Novel Diagnostics Display Medtech Ingenuity in COVID-19 Fight

COVID-19 has presented unprecedented challenges in infectious disease care and containment, but innovation in diagnostics combined with an increasingly agile FDA is providing one example of how medical technology is an industry that’s ready and willing to rise to the moment.

On Saturday, California-based Cepheid received emergency marketing authorization from the FDA to launch their point-of-care (POC) COVID-19 test. Results are ready within an hour, and this test not only offers speedy results, but broad availability in varied care settings. Rather than directing patients to a hospital or another facility with access to a large, centralized lab, these POC tests can be provided by doctors’ offices, urgent care facilities and other sites, which can in turn reduce the testing burden on already strained hospitals. As HHS Secretary Alex Azar noted in the FDA press release, this POC option can make the tests “much more easily accessible to Americans who need them.” Cepheid, which also produces flu and respiratory virus tests, says they have more than 23,000 platforms installed worldwide, and 5,000 in the U.S. The company says their COVID-19 test will be ready for rollout on March 30.

Cepheid is not the only company with a novel COVID-19 diagnostic authorized for sale by the FDA. Roche received the first such emergency FDA authorization on March 13, enabling labs to perform large volumes of tests on their fully-automated cobas platforms, which are installed worldwide. Thermo Fisher received authorization for their own test a few days later.

Innovation in COVID-19 testing hasn’t been left to the large diagnostic companies. Everlywell and Nurx have advertised plans to bring the test directly to patients by offering home testing options. When the option is launched, patients will be able to request their own tests, perform testing at home, receive results online and consult with a provider through a telehealth option. These kits are not available for sale as of this writing, but we will be watching how the rollout of this new model progresses.

As the U.S. ramps up COVID-19 testing, the diagnostics industry has demonstrated that it is willing and able to support the needs of healthcare facilities, providers and patients. We join all of you in watching this pandemic closely, and we are proud to be part of an industry where innovation and nimble service to unmet needs are keys to its success – and resilience.