• Sustainability
  • DE&I
  • Pandemic
  • Finance
  • Legal
  • Technology
  • Regulatory
  • Global
  • Pricing
  • Strategy
  • R&D/Clinical Trials
  • Opinion
  • Executive Roundtable
  • Sales & Marketing
  • Executive Profiles
  • Leadership
  • Market Access
  • Patient Engagement
  • Supply Chain
  • Industry Trends

FDA Approves Roche’s Cobas Malaria Test, Designed to Screen for Malaria in Potential Blood Donors


Action marks the first FDA-approved blood screening test for malaria.

The malaria-infected red blood cells. 3D illustration showing malaria parasite Plasmodium falciparum in schizont stage inside red blood cells, the causative agent of tropical malaria. Image Credit: Adobe Stock Images/Dr_Microbe

Image Credit: Adobe Stock Images/Dr_Microbe

Roche announced that the FDA has officially approved the Cobas Malaria test, focused on inspecting blood donors for malaria, aiming to enhance the safety of blood supply. The test, which screens blood samples for five species of Plasmodium parasites, is the first of its kind approved for this purpose and aims to reduce the risk of malaria transmission through transfusions. Roche stated that it expects the test to be available in the United States at some point during the second quarter of this year.1

“As the first FDA-approved blood screening test for malaria, this represents an important step forward in safeguarding the global supply of donated blood," said Matt Sause, CEO, Roche Diagnostics, in a press release. “The approval of cobas Malaria represents a significant advancement in malaria detection, offering healthcare professionals a reliable tool for donor screening and improving the safety of patients worldwide.”

According to the company, close to half of the global population was at risk for malaria in 2022, with substantial rates of mortality, especially in Africa. Other areas that reported significant numbers included Southeast Asia, the Eastern Mediterranean, the Western Pacific, and the Americas. Prior tests on the market weren’t able to pick up on malaria transfusion risks.1

According to the World Health Organization (WHO), children under 5 years of age made up 80% of all malaria-related deaths in Africa. Symptoms usually manifest around 10-15 days after getting bitten by an infected mosquito. Common symptoms of the disease include:

  • major fatigue
  • convulsions
  • struggles with breathing
  • bloody urine
  • abnormal bleeding
  • yellowing of the eyes and skin.2

“Malaria mostly spreads to people through the bites of some infected female Anopheles mosquitoes,” states WHO. “Blood transfusion and contaminated needles may also transmit malaria. The first symptoms may be mild, similar to many febrile illnesses, and difficulty to recognize as malaria. Left untreated, P. falciparum malaria can progress to severe illness and death within 24 hours.”

There are also multiple ways to prevent malaria, such as avoiding mosquitos and consulting a physician on medication. WHO also suggested multiple ways of avoiding mosquito bites, including netting mosquitos when sleeping in areas in which they are present, wearing protective clothing, and using repellant.2

“Since October 2021, WHO has recommended broad use of the RTS,S/AS01 malaria vaccine among children living in regions with moderate to high P. falciparum malaria transmission. The vaccine has been shown to significantly reduce malaria, and deadly severe malaria, among young children,” WHOexplained. “In October 2023, WHO recommended a second safe and effective malaria vaccine, R21/Matrix-M. The availability of two malaria vaccines is expected to make broad-scale deployment across Africa possible.”


1. Roche receives FDA approval for the first molecular test to screen for malaria in blood donors. Roche. March 26, 2024. Accessed March 27, 2024. https://www.roche.com/media/releases/med-cor-2024-03-26

2. Malaria. WHO. December 4, 2023. Accessed March 27, 2024. https://www.who.int/news-room/fact-sheets/detail/malaria#:~:text=Disease%20burden,to%20610%20000%20in%202021.

Related Videos
Ashley Gaines
Related Content