Could Roche’s malaria test help address the national blood shortage?

Understanding the Ongoing Blood Shortage

In September 2023, the American Red Cross announced a national blood shortage in the US, stating that donations had dropped 25% from early August 2023. At the time, the organization attributed these shortages to an increased number of climate disasters, which resulted in canceled or closed blood drives or donation centers.

On January 7, 2024, the American Red Cross disclosed yet another national blood shortage, revealing its plans to leverage technology to address the shortage.

However, the challenges of the donor shortage have persisted. On August 5, 2024, the organization announced that the national blood inventory dropped 25% throughout July 2024, presenting further challenges.

While multiple factors, including climate-related events, may perpetuate these shortages, Higgs discussed a few contributors with LifeSciencesIntelligence.

 "Most blood donors are older adults. As this population ages, they increasingly need blood products themselves. This shift — where those who once donated are no longer able to, but now require more blood — combined with the growing number of elderly individuals, is putting significant strain on the system," she explained.

Another factor influencing the blood shortage is the shift to remote work triggered by the pandemic. More remote workers mean that fewer donors encounter fixed and mobile blood drives.

“Historically, blood centers have collected through at their fixed sites, through mobile drives that go out to the workplace or other community organizations, and they're having to change how they reach out to the population. The workplace blood drives are not as effective as they were pre-COVID.”

Managing the Blood Shortage

Although blood shortages present several challenges, many strategies have been used to address the shortage and bolster the national blood supply. Higgs explained multiple strategies, ranging from early donation to diagnostic tools that expand the potential donor pool.

Introducing Donations Early On

To start, Higgs explained that more attention should be allocated to blood drives and donations in high schools. In some states, individuals as young as 16 are eligible to donate blood, and introducing donation early in life can facilitate a longitudinal commitment to donation.

“Many individuals have that drive to help other people. And tapping into that at a younger age helps instill that long-term desire to give in ways,” she highlighted.

Blood Rationing

Although blood rationing does not necessarily address ongoing blood shortages, it can help healthcare facilities with a limited blood supply manage shortages until the supply has been replenished.

Higgs explained that the people who need blood can be broadly divided into three groups: (1) individuals who have been in a traumatic accident or are experiencing some sort of physical trauma, (2) individuals with a long-term illness that requires blood transfusion or blood products, and (3) individuals going in for routine or “elective” surgeries, such as knee replacements, hip replacements, and other surgeries.

When blood shortages occur, the first course of action to preserve the existing blood supply is to cancel or postpone elective surgeries.

“The first thing that happens is those elective surgeries are canceled. That impacts the older population more because they're the ones that are typically needing the hip replacements, the knee replacements, or the elective surgeries that might require blood.”

Roche’s Malaria Test

Beyond elderly populations, other patient demographics are disproportionately impacted by the blood shortage. For example, being from or traveling to endemic areas for malaria is one of the reasons some donors are deferred from donation. Higgs explained that the deferral affects specific populations more than others, namely, African American patients.

“That's where the diversity in the blood supply becomes a topic [of discussion]. Sickle cell patients, typically African American, need more closely matched blood [as they receive more transfusions].”

That is where diagnostic tools, such as Roche’s Cobas malaria test, can help to expand donor eligibility while maintaining a safe blood supply.

“Our mission within Roche donor screening is to provide tools that help blood centers focus on blood safety or availability,” noted Higgs.

Roche’s newest malaria test addresses both components by screening more patients who would have previously been deferred from blood donation and ensuring that the blood supply remains safe.

 “The Cobas malaria test was designed to include more individuals from malaria-endemic regions, often in Africa, into the donor pool. This approach helps to better support that population and improves patient outcomes by allowing for more closely matched blood donations.”

For this test, donors previously deferred for malaria risk would present blood for collection. A blood sample is sent to the lab to test for malaria. If the sample is negative, the donated blood can join the donor pool, but if it is positive, the units would be destroyed, and the donor can be counseled with information on malaria.

"The test is designed to detect all five primary species of malaria that affect humans," said Higgs. "It is highly specific to malaria and does not cross-react with other infectious agents. The test is also very sensitive, ensuring that anyone infected and at risk of transmitting malaria to a vulnerable patient can be identified and deferred."

Although the FDA has not issued guidance on using this test for assessing donor eligibility, Higgs told LifeSciencesIntelligence that a draft guidance is expected by the end of the year.

 "Once implemented, this should provide blood centers with the tools to balance maintaining availability, welcoming eligible blood donors, and minimizing the risk of infectious disease."

As the blood shortage continues to cause disruptions in healthcare, leveraging all the available tools to end the shortage will be critical to restoring the national blood supply and alleviating the burden on hospitals and healthcare facilities.