Roche’s first blood donation testing system gets FDA approval

Roche’s first blood donation testing system gets FDA approval

7:19 AM, 20th September 2019
Roche Logo

BASEL, SWITZERLAND: Roche Holding AG has received approval from the US Food and Drug Administration (FDA) for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation testing.

This is Roche’s first commercially available whole blood test to screen donations. cobas Babesia detects parasites that live in red blood cells. This test is an important advancement because the Babesia parasite cannot be detected in traditional plasma or serum samples. The test is able to 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 foetus during pregnancy. The parasite infects and destroys red blood cells which can lead to anaemia 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,” said Thomas Schinecker, CEO Roche Diagnostics. “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.”

The Roche Blood Safety Solutions offering now provides the most comprehensive testing solution for blood donor screening utilising the fully automated cobas 6800/8800 System. This novel test approval follows the successful launch of the cobas Zika test, which was the first Zika test available for donor screening in the US. This new Babesia test expands the menu of tests available for the cobas 6800/8800 Systems for use in US donor screening laboratories.

Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of donor screening, infectious disease, sexual health, transplant, respiratory and antimicrobial stewardship.

© Worldofchemicals News

0 Comments

Login

Your Comments (Up to 2000 characters)
Please respect our community and the integrity of its participants. WOC reserves the right to moderate and approve your comment.

Related News


SRF shuts technical textiles plant in Thailand

GURUGRAM, INDIA: SRF Ltd, a leading manufacturer of technical textiles, engineering plastics, chemicals and packaging films, has decided to shut opera ...

Read more
Polynt announces strategic integration initiative in Americas

CARPENTERSVILLE, US: Polynt-Reichhold Group has decided to expand the successful integrated business model it employs in Europe and Asia to its operat ...

Read more
HMG Paints launch commercial vehicle topcoat, Acrythane 4G

MANCHESTER, UK: HMG Paints Ltd, the UK’s largest Independent paint manufacturer, has launched a revolutionary, one visit application, commercial ...

Read more
Hempel launches new coating for superior protection against corrosion

HOUSTON, US: Hempel announced the launch of Hempatop Direct 460 in North America. Developed to provide superior protection against corrosion ...

Read more
Eni starts gas production of Baltim South West field offshore Egypt

ROME, ITALY: Eni SpA has successfully started-up production from the offshore Baltim South West gas field in Egypt. Discovered by Eni in June 2016, th ...

Read more
Laurus Labs to acquire the Aspen Pharmacare subsidiary in South Africa

HYDERABAD, INDIA: Laurus Labs has agreed to acquire 100 percent shares of Phekolong Pharmaceuticals Pty Ltd, a wholly owned subsidiary company of Phar ...

Read more
www.worldofchemicals.com uses cookies to ensure that we give you the best experience on our website. By using this site, you agree to our Privacy Policy and our Terms of Use. X