Monkeypox Test Kit in Development by Becton Dickinson in Partnership with CerTest Biotec

Leading global medical technology company Becton Dickinson (BD) and Spain’s CerTest Biotec have announced they will be collaborating to develop a molecular diagnostic test for the detection of the monkeypox virus.

In a joint press release, the companies said the aim of the partnership is to design a diagnostic test that can help advance understanding of the global spread of the disease.

The collaboration will involve BD helping develop and validate CerTest’s VIASURE Monkeypox CE/IVD molecular test on its BD MAX™ open system reagent suite.

CerTest Biotec specializes in the development and manufacturing of in vitro diagnostic medical devices and has expertise in the detection of human diseases.

As of June 23, there have been over 3,200 confirmed cases of monkeypox and one death reported to the World Health Organization (WHO).

The monkeypox virus is an orthopoxvirus that causes monkeypox infection, which has symptoms that are similar to smallpox, but less severe. As such, the smallpox vaccine can be used to protect against monkeypox — according to the WHO, the vaccine is 85 percent effective against monkeypox infection.

There is currently no commercial test available for the detection of the monkeypox virus.

Related: Monkeypox Case Reported in the US as Virus Spreads Across Europe and North America

Diagnostic testing for monkeypox is becoming a bigger need as cases of the infection continue to rise and appear in different parts of the world. Monkeypox is endemic to central and western Africa but is now circulating in countries outside of these regions for the first time in most cases.

BD’s BD MAX System is a fully integrated, automated nucleic acid extraction and real-time PCR platform that produces results in less than three hours. It can process up to 24 samples across multiple indications.

BD is a long-time leader in in vitro diagnostics and the company offers an extensive array of tests on its BD MAX system, which include healthcare-associated infections such as respiratory infections, sexually transmitted infections, gastrointestinal infections and women’s health diagnostics.

BD says it offers a “suite of open system reagents for the BD MAX System that enables labs to fully automate and streamline their Lab Developed Tests, and BD can partner with customers to develop complementary assays on the system.”

“Enabling labs to rapidly respond to unexpected challenges is the kind of evolving health care situations for which the BD MAX™ open system reagent suite is designed,” said Nikos Pavlidis, vice president of Molecular Diagnostics at BD in the statement. “Through our collaboration with CerTest and their ability to rapidly transfer assays on the BD MAX™ System, we will enable BD MAX™ System users around the world to access a test for the confirmation of monkeypox.”

Despite the rising number of monkeypox cases around the world, in a report from the Meeting of the International Health Regulations (2005) (IHR) Emergency Committee regarding the global monkeypox outbreak, held on June 23, 2022, the committee advised the Director-General (DG) of the WHO that, “at present, the outbreak does not determine that the event constitutes a Public Health Emergency of International Concern (PHEIC).”

The PHEIC is the highest alert level that the WHO can issue.

The DG of the WHO, Dr. Tedros Ghebreyesus, issued a statement on the report, acknowledging the advice of the Emergency Committee that the monkeypox outbreak does not warrant a PHEIC. However, he said the global health agency is closely monitoring the evolving situation.

In addition to BD, there are a handful of other companies developing molecular monkeypox tests in anticipation of a growing demand for them.

This includes F Hoffmann-La-Roche (Roche) and its subsidiary TIB Molbiol who have developed three LightMix Modular Virus test kits for the identification of the monkeypox virus using quantitative PCR technology. The first test can detect all orthopoxviruses, including smallpox, horsepox, cowpox and monkeypox while the second kit is specific to the identification of the monkeypox virus. The latter can also detect both the West African and the Congo Basin (Central African) clade of the virus.

The third kit is a combination of the other two, identifying the presence of orthopoxviruses and specifically clarifying or distinguishing the monkeypox virus if present.

While Roche’s monkeypox tests are not commercially available yet, they are available to scientists in most countries for research use.

Abbott Laboratories is also developing monkeypox test kits as is Trivitron Healthcare, a medical device company based in India which has developed a four-color fluorescence-based kit that can complete testing in one hour.

Although monkeypox does not cause severe infection in the majority of cases, the current outbreak has led to dozens of hospitalizations. Testing is therefore critical in tracing and following the trajectory of the virus, as well as for prevention and treatment.