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Hologic, Thermo Fisher, Accelerate Diagnostics Products Get CE Marks

NEW YORK — Hologic and Thermo Fisher Scientific announced separately on Monday that they have received CE-IVD marking for their respective RT-PCR-based respiratory virus assays.

Accelerate Diagnostics also said on Monday that it 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.

Hologic 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 using nasopharyngeal swab samples.

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 our facility in San Diego."

Thermo Fisher's Applied Biosystems TaqPath Respiratory Viral Select Panel tests for adenovirus, human metapneumovirus, rhinovirus and enterovirus, and parainfluenza virus. It runs on the Applied Biosystems QuantStudio 5 PCR system and can process up to 94 samples at a time.

"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."

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 our system, 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," John Meduri, chief strategy officer at Accelerate, said in a statement.

The Accelerate Arc Module and BC kit was recently registered with the US Food and Drug Administration.