA EUA, and laboratories are operating that check in parallel with the Luminex NxTag Respiratory Pathogen panel to concurrently detect 20 respiratory pathogens, together with a number of influenza subtypes.
The corporate stated lately that it expects to quickly acquire FDA EUA for added exams that it has developed and that it intends to market throughout the upcoming respiratory season. One is a consolidated respiratory panel that features a coronavirus goal known as the NxTag RPP plus SARS-CoV-2. The second is a standalone SARS-CoV-2 assay operating on the Verigene I instrument that may be run alongside the present Verigene respiratory pathogens flex-testing panel.
Luminex additionally plans to use for FDA EUA for a respiratory panel with a SARS-CoV-2 goal operating on its next-generation Verigene II molecular instrument. The Verigene II check is a totally automated, sample-to-answer system with 23 respiratory targets, together with influenza and SARS-CoV-2.
The “all-in-one” panels scale back the variety of samples, reducing affected person discomfort, and offering for sooner, extra complete testing whereas chopping down on the variety of required suppliers, Shapiro stated.
In July, Miller’s BioMérieux introduced that its all-in-one BioFire Respiratory Panel 2.1 plus, which exams for SARS-CoV-2 and different respiratory infections, obtained CE marking. The panel exams for 23 pathogens encompassing 19 viruses, together with SARS-CoV-2 and Center East Respiratory Syndrome coronavirus, and 4 micro organism that end in essentially the most frequent respiratory tract infections. An earlier model of the check obtained FDA EUA in Might.
The CDC, which was first to obtain EUA for a coronavirus check in February, additionally nabbed one for a molecular SARS-CoV-2-flu check in July.
Additional, Cepheid, a part of Washington, DC-based Danaher, has plans to launch a fast 4-in-1 check for detection of the coronavirus, flu A, flu B, and RSV from a single affected person pattern, and Roche introduced Friday that its Cobas SARS-CoV-2 & Influenza A/B check obtained FDA EUA. The multiplex check can be accessible in international locations accepting the CE mark
On Monday, three corporations introduced the event of multiplex respiratory panels. Laboratory Company of America stated it has developed a single-panel molecular check to detect COVID-19, influenza A/B, and RSV infections, accessible to sufferers within the US by way of docs, hospitals, and different approved healthcare suppliers. LabCorp has submitted an utility to the FDA to allow it to supply the mixed check by way of its Pixel by LabCorp at-home check assortment equipment, which makes use of a brief swab that’s inserted into the decrease nostril.
Additional, Seoul, South Korea-based Seegene stated it has launched a single tube real-time RT-PCR assay, the Allplex SARS-CoV-2/FluA/FluB/RSV check, that concurrently detects and differentiates flu A, flu B, RSV A/B, and three totally different goal genes of COVID-19 ─ the S gene, RdRP gene, and N gene.
Moreover, CerTest Biotec, primarily based in Zaragoza, Spain, introduced it has developed the Viasure SARS-CoV-2, Flu & RSV Actual-Time PCR detection equipment.