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Roche Packs New FDA-Approved Test in Its Arsenal

The Basel, Switzerland-based company’s cobas Babesia test is a qualitative in vitro nucleic acid screening test for the direct detection of Babesia DNA and RNA in whole blood specimens from individual human blood donors.

Roche has won a nod from FDA for a new diagnostic for individual blood donation testing. The Basel-Switzerland-based company’s cobas Babesia test is for use on the cobas 6800/8800 system.

Cobas Babesia detects parasites that live in red blood cells. Roche said this test is an important advancement because the Babesia parasite cannot be detected in traditional plasma or serum samples. The test can detect the four-common species of Babesia and employs the new whole blood collection tube, which simplifies Babesia sample preparation by consolidating steps within the tube itself to provide an efficient solution for testing laboratories.

In most cases, the Babesia parasite is transmitted to humans through the bite of an infected tick; however, the parasite can also be transmitted through blood transfusions or from mother to fetus during pregnancy.

The parasite infects and destroys red blood cells which can lead to anemia and related life-threatening complications, particularly in the elderly or otherwise immunocompromised patients. In healthy people, the infection can be asymptomatic, or cause a range of mild flu-like symptoms.

“We are dedicated to helping save patients’ lives by providing advanced solutions to enable the protection of the global blood supply from infectious diseases. With the approval of Roche’s first whole blood test used in blood screening we can help healthcare professionals further diminish potential risks of infection from transfused blood products,” Thomas Schinecker, CEO Roche Diagnostics, said in a release. “In addition, we hope to help customers improve their lab efficiency by simplifying sample prep while ensuring maximum detection of infectious pathogens in the blood and the safety of the blood supply for the patients we serve.”

FDA’s approval comes on the heels of Roche expanding its Global Access Program to increase the availability of diagnostic tests for tuberculosis, hepatitis, and human papillomavirus (HPV) in underserved countries. Originally, the program was launched in 2014 and was established to increase the availability of HIV diagnostics.

The approval also follows Roche announcing a collaboration with GE Healthcare to develop oncology solutions. The duo’s first project is the Navify Tumor Board, a solution that allows teams who determine treatment plans for cancer patients - to have a more comprehensive view of each patient in one place.

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