June 28, 2022

In the fight against global disease outbreaks, diagnostic testing is an unsung hero. Validated testing is essential to get people the care they need and to stop the spread of disease.

Monkeypox is the latest target. Mayo Clinic Laboratories is validating diagnostic testing for the disease, which has sickened more than 1,600 people in 35 countries.

"We have the expertise and innovation to respond quickly to these needs," says Matthew Binnicker, Ph.D., director of Clinical Virology at Mayo Clinic. "When COVID-19 hit, we pulled together a team of about 15 people that was able to develop, validate, and get a test implemented in three weeks. We're leveraging that experience to validate and implement monkeypox testing."

Monkeypox is caused by a virus closely related to the smallpox virus. The risk of catching monkeypox in the United States is currently low, and the virus is unlikely to cause a worldwide pandemic on the scale of COVID-19. But for public health care organizations and scientists, monkeypox is a concern at a global level.

"Although monkeypox has been around for decades, this outbreak is different," Dr. Binnicker says. "Usually there's just a smattering of cases that remain geographically isolated. This time, we have more than 1,600 cases in multiple countries, which is much greater spread. When the monkeypox diagnostic test is validated, our hope is that it will help physicians manage their patients and reduce the spread of the disease."

A streamlined process

Identifying which individuals have a viral infection requires highly accurate laboratory testing. The sooner a test is validated, the sooner people can be reliably diagnosed — and the outbreak can be controlled.

Mayo Clinic Laboratories' rapid response to public health threats has been honed during outbreaks of viruses like 2009’s H1N1 influenza, Zika, Ebola and, most recently, COVID-19. Before COVID-19, laboratory staff were already experts in developing and implementing new tests — but never on such an aggressive timeline.

With COVID-19's rapid spread and the initial lack of vaccines, there was an especially urgent need for validated diagnostic testing. Without sacrificing safety or accuracy, Mayo Clinic Laboratories streamlined its test development process.

"In the past we would develop and validate testing one step at a time, very much in a linear fashion," Dr. Binnicker says. "With COVID-19, we looked at that process and asked how we might collapse it — what parts of the work could be done at the same time and then pulled together at a later stage, to move from start to finish more quickly."

A similar approach has been applied to validate monkeypox testing. "We have a number of people working simultaneously on their own parts of the process so that everything is ready as quickly as possible," Dr. Binnicker says.

State-of-the-art technology is also key. Mayo Clinic Laboratories is a leader in the use of molecular testing to diagnose infectious diseases.

"Some of the technology we brought into our labs during COVID-19 is the same technology needed for monkeypox testing," Dr. Binnicker says. "It was a good turn of fortune that we have that equipment and can now pivot and use it for monkeypox."

Looking ahead

One reason for COVID-19's rapid spread is that people who have the virus can be asymptomatic. Without realizing they are sick, these individuals can spread the infection to others. In contrast, monkeypox infection generally causes a skin rash that might prompt people to see a doctor. In addition, the disease isn't believed to be spread efficiently by asymptomatic people.

But diagnostic testing for monkeypox is still needed. The monkeypox rash is similar to rashes caused by other viruses, such as herpes. Validated testing can confirm the diagnosis of monkeypox, and guide decisions about treatment and precautions to prevent spread.

"Monkeypox case counts are likely to grow, and physicians will need to consider monkeypox as a possible cause of patients' illness," Dr. Binnicker says. "Having a precise diagnosis helps our physicians care for their patients."

In an era of global travel, future disease outbreaks seem likely. "Most infectious diseases experts believe it's a matter of when — not if — there will be another outbreak of a novel infectious disease," Dr. Binnicker says.

Mayo Clinic Laboratories is prepared. "We have a global view and the right people around the table to respond quickly," Dr. Binnicker says. "We step up in difficult times, not only for our Mayo Clinic patients but for people around the world."