How MedTech is Rising to Help Combat the Coronavirus Pandemic
Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA.
At the time of writing this blog, the novel coronavirus is rampant in over 150 countries across the world. More than 250,000 cases of infection and over 10,000 deaths have been reported. In the United States, there are currently over 15,000 cases, increasing daily at an exponential rate. Social distancing has become the new normal, and many parts of the country have shelter-in-place orders in effect. Economy is in a downward spiral and stock market is tumbling. Fear, anxiety and uncertainty is everywhere, and no one knows how long this is going to last.
Testing for this new virus, now called the SARS-CoV-2, has been a challenge. As the saying goes, you can’t fight what you can’t see. We are kind of flying blind against this pandemic. In South Korea, aggressive testing helped control the rate of new infections without having to lock down the country and implementing extreme authoritarian measures taken by China. According to a recent Science Magazine article, South Korea tested more than 270,000 people, which amounts to about 5200 tests per million! As a result, the number of new cases in South Korea has now come down to 74 from 909 at its peak on February 29, 2020.
If we were to use that as a target, we would need to do around 1.7 million tests in the United States. However, current estimates show only about 74 tests per million inhabitants have been carried out.
Testing is critical to identify infected individuals, isolate them and contact trace other potentially infected individuals. This allows a rapid, targeted response instead of having to issue a broad, almost country-wide, policy of social distancing.
There is one piece of good news that the FDA has very rapidly approved several tests in the last 2 weeks under the Emergency Use Authorization and more are expected to follow.
The graphic below shows 9 tests approved as of 18 March 2020. Some of these tests are highly sensitive and designed to run on high-throughput diagnostic equipment.
FDA policy issued on 29 February 2020, provided the impetus to the MedTech industry which has risen to the occasion. In this policy, FDA provided clear guidance on test validation including the Limit of Detection, Clinical Evaluation, Inclusivity and Cross-Reactivity. FDA also organized webinars and Town Halls to discuss the policy and answer questions from the industry. The result has been a very rapid development and approval of these tests which can be now deployed in authorized labs across the country.
It is very encouraging to see many of the industry leaders deploying significant resources to this effort. It is not just developing and validating the new test, but also ramping up production capacity. Although estimates of projected test capacity are still evolving, they will likely be in the range of a couple of million tests per week.
Real testing capacity, however, is a function of several factors – number of approved tests, number of authorized labs, availability of reagents and diagnostic equipment, availability of testing personnel, infrastructure for collecting test specimens etc. There has been a significant challenge in all these areas, affecting our ability to quickly ramp up testing across the population.
We still must solve bottlenecks in other parts of the testing chain. Supplies are limited, sample collection sites are still under construction, criteria for who could be tested is evolving, and there is a huge backlog in labs, both public and commercial.
Still, there is hope and expectation that the real testing capacity will ramp up quickly. It takes a collaborative effort across the entire healthcare sector and government agencies at the federal, state and local level. Given the urgency of the situation, and the impact on the economy, there is no doubt that it will be an all hands-on-deck effort.
Until then, we all need to do our part by following the social distancing guidance and keeping each other safe.
References
Science Magazine – Coronavirus cases have dropped sharply in South Korea. What’s the secret to its success?, March 2020
FDA Emergency Use Authorizations, Updated March 2020
FDA Policy Released on 29 Feb 2020, Updated March 2020