2024-03-28| Trials & Approvals

Roche Delivering on Malaria Screening Solutions for Blood Donation

by Bernice Lottering
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Credit: F Hoffmann-La Roche.

In a recent win against malaria (Plasmodium), Roche has received FDA approval for the first-ever molecular test to screen U.S blood donors. The cobas® Malaria test is capable of providing a highly sensitive, highly specific solution to specifically assist healthcare professionals in reducing blood transfusion associated risks. 

A Revolutionary Approach in Safeguarding Blood Donation

Manufactured by Roche, the cobas® Malaria test, is an assay that enables the detection of infected blood units to be flagged for removal from the blood donation supply. Aiming to enhance blood safety and availability for recipients, this test appears to be capable of rapidly identifying malaria and is designed for screening blood, organ, and tissue samples.

Essentially, whole blood samples are screened for the five main species of Plasmodium parasites that cause human malarial infection. This novel testing system stands apart from various tests that exist on the market today in that it is specifically designed for use on donor materials. Currently, screening methods for malaria primarily focus on diagnosing individuals in order to facilitate prompt treatment and prevent further transmission. As testing systems continue to evolve and advance, those specifically designed for screening donors are encountering several limitations that may have a negative impact on donation systems.

Malaria in the Current Context

Malaria, a life-threatening disease transmitted by infected mosquitoes, poses a considerable global health threat. Despite recent advancements, malaria remains one of the deadliest diseases worldwide. In 2022, the number or deaths stood at around 608,000 and an estimated 249 million cases – an increase of over 5 million from 2021. The World Health Organization (WHO) reports that nearly half of the global population faced malaria risk in 2022. Here, it was observed that sub-Saharan Africa bears a disproportionately high burden, but Southeast Asia, the Eastern Mediterranean, the Western Pacific, and the Americas also reported significant malaria cases. Currently, one of the persistent challenges with malaria in the context of blood donation is that large numbers of potential donors are excluded as a result of travel histories to or from malaria-endemic regions.

In an effort to reduce transfusion-transmitted malaria, blood donation systems employ various screening measures for this disease to ensure the safety of the blood supply. Existing screening methods often rely on questionnaires about travel history and potential exposure to malaria-endemic areas, which may not always accurately identify donors at risk. Moreover, microscopic examination, RDTs, and molecular tests are also employed in blood donation screening, but their limitations, such as sensitivity issues and the need for specialized equipment, persist in this setting as well. 

Additionally, an added issue that further compounds malaria screening in blood donation systems is the prevalence of malaria in regions that are thought to be very low risk. Instances of locally acquired malaria in individuals with no international travel histories are not unheard of, and highlight emerging concerns. This pattern of events shows that whilst malaria is typically acquired when traveling to certain locations, domestic incidents could have detrimental impacts on the various realms of healthcare. Experts weigh in that the potential impact of warming temperatures on vector-borne diseases like malaria could increase indigenous case numbers in the coming years.

Moving toward a Better Blood Bank

The cobas® test offers a qualitative in vitro nucleic acid screening for malaria, directly detecting Plasmodium RNA and DNA in whole blood samples from individual human donors. It can be integrated with routine blood donor screening tests. However, it’s important to note that the test is not intended for diagnosing Plasmodium infection, nor is it suitable for cord blood samples or cadaveric blood specimens. The system will enable donors to undergo direct draws, enhancing workflow efficiency and reducing affiliated workloads associated with sample testing in this regard. 

Given the current issues surrounding malaria in donation systems, this advance could prove fruitful in assisting with blood safety protocols. This sector holds promise for continued advancements in the future. Roche anticipates availability of the test in the United States by the end of Q2 2024, with approval in CE-marked countries expected later in the year.

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