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T2 Biosystems (TTOO) to Explore Potential to Develop Rapid Molecular Diagnostic Test for Monkeypox Virus

August 9, 2022 8:33 AM EDT

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T2 Biosystems, Inc. (NASDAQ: TTOO) a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today plans to explore the potential to develop a rapid molecular diagnostic test for detection of the monkeypox virus, including technical and commercial feasibility. Monkeypox is a rare disease caused by infection with the monkeypox virus that is part of the orthopoxvirus family of viruses, which also contains smallpox. The main symptom of monkeypox is a rash, but individuals may also present with flu like symptoms. A rapid and accurate diagnosis of monkeypox is essential to expedite treatment and to limit exposure and spread of the disease.

On July 23, 2022, the World Health Organization declared the global monkeypox outbreak a Public Health Emergency of International Concern, which is the highest level of global health alert under International Health Regulations. On August 4, 2022, the United States declared monkeypox a public health emergency, a move that is expected to free up additional funding and tools to fight the disease.

“Our team has demonstrated the scientific expertise to develop new tests on our proprietary platform, including direct-from-blood and swab tests, and we believe the development of a molecular diagnostic test for the monkeypox virus is possible on our platform,” stated John Sperzel, Chairman and CEO of T2Biosystems. “Given the urgent nature of the monkeypox virus, and the potential for global transmission, we have communicated with the FDA and CDC and we are exploring the potential to develop and commercialize a test for the monkeypox virus.”

The U.S. Centers for Disease Control and Prevention (CDC) has the only FDA-cleared test that can detect monkeypox by a swab from a monkeypox lesion (rash or growth). This test is being offered through the CDC’s public health Laboratory Response Network. Additionally five large commercial laboratories have developed the CDC test on their platform or developed a Lab Developed Test (LDT). The FDA is working closely with the CDC to increase diagnostic testing availability for monkeypox.



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