The U.S. Department of Health and Human Services has declared a public health emergency in the U.S. over the coronavirus in part because a government diagnostic for the virus yields inconsistent results, a fact that may spur the life sciences to provide a solution.

The World Health Organization (WHO) had initially declined to act on the spread of the latest mutation of the coronavirus, dubbed 2019-nCov by virologists. WHO reversed that decision Jan. 30, however, emphasizing the need for therapies and diagnostics to combat the pathogen, which at that point was traced largely or entirely to Wuhan, the provincial capital of China’s Hubei province.

On-again/off-again positive test results

Robert Redfield, director of the U.S. CDC, said in a Jan. 31 briefing that the CDC test had demonstrated considerable variability in performance. More than one patient has tested positive, only to test negative for the virus a day or two later. However, the virus was detectable yet again three days later.

Anthony Fauci, director of the National Institute for Allergy and Infectious Disease (NIAID) at the National Institutes of Health, said the oscillating outcomes in the testing creates tremendous uncertainty. “We don’t know the accuracy of this test,” he said, adding that test for the human immunodeficiency virus is nearly 100% accurate. “That’s not even near what we have right now” for the coronavirus, he said.

Redfield said that while the situation in China is serious, the risk to the American public is low. “Our goal is to do all we can do to keep it that way,” he said, adding that there were nearly 9,700 diagnoses in China as of that date, with more than 200 deaths. However, the global count included confirmed diagnoses in 12 individuals who had not traveled to China.

In a Feb. 3 update, CDC said it has 11 confirmed diagnoses in the U.S., with 82 pending tests. The confirmed cases in the U.S. were seen in California, Washington, Arizona, Illinois and Massachusetts. Globally, confirmed cases have been cited for Canada, Russia, Australia, India and a number of European nations, including France, Germany and the U.K.

CDC has launched an aggressive response, Redfield said, focusing on early case recognition, isolation of the identified cases, and tracing of those with whom the identified cases came into contact. “This response is a layered response” with targeted airport screening and public health education with a focus on those who have traveled to China, he said. “I want to emphasize that this is a significant global situation, and it continues to evolve,” Redfield said.

Fauci said there have been about 8,000 deaths in the U.S. and roughly 100,000 hospitalizations attributable to influenza in the current influenza season. He said he and other government officials are often asked why there is so much emphasis on the latest mutation to the coronavirus and relatively little on influenza.

Trajectory of influenza much more predictable

“The reason is that despite the morbidity and mortality with influenza, there is a certainty” as to the trajectory of the influenza outbreak. “As we get into March and April, the flu cases are going to go down. You can predict pretty accurately what the range of the mortality is and the hospitalizations,” he said, adding that this kind of predictability is lacking with the coronavirus outbreak. “The number of cases has steeply inclined each and every day.”

Secretary of Health and Human Services Alex Azar said, “We continue to operationalize a multilayered, cross-agency public health response.” Any U.S. citizen returning from abroad who has been in the Hubei province in the previous 14 days will be subjected to a 14-day quarantine to ensure proper care and screening. “This applies only to U.S. citizens who have been in Hubei province,” Azar emphasized, but he said that any U.S. citizen that was in any other region in China within the prior 14 days will undergo screening at a select number of ports of entry and 14 days of monitored self-quarantine.

The White House had declared that it would suspend entry of foreign nationals seen as posing a risk of transmitting the virus, and Azar said these policies went into force at 5:00 p.m. U.S. Eastern time, Sunday Feb. 2. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said Feb. 3 that the agency is expediting the release of the test to non-CDC sites. Messonnier said the CDC and the FDA have been working closely since deciding that the emergency use authorization (EUA) mechanism is the most expeditious means for disseminating the CDC test.

Gottlieb pushes for quicker response

Former FDA commissioner Scott Gottlieb took to Twitter Feb. 3, stating, “we need to have a posture where we are going to try to detect outbreaks early,” which suggests broader screening criteria and increased capacity for such screening. Gottlieb said the posture of the U.S. federal government seemed to be to prevent the introduction of the virus to the U.S., but that this is an accomplished fact. Ergo, he said, CDC should broaden the distribution of its test to other labs.

“It’s a simple PCR test, a lot of people could run it,” Gottlieb said of the CDC polymerase chain reaction diagnostic. Anyone with symptoms of viral pneumonia and a negative result for viral pneumonia should be screened “even if they haven’t been to China,” Gottlieb said, assuming “it’s a suspicious case.” The coronavirus is now into a secondary spread phase. He said that anyone with the coronavirus who develops pneumonia might represent as little as 10% of the actual cases, and relatively few of these will land in a hospital. Thus, he said, “you want to get that trigger [for testing] earlier so you can spot small outbreaks earlier” and thus “prevent them from becoming big outbreaks.” Gottlieb also said the next two to three weeks will be critical to efforts to corral the virus in the U.S.

In an investor’s note, analysts at Wells Fargo Securities LLC, of San Francisco, said a number of medical device and diagnostics companies have some exposure to the circumstances in China. The analysts, including lead analyst Larry Biegelsen, said the circumstances are reminiscent of the 2009 H1N1 outbreak and the 2002-2003 outbreak of severe, acute respiratory syndrome (SARS), adding that China accounts for only 5% to 10% of revenues for most large-cap med-tech firms.

The Wells Fargo note indicated that most companies still see the situation in China as too fluid to predict the eventual impact, most of the large-cap companies see the likely impact as short of material to financial concerns. However, the U.S. International Trade Commission indicated in a January 2018 analysis that diagnostic devices and equipment exported from China reached $1.4 billion in 2016. That same year, orthopedic implants shipped from China had reached $555 million.

Makers of pharmaceuticals might face a more difficult predicament if their products are based on active pharmaceutical ingredients (APIs) made in China. Many such facilities are located in Zhejiang province, which is located several hundred miles from Hebei province. The Council on Foreign Relations estimated last year that as much as 80% of APIs that become finished products in the U.S. come from China. Still, China’s government plans to enroll a study of remdesivir, a treatment for Ebola by Gilead Sciences Inc., of Foster City, Calif.

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