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Becton Dickinson Gets CE-IVD Mark for High-Throughput COVID/Flu PCR Test

NEW YORK – Becton Dickinson announced on Thursday that it has obtained the CE-IVD mark for a combined influenza, SARS-CoV-2 assay. The multiplexed RT-PCR test runs on the firm's high-throughput BD Cor system.

Called the BD SARS-CoV-2/Flu assay, the test detects and differentiates the virus that causes COVID-19 from both influenza A and B viruses. It runs on the BD Cor PX/MX system. The test can be performed using a nasal sample from either symptomatic or asymptomatic patients.

"As long as the COVID-19 pandemic persists or evolves to an endemic situation, testing for the virus will remain an important public health tool," said Celine Roger-Dalbert, VP of diagnostic assays R&D at BD, in a statement.

The combo test is the second CE-marked assay on the BD Cor MX/PX system. The modular Cor system can also be used with a module called GX which runs a cervical cancer screening test.

BD launched the MX instrument of the Cor in 2021 with a CE-marked multiplex assay for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV). Called BD CTGCTV2, that assay as well as the MX instrument also received 510(k) clearance from the US Food and Drug Administration earlier this month.

"The BD SARS-CoV-2/Flu assay is the first delivery on our promise to continue to expand assays that can be performed in high-throughput central testing labs," said Brooke Story, president of integrated diagnostic solutions for BD. "We will continue to broaden our available tests for the BD Cor System, including assays for other common STIs, overall women's health, and gastrointestinal infections," Story added.

Last year, BD and the US Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response Biomedical Advanced Research and Development Authority (BARDA) formed a public-private partnership, establishing a contract worth up to $40.3 million for BD to develop and obtain US regulatory clearance for five assays, including a SARS-CoV-2/influenza combo test on the Cor.

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