25 Jun Ramping up COVID-19 Testing. Click to Keep Reading…
Most people have been very frustrated with the amount of time it has taken to implement widespread COVID-19 testing. The world was certainly not ready for the number of people that needed to be tested because of the pandemic. I partner with multiple medical device companies in the Boston area, and they have been working non-stop to supply vast quantities of test kits. This has been a combination of improving the supply chain and also changing the technology used for testing.
Obviously, the strain that was put on the global supply chain to obtain testing materials was unprecedented. For example, the largest supplier of nasal swabs was in Italy. To help with the domestic needs, additive manufacturing companies started printing swabs until the suppliers were able to catch up with demand. The swabs have also been redesigned and tooled in multiple locations. Hopefully, the new ones are a little less invasive as well.
The next challenge was the instruments that could test the nasal swab sample for COVID-19. Test kits had to be developed so current instruments could test for the virus. The biggest problem was the time it took to run the tests. Typically, it’s a process that could take days or weeks, but having results in hours is critical to a positive outcome for patients. Abbott Labs has a flu testing device (ID NOW) that received FDA approval for COVID-19. This point of care product is able to obtain test results in 13 minutes and is being used at many of the CVS testing locations. They have shipped about 1.7 million tests so far.
Another product that has received significant attention is Panther Fusion, a Hologic product. They developed an assay for COVID to be run on the Panther in under 8 weeks. Being able to run about 1,000 tests in 24 hours, it fills the void for higher throughput of tests. They obtain results in about three hours. Hologic is hoping to ramp up manufacturing of test kits to around 1 million a week by July 1.
These are just two examples of test kits out of the 50+ kits approved by the FDA in the last two months. The ramp up has included large companies like Hologic, Abbott, Thermofisher, Roche, Perkin Elmer, and dozens of start up companies with approved equipment. Many more companies are developing new technologies that are going to continue to improve lead time and accuracy. In addition to test kits for the virus, many of these same companies have developed products for antibody testing to determine if you have had COVID-19 (and may not have had symptoms).
I’m hoping that all these companies can continue to do great things with the technology and supply chain, so that we can get our lives back to normal.–Commentary provided by Chris Dunham