USA – Hologic and Thermo Fisher Scientific have received CE- in vitro diagnostic (CE-IVD) marking for their respective RT-PCR-based respiratory virus assays.
Hologic is rolling out two molecular diagnostic panels at once. It received CE-IVD marking for its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and its Novodiag RESP-4 molecular diagnostic test, both of which detect and differentiate SARS-CoV-2, influenza A and B, and respiratory syncytial virus.
Both diagnostics require nasopharyngeal swab samples and can begin returning results within one to three hours.
The Panther Fusion assay runs on the company’s high-throughput Panther Fusion system while the Novodiag RESP-4 assay runs on the Novodiag system, which runs up to 16 samples simultaneously.
“The RESP-4 assay, developed and manufactured in Espoo, Finland, is the first new Novodiag assay to be launched since Hologic’s acquisition of Mobidiag in June 2021,” Jan Verstreken, Hologic’s group president, said in a statement.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay was developed and will be manufactured at Hologic’s facility in San Diego.
Thermo Fisher, meanwhile, rolled out just one supersized molecular diagnostic. The test runs on Thermo Fisher’s Applied Biosystems PCR analyzers and return results in about three hours. The analyzers can run up to 94 of the panels at once.
As the world continues to grapple with living alongside COVID-19, it is important to know that there are a myriad of other respiratory viruses that can also cause serious illness.”
Thermo Fisher’s Applied Biosystems TaqPath Respiratory Viral Select Panel tests for adenovirus, human metapneumovirus, rhinovirus and enterovirus, and parainfluenza virus.
“As the world continues to grapple with living alongside COVID-19, it is important to know that there are a myriad of other respiratory viruses that can also cause serious illness,” Manoj Gandhi, senior medical director of Genetic Testing Solutions at Thermo Fisher, said in a statement.
Offering information on these other common respiratory viruses in a single test empowers labs to detect them quickly and efficiently.
Furthermore, Accelerate Diagnostics also has received the CE mark for its Accelerate Arc Module and BC kit, which is designed for the rapid microbial identification of positive blood cultures through MALDI mass spec instruments.
Accelerate’s Accelerate Arc Module uses inline centrifugation and automated sample prep techniques that work together with the blood culture kit to provide a suspension of cleaned microbial cells that can be directly transferred to a MALDI spotting plate.
Using Accelerate Arc Module, the total cost to rapidly identify organisms from positive blood cultures is significantly less than what laboratories are paying today for a rapid molecular ID solution.
The Accelerate Arc Module and BC kit was recently registered with the US Food and Drug Administration.
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