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Roche receives FDA approval for first whole blood test

The U.S. Food and Drug Administration (FDA) has given Roche the green light for its cobas Babesia test, the first commercial whole blood test for donor screening. The test is meant to reduce the risk of transmitting the Babesia parasite through blood transfusions.

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Image credit: Roche

Roche announced in a media release that it has received FDA approval for its cobas Babesia whole blood test. The test can detect the four most common species of Babesia, a parasite that lives in red blood cells. The Babesia parasite cannot be detected in traditional plasma or serum samples.

According to Roche, the parasite is most commonly transmitted to humans through the bite of an infected tick, but it can also be transmitted through blood transfusions or from mother to fetus during pregnancy. In healthy people, the infection is often asymptomatic or causes a range of mild flu-like symptoms. However, in elderly or otherwise immunocompromised patients, it can lead to life-threatening complications. For this reason, early detection of the Babesia parasite from blood donors is key.

The cobas Babesia test is Roche’s first commercially available whole blood test for individual blood donation testing. It is meant to help healthcare professionals reduce the potential risks of infection from transfused blood products and help customers improve lab efficiency.

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