(Yicai Global) Nov. 17 -- China’s monkeypox detection set developers are encountering difficulties getting their products approved for clinical use due to a dearth of virus samples and the costs involved.

Many of the country’s monkeypox diagnostic reagents are limited to the lab at present as the process of getting approval for them to be used in the hospital is expensive and many developers will not take this step until they deem it to be profitable, an expert told Yicai Global.

Although China is unlikely to see a wave of monkeypox, the development of monkeypox reagents is still essential and will help prevent a pandemic, the person said.

Nicolas Berthet and Wang Songji at France’s Institut Pasteur have developed a number of rapid tests for monkeypox which can produce visually identifiable results within half an hour, according to a paper they published in the journal Viruses last month.

The team is keen to translate these detection methods into a marketable product as soon as possible, Berthet said. Monkeypox reagents are facing certain challenges, not only in China, but also in France. We need first to establish how reliable these methods are in actual practice, he added.

Despite the difficulties, there are products on the market. Swiss pharma giant Roche’s monkeypox test kit was granted approval for emergency use by the US Food and Drug Administration on Nov. 15. And Chinese developers, such as Zj Biotech, Sansure Biotech and Guangzhou Wondfo Biotech, supply to some overseas countries but none have had their products greenlit in China so far.

It is difficult to carry out clinical studies in China as there haven’t been any recent cases, industry insiders told Yicai Global earlier. And there is no dedicated channel for market registration, which means it takes a long time to get approval.

Monkeypox originates from primates in the rainforests of central Africa and is transmitted by contact with bodily fluids from an infected person although human-to-human transmission is rare. Symptoms are similar to those of smallpox, but less severe, and include fever, aches and a rash of pus-filled boils.

The World Health Organization declared monkeypox a Public Health Emergency of International Concern on July 23. Since the outbreak started at the beginning of the year, over 80,000 cases have been reported in more than 100 countries. The first imported monkeypox case was detected on the Chinese mainland on Sept. 16.

Editor: Kim Taylor