The COVID-19 pandemic has demonstrated the urgent need for decentralized, low-cost, rapid point-of-care testing, leading manufacturers to sharpy increasing production of COVID-19 antigen tests. A new analysis by NPR and the Harvard Global Health Institute shows the U.S. will need to conduct 14 million COVID-19 rapid tests per day to effectively fight the spread of the virus. That’s more than 5 billion tests per year. Similarly, epidemiology professor Michael Mina has called for rapid testing of every American every day.
For perspective, before COVID-19, the lateral flow testing industry only produced a total of 2-3 billion tests per year for ALL use cases combined (malaria, HIV, home pregnancy tests, etc.).
To meet demand, manufacturers of recently approved antigen tests such as Abbott Laboratories, Becton, Dickinson and Quidel are scaling up at an unprecedented rate, each aiming to make 40-80 million tests per month by the end of the year.
This dramatic scale-up has put the spotlight on our client BioDot, which manufactures automated, ultra-low volume dispensing platforms that are currently used by 70+ diagnostics manufacturers to produce COVID-19 tests. Just one of BioDot’s systems can support the production of some 100 million COVID-19 tests per year.
CEO Anthony Lemmo recently spoke with Reuters and shared that he has received orders that would translate into roughly 500 million tests in the coming months. Despite this, current demand outstrips current supply, and this will only increase if at-home testing of asymptomatic patients receives regulatory approval. Yet, no company has been cleared to sell tests directly to consumers and the FDA continues to evaluate how results from antigen tests will be publicly reported to public health officials. As Mr. Lemmo recently shared with USA Today, “To just go to CVS and buy it without this information being collected, from an epidemiological point of view, feels like a big hole.”
Even after a vaccine is developed, testing will be critical to know how effective a vaccine is or will be. “The world now knows that diagnostics matter,” Mr. Lemmo told the Orange County Business Journal. As such, the diagnostics industry must continue to adapt and scale. In this piece in 360Dx, Mr. Lemmo predicts that in the first quarter of 2021 the industry will have ten times the testing capacity of what is available right now.