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2022-08-22| TechnologyTrending

Growing Number of Monkeypox Tests Available to Researchers

by Reed Slater
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As global monkeypox cases continue to creep past 40,000, more companies are developing monkeypox tests for research purposes. Some of the most recent additions include GenScript USA’s monkeypox virus PCR test kit and Germany-based Qiagen’s syndromic test kit that differentiates between monkeypox and five other viruses with similar profiles. 

GenScript’s Efforts to Help Quell the Monkeypox Outbreak

According to the CDC, the US has confirmed over 14,000 monkeypox cases with zero deaths so far. Still, on August 4, US Department of Health and Human Services Secretary, Xavier Becerra, declared the monkeypox outbreak a public health emergency. Companies, researchers, and government organizations are working day and night to understand the virus’ transmission to stop the spread. 

GenScript’s newest addition to the monkeypox test lineup is a PCR test developed alongside Anbio Biotechnology for research use only (RUO). Along with research use in the US, the test is available in the EU after it received the CE mark, a required designation for all medical devices and tests in Europe. 

Senior product manager of diagnostics at GenScript, Amanda Grimm, said, “Providing access to commercial test kits is essential so that we can quickly detect and understand how the virus is moving through our communities. We are rushing supplies of the monkeypox PCR test kit to our lab customers and distributors because diagnostic labs across the United States are a crucial element of the nation’s response to this public health emergency.”

GenScript designed the test to take various sample types, including the FDA-recommended lesion swab samples. The test also amplifies two conserved gene regions of the monkeypox virus with fluorescent probes, making the test easier for researchers to use. 

Related Article: EMA Announces Advice on Switch that Could Increase The Monkeypox Vaccine Supply

Global Attempts to Understand Monkeypox

Despite the US having the most confirmed monkeypox cases of any country, the virus is affecting global communities after regulatory agencies worldwide have reported cases in 94 countries, 87 of which have not historically reported monkeypox cases. Companies like Germany’s Qiagen are doing their part to add to the global knowledge pool of monkeypox and its transmission.

Qiagen designed a PCR test that differentiates between the two common monkeypox viruses (West African and Congo Basin clades), herpes simplex virus 1 and 2, human herpesvirus 6, varicella-zoster virus, and enterovirus. The company designed the test, which it calls QIAstat-Dx Viral Vesicular Panel, with these viruses in mind because they all result in similar symptoms and produce similar-looking vesicular lesions. 

Like GenScript’s test, Qiagen’s new test is for RUO. Researchers worldwide will have the opportunity to use the comprehensive test on some of the 3,000+ QIAstat-Dx automated syndromic testing devices.

Though the QIAstat-Dx Viral Vesicular Panel is only approved for research purposes, for the time being, Qiagen said it is ready to develop applications for clinical use if authorities in the US and Europe decide to open the door to new diagnostic pathways. 

With the continual rise of monkeypox cases worldwide, there is more focus now than ever on developing new tests and techniques to study the virus to stop the spread of the current outbreak and prevent future outbreaks of viral diseases. GenScript’s PCR test and Qiagen’s multi-virus screening test are valuable additions to understanding the current monkeypox virus outbreak.

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