The FDA granted its third emergency authorization for a clinical monkeypox diagnostic to a high-throughput molecular lab test developed by Roche.
The latest green light follows an October authorization handed to Abbott and its PCR test as well as one in September given to Quest Diagnostics.
During that time, the nationwide number of confirmed cases has steadily declined from its high point during the summer. According to the Centers for Disease Control and Prevention, the seven-day average of positive monkeypox results dropped to just 13 as of Nov. 16, down from more than 450 per day in early August. In total this year, the U.S. has logged more than 29,000 cases and 11 deaths.
Roche’s real-time PCR test detects the DNA of the monkeypox virus taken from swabs of skin lesions and runs on the company’s automated cobas 6800/8800 systems. The company said in a release that its test was the first authorized diagnostic to be developed using live patient samples instead of samples formulated in a lab.
The Swiss company previously rolled out three research-use-only tests in May, after clusters of the virus first began to be detected worldwide. Those three PCR tests were developed with its subsidiary TIB Molbiol—a company that specializes in quickly turning around diagnostics for emerging infectious diseases—which was acquired by Roche in September 2021 following a history of partnerships, including in COVID-19.
Monkeypox, a member of the same family of viruses as smallpox, produces a painful rash that can be mistaken for diseases such as chickenpox, measles and other bacterial skin infections as well as hives or allergies. Other signs and symptoms include fever, chills, headaches and muscle pains.