Testing demand is such that almost all of the competitors offering multiplex panels are likely to see adoption and growth during flu season, Masucci said. Many of the companies supplying multiplexed molecular diagnostic tests are likely to “sell everything they can manufacture just because the supply is so constrained,” he said. “This principle will probably carry over to the flu season because the US is still not where it needs to be in terms of satisfying SARS-CoV-2 testing demand.”
Indeed, even smaller molecular diagnostic companies, such as GenMark Diagnostics, have “disproportionately benefited” from the increase in SARS-CoV-2 testing demand, he noted.
Based in Carlsbad-California, GenMark has developed a test that integrates a SARS-CoV-2 viral target with the firm’s FDA-cleared ePlex Respiratory Pathogen panel, which identifies 21 respiratory pathogens, including SARS-CoV-2, flu A, and flu B.
The company received $749,000 from the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) in March to develop the panel. It submitted the panel for FDA EUA in June and, in parallel, began distributing the product in the US for clinical use.
While different respiratory ailments may present similar symptoms in patients, their severity and the danger they pose to patients can vary widely, underscoring the importance of highly multiplexed tests, said Scott O’Brien, GenMark Diagnostics’ senior vice president of global marketing and international sales. “To diagnose patients, especially those that will have signs or symptoms of respiratory illness, molecular assays will continue to be the Cadillac of tests and the primary choice for clinicians.”
The firm said recently that it is increasing capacity for the upcoming flu season and expects to exit 2020 producing up to 150,000 tests per month. GenMark has three manufacturing lines and expects to add a fourth in the middle of the fourth quarter.
Meantime, Waltham, Massachusetts-based Thermo Fisher Scientific is developing multiplex panels that it believes will be ready for the current respiratory seasons. A three-target panel for the US market includes tests for SARS-CoV-2, flu A, and flu B, and a second panel for the European market includes targets for SARS-CoV-2, RSV, and flu A and flu B, but doesn’t differentiate between the flu subtypes. The company anticipates applying the same manufacturing ramp-up approaches for the multiplex panels as for its current authorized SARS-CoV-2 tests, said Rachel Formosa. who leads Thermo Fisher’s marketing initiatives associated with its COVID-19 and flu products.
Multiplex testing is important for labs because it can add efficiencies to workflows and reduce consumption of components such as swabs, said Israel Figueroa, product manager for Thermo Fisher’s COVID-19 multiplex kits. “The alternative option is to run separate kits that are specific for each condition, but that increases testing complexity and consumption of components.”
Qiagen’s Manissero said that during past flu seasons, rapid flu antigen testing and single-plex PCR tests for influenza-like illness have played a screening role at the point-of-care, but in the coming flu season, “molecular testing and particularly PCR-based assays are most likely to continue driving testing.”
Late in March, Hilden, Germany-based Qiagen received FDA EUA for its QiaStat-Dx Respiratory SARS-CoV-2 Panel for use in diagnosing patients infected with the coronavirus that causes COVID-19. The panel detects 22 viral and bacterial respiratory targets including SARS-CoV-2, flu A, flu B, and RSV.
Austin, Texas-based Luminex has been marketing its NxTag CoV Extended Panel since March when it received FDA EUA, and laboratories are running that test in parallel with the Luminex NxTag Respiratory Pathogen panel to simultaneously detect 20 respiratory pathogens, including multiple influenza subtypes.
The company said recently that it expects to soon obtain FDA EUA for additional tests that it has developed and that it intends to market during the upcoming respiratory season. One is a consolidated respiratory panel that includes a coronavirus target called the NxTag RPP plus SARS-CoV-2. The second is a standalone SARS-CoV-2 assay running on the Verigene I instrument that can be run alongside the current Verigene respiratory pathogens flex-testing panel.
Luminex also plans to apply for FDA EUA for a respiratory panel with a SARS-CoV-2 target running on its next-generation Verigene II molecular instrument. The Verigene II test is a fully automated, sample-to-answer system with 23 respiratory targets, including influenza and SARS-CoV-2.
The “all-in-one” panels reduce the number of samples, lowering patient discomfort, and providing for faster, more comprehensive testing while cutting down on the number of required suppliers, Shapiro said.
In July, Miller’s BioMérieux announced that its all-in-one BioFire Respiratory Panel 2.1 plus, which tests for SARS-CoV-2 and other respiratory infections, received CE marking. The panel tests for 23 pathogens encompassing 19 viruses, including SARS-CoV-2 and Middle East Respiratory Syndrome coronavirus, and four bacteria that result in the most frequent respiratory tract infections. An earlier version of the test received FDA EUA in May.
The CDC, which was first to receive EUA for a coronavirus test in February, also nabbed one for a molecular SARS-CoV-2-flu test in July.
Further, Cepheid, part of Washington, DC-based Danaher, has plans to launch a rapid 4-in-1 test for detection of the coronavirus, flu A, flu B, and RSV from a single patient sample, and Roche announced Friday that its Cobas SARS-CoV-2 & Influenza A/B test received FDA EUA. The multiplex test is also available in countries accepting the CE mark
On Monday, three companies announced the development of multiplex respiratory panels. Laboratory Corporation of America said it has developed a single-panel molecular test to detect COVID-19, influenza A/B, and RSV infections, available to patients in the US through doctors, hospitals, and other authorized healthcare providers. LabCorp has submitted an application to the FDA to enable it to offer the combined test through its Pixel by LabCorp at-home test collection kit, which uses a short swab that is inserted into the lower nostril.
Further, Seoul, South Korea-based Seegene said it has introduced a single tube real-time RT-PCR assay, the Allplex SARS-CoV-2/FluA/FluB/RSV test, that simultaneously detects and differentiates flu A, flu B, RSV A/B, and three different target genes of COVID-19 ─ the S gene, RdRP gene, and N gene.
Additionally, CerTest Biotec, based in Zaragoza, Spain, announced it has developed the Viasure SARS-CoV-2, Flu & RSV Real-Time PCR detection kit.