Coronavirus Catapults Global Testing Innovation
In a manner of weeks a number of US companies have announced FDA approvals for new testing procedures to be rolled out across the country.
Just 2 days ago, the CDC announced that all 50 states now had drive thru testing centers, allowing worried patients the comfort of not having to leave their car.
A month ago it seemed almost impossible to acquire a Coronavirus test and in the last week we have seen two new testing methods come to market.
Last weekend, California-based molecular diagnostics company Cepheid announced that the FDA had approved their test for hospitals and clinics that would allow for rapid testing, with conclusions available in just 45 minutes.
Hoping to supersede Cepheid’s progress, Brazilian medical tech firm Hi Technologies that manufacturers portable labs has been working to finalize their 15 minute test that could be available around the world in a few weeks. Hi’s founder Marcus Figueredo, wants the tests available around the world by mid-April. The mini testing kits will retail for $25, but will be much cheaper for governments, healthcare providers and non profit organizations according to Figuerdo.
Superseding Hi’s progress, Abbott laboratories received emergency approval from the FDA just yesterday for their new 5 minute Coronavirus test. Abbott announced that “it expects to deliver 50,000 tests per day beginning next week.”
Abbott is utilising technology for the test that is already being used in the testing marketplace, PCR (polymerase chain reaction). The test looks for genes that are also present in the virus. Furthermore, the testing kit is very light, weighing only 6.6 lbs and could be shipped to doctor’s offices around the world. The device will have a negative readout in 13 minutes, but a positive Coronavirus test will only take 5 minutes.
FDA Commissioner Steve Hahn said in a statement, "I am pleased that the FDA authorized Abbott's point-of-care test yesterday. This is big news and will help get more of these tests out in the field rapidly. We know how important it is to get point-of-care tests out in the field quickly. These tests that can give results quickly can be a game changer in diagnosing COVID-19."
Just yesterday, California biotech firm BodySphere announced that their 2 minute Coronavirus test was granted approval. The FDA has "issued Emergency Use Authorization for the test which uses antibodies blood to test for current or past infection. The tests have a 91% clinical specificity rate and a 99% clinical sensitivity rate. " The drawback of this test is that the patient must have carried the virus for several days to be detected by the test. A patient who acquired the virus in the 72 hour period before administration of the test occurs will have their reading come back negative. This is one huge advantage the Abbott test has over the BodySphere test.
Harvard Business Review reported that a number of nonprofits and governmental agencies are looking into making at home testing available for widespread use. A patient could facetime with a doctor who could then authorize the test, which would be mailed to your home.
Perhaps there will be an app eventually for the sole purpose of testing for COVID-19. The technology might not be available today, but with our speed of innovation, it might come sooner than we could imagine.