Roche has secured approval from the US Food and Drug Administration (FDA) for its cobas Babesia test to run on the cobas 6800/8800 Systems for individual blood donation testing.

The cobas Babesia is claimed to be the company’s first commercially available whole blood test to screen donations and follows May’s 2019 FDA-updated industry guidance recommending screening and testing for Babesia to decrease the risk of transmitting the parasite via transfusions.

Roche’s cobas Babesia qualitative in vitro nucleic acid screening test

The cobas Babesia is a qualitative in vitro nucleic acid screening test to directly detect Babesia DNA and RNA in whole blood specimens from individual human blood donors.

Roche’s cobas Babesia holds the capacity to detect parasites, which live in red blood cells. The test, which can detect the four common species of Babesia, uses the new whole blood collection tube to simplify Babesia sample preparation by consolidating steps within the tube, helping to offer a better solution for testing laboratories.

Babesia parasite is mostly transmitted to humans through the bite of an infected tick. It will also be transmitted through blood transfusions or from mother to foetus during pregnancy.

The parasite will infect and destroy red blood cells that may cause anaemia and related life-threatening complications, specifically in the elderly or otherwise immunocompromised patients.

The company already provides cobas Zika test for donor screening in the US. Different tests such as cobas MPX, cobas WNV and cobas Zika can run on the cobas 6800/8800 systems.

Roche Diagnostics CEO Thomas Schinecker said: “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.”

In April this year, Roche introduced a new Ventana HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in breast and gastric cancer patients.