FDA Approves Roche’s Groundbreaking Molecular Test for Malaria Screening in Blood Donors

Roche, a leading healthcare company (SIX: RO, ROG; OTCQX: RHHBY), has announced today the approval by the U.S. Food and Drug Administration (FDA) for its cobas® Malaria test, designed for use on the cobas® 6800/8800 Systems. This milestone marks the first FDA-approved molecular test for malaria screening in blood donors. The cobas Malaria test offers healthcare professionals a highly sensitive and specific solution to detect the presence of Plasmodium parasites in whole blood samples, reducing the risk of infected blood units entering the blood supply and potentially infecting patients.

By screening for the five main species of Plasmodium parasites known to cause human infection, the cobas Malaria test enhances blood safety and availability. It is intended for use in screening blood, organ, and tissue donors, providing a crucial tool to mitigate the risk of malaria transmission through transfusions.

Matt Sause, CEO of Roche Diagnostics, emphasized the significance of this approval, stating, “As the first FDA-approved blood screening test for malaria, this represents an important step forward in safeguarding the global supply of donated blood.” The approval of the cobas Malaria test marks a substantial advancement in malaria detection, offering healthcare professionals a reliable method for donor screening and enhancing patient safety worldwide.

Existing microscopy and serological tests often lack the sensitivity required to effectively mitigate malaria transfusion risk. Roche’s Blood Safety Solutions offering, with its comprehensive molecular and serological testing options, addresses this gap in the US market.

Globally, a significant number of potential blood donors are disqualified due to travel to or from malaria-endemic regions. With an estimated 249 million cases of malaria in 2022 and 608,000 deaths, the disease remains a substantial public health challenge, particularly in sub-Saharan Africa. However, regions such as Southeast Asia, the Eastern Mediterranean, the Western Pacific, and the Americas also report significant malaria cases and deaths.

The cobas Malaria test is expected to be available in the United States by the end of Q2 2024, with anticipated approval in CE-marked countries later in the year.

The cobas Malaria test is a qualitative in vitro nucleic acid screening test designed to detect Plasmodium RNA and DNA in whole blood samples from individual human donors. It can be performed alongside routine blood donor screening tests and is optimized for use on the cobas 6800/8800 Systems in the U.S. The test is not intended for diagnosing Plasmodium infection, nor is it suitable for use on cord blood samples or cadaveric blood specimens. Utilizing the Roche Whole Blood Collection Tube, the test enables direct draw from the donor and seamless integration with the cobas 6800/8800 Systems for enhanced workflow efficiency.

About the cobas 6800 and cobas 8800 Systems: Since 2014, the cobas 6800 and cobas 8800 Systems have set the standard for routine molecular testing, offering fully integrated, automated solutions across various healthcare domains, including donor screening, infectious disease, sexual health, transplant, respiratory, and antimicrobial stewardship. The current molecular donor screening assay menu includes cobas® MPX, cobas® DPX, cobas® HEV, cobas® WNV, cobas® CHIKV/DENV, cobas® Zika, and cobas® Babesia (availability varies by region).

Malaria is a severe and potentially fatal disease caused by a parasite commonly transmitted through the bites of infected mosquitoes. Symptoms include high fever, chills, and flu-like symptoms. Malaria can also spread through blood transfusions, organ transplants, or the shared use of contaminated needles or syringes. While preventable and curable, malaria remains a significant global health challenge, with Plasmodium falciparum and Plasmodium vivax posing the greatest threat among the five parasite species that infect humans.

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