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News items for the in vitro diagnostics industry for the week of Nov. 23, 2020.
The FDA cleared a CellaVision test that provides differential counts of white blood cells, characterization of red blood cell morphology, and platelet estimations.
The deal comes one week after the Netherlands said it was buying 9.2 million of the tests. The Canadian government is also purchasing 2,172 BD Veritor Plus Systems.
According to some analysts, the selloff in IVD company shares may be an overreaction, and SARS-CoV-2-related testing will be needed for some time in the future.
For the full year, the Franklin Lakes, New Jersey company saw a decline in revenues of 1 percent compared to 2019.
The order is the first from a European government following CE-IVD mark in September. The firm expects to ship 1.2 million of the assays by mid-November.
The firms previously received CE mark for a COVID-19 test on the BD Max system in March.
The BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes has been used for more than a decade to assess immune function in HIV patients.
The Italian diagnostics firm believes its test can ID patients with high viral loads rapidly who need to be treated quickly.
Fujirebio Diagnostics got the nod for a chemiluminescent enzyme immunoassay to measure levels of CA 15-3 and manage patients diagnosed with breast cancer.