According to the latest data from OurWorldinData: "As of July 21, the cumulative number of monkeypox cases in the world reached 15,510; of which Europe accounts for more than 80% of the world, Spain: 3,125, Germany: 2,191, United Kingdom: 2,142, Netherlands: 712, Portugal: 515, Italy: 374, France 1448. There are currently 2,316 people infected with monkeypox in the United States.”
From the trend chart of the daily number of new monkeypox infections counted by OurWorldinData, we can see that the monkeypox epidemic is spreading rapidly, and the growth rate is gradually increasing exponentially.
The first case of monkeypox was detected in the United States on May 18, and the U.S. health department ordered
millions of doses of monkeypox vaccine worth $119 million the next day, with 100 million doses in stock until to June.
On July 15, the U.S. ordered an additional 2.5 million doses of Danish manufacturer Bavarian Nordic A/S's Jynneos vaccine. As for the drug against monkeypox, the U.S. Department of Defense signed a $7.5 million contract with SIGA Technologies on May 12 to purchase oral TPOXX.
On May 19, the FDA approved an intravenous formulation of TPOXX (Tecovirimat) for patients who cannot swallow capsules. The drug was previously approved by the FDA on July 13, 2018, and was the first FDA-approved drug to treat smallpox.
It can be seen that the US government is very vigilant and nervous about monkeypox.
Given the current monkeypox outbreak, the FDA and CDC hope to continue expanding laboratory capacity to deal with more possible cases of infection. On June 29, the FDA stated at the Virtual Town Hall Meeting that the current U.S. public health laboratory and each of the five clinical reference laboratories are capable of conducting 10,000 tests per week.
On July 15, Rochelle Walensky, director of the US CDC, said at a press conference that the US government is gradually expanding the scope of clinical laboratories, and the laboratory can currently test 70,000 samples per week.
At the same time, the FDA worked closely with the CDC to approve new detection reagents. The FDA granted two CDC research and development "Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set" (non-smallpox positive) on June 10 and June 24, respectively. Poxvirus Real-Time PCR Detection Kit) 510(k) approved.
This test developed by the CDC was initially approved by the FDA 510(k) in 2018 for qualitative detection of the DNA of orthopoxviruses other than smallpox, including the DNA of multiple viruses including monkeypox, such as : Vaccinia, Cowpox, and Ectromelia. The FDA-approved test currently cannot distinguish between monkeypox and vaccinia and other orthopoxviruses, and it also cannot detect Variola.
The above is the product description of the only FDA-approved monkeypox detection reagent. The last sentence states that "Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set", this monkeypox PCR reagent can only be used in the laboratory designated by the CDC in the United States.
Since this is a test reagent developed by the US CDC, it is different from the 510(k) approval and information disclosure of commercial test reagents, and its laboratory functional data and clinical data are not disclosed.
Under such circumstances, if an IVD company wants to apply for FDA approval of monkeypox detection reagents (molecules and antigens), it can only do De Novo, or do emergency authorization (EUA) like new coronavirus detection reagents. At present, the FDA has not issued policies and guidelines for emergency authorization. Whether there will be emergency authorization for monkeypox detection reagents depends on the speed of monkeypox spread in the United States and the world and the severity of the disease.
Another method for IVD companies to develop monkeypox detection reagents in the United States is to develop LDT detection reagents through commercial laboratories.
First, the FDA is currently encouraging commercial experiments to test using the only CDC test currently available. The FDA wants commercial labs to use monkeypox-related products, other reagents and automated processes developed by the CDC to increase testing capacity in U.S. laboratories.
Labcorp, the largest commercial laboratory in the U.S., officially announced on July 6 that it has begun using the U.S. CDC’s orthopoxvirus test to detect monkeypox virus, which is capable of detecting all orthopoxviruses other than smallpox. Labcorp is also the first commercial laboratory in the United States to offer monkeypox testing.
Second, the FDA is also currently encouraging commercial laboratories to develop monkeypox detection reagents through the LDT approach. The full name of LDT is laboratory developed test, which is an in vitro diagnostic reagent developed or validated by commercial laboratories. Although FDA approval is not required, there is a standard application process and regulations, and after development it can only be used in the applying laboratory.
Of course, our company is trying to apply for LDT approach and we have got Europeen CE certificate for Monkeypox virus antibody IgG IGM Rapid Test Device and Monkeypox virus antigen rapid test device. If Customers that need to know more about the supply of monkeypox antibody&antigen rapid test device, please feel free to contact us.