The FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug CHLOROQUINE, which is already approved for treating malaria, lupus and rheumatoid arthritis, to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy of using chloroquine to treat COVID-19.
The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort. With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them.
With the development of point of care diagnostics, Americans who need tests will be able to get results faster than ever before. More and more options for reliable, convenient testing are becoming available at an incredibly rapid pace, thanks to the hard work of our FDA team and the ingenuity of the American industry.
Today marks an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.
We believe the actual number of 2019-nCoV cases in mainland China is likely much higher than that reported to date. Specifically, we estimate there to be around 58,000 cumulative cases of 2019-nCoV in mainland China by the end of January (as of January 31, the reported cases are close to 12,000). This estimate is in line with our previous analysis on January 25, which estimated the proportion of reported to estimated cases to be close to 10%.
It is likely that part of this discrepancy is due to reporting delays. However, the substantially larger number of estimated cases suggest a majority of the cases may be mild (or asymptomatic), do not require seeking medical care, and thus are not reported. Furthermore, based on this analysis, we believe the outbreak began in November, and there were already hundreds of human cases of 2019-nCoV in Wuhan in early December. The estimated verses confirmed cases during January are presented below.
There were 181 confirmed cases with identifiable exposure and symptom onset windows to estimate the incubation period of COVID-19. The median incubation period was estimated to be 5.1 days, and 97.5% of those who develop symptoms will do so within 11.5 days of infection. These estimates imply that, under conservative assumptions, 1% (1 in 100) of infected cases will develop symptoms after 14 days of active monitoring or quarantine.