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Credo Diagnostics Combo Influenza, COVID-19 Test Receives CE-IVD Mark

NEW YORK – Credo Diagnostics Biomedical announced Friday its combination VitaPCR Influenza A&B/SARS-CoV-2 test received CE-IVD marking. 

The point-of-care RT-PCR test delivers results from one nasopharyngeal sample in 20 minutes and can be used on the firm's VitaPCR instrument. The platform can perform 24 runs per day with one sample per run and doesn't need "highly trained personnel," Credo said in a presentation on the test.

The Singapore-based company said it can help decentralize testing in schools, emergency rooms, clinics, and other high-risk locations, and added it implemented the test at Paris Charles De Gaulle Airport in July and at the hospital and university IHU Méditerranée Infection in Marseille, France. 

"COVID-19, Flu A, and Flu B patients present similar symptoms, however they require very different approaches for triage, patient management, and treatment," Sofiane Bennacer, head of business development, said in a statement. "The ability to quickly and accurately detect and differentiate the three viruses is crucial to support the healthcare system and avoid its collapse."

Credo has also started to increase monthly production capacity to "millions of tests and thousands of instrument[s]." The firm is expecting Emergency Use Authorization from the US Food and Drug Administration and Emergency Use Listing from the World Health Organization, it said in a statement. The test has already begun shipping in Europe, it added.

The firm also has a VitaPCR SARS-Cov-2 test with CE marking that is being distributed by A. Menarini Diagnostics.