We projected in Kalorama’s mPOC market study that molecular point of care ( mPOC ) would lead the fight in meeting the demand for COVID-19 testing with accurate and fast results. Lab staff is at a premium, hospitals are taxed, and testing needs to happen where it can be useful to isolate patients. We suggested that Cepheid was a likely candidate for an early EUA, and that has turned out to be the case. This was based on the company’s track record with Zika and Ebola, as well as a host of other diseases where it has been a first-mover on rapid molecular tests.
As we suggested might happen and as the company predicted, Cepheid has designed a cartridge that uses the existing platform which will save at least 23,000 locations [5,000 US] from having to buy a new instrument. They company says it will start shipping on March 27th.
Danaher’s Cepheid on Saturday said it has received emergency authorization from the U.S. Food and Drug Administration to use its rapid molecular test for point-of-care patients that can detect the virus that causes COVID-19 in 45 minutes.
We suggested that Cepheid was a likely candidate for an early EUA, and that has turned out to be the case. Also, as we suggested, the company has designed a cartridge that uses the existing platform which will save at least 23,000 locations from having to buy a new instrument.
Cepheid said the following in a statement: “During this time of increased demand for hospital services, clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities. An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on health-care facilities that need to properly allocate their respiratory isolation resources,” said Dr. David Persing, MD, Ph.D., chief medical and technology officer at Cepheid.
Other near-patient systems are Credo Biosystems, based in Singapore, which received a CE-Mark for its test, and GenMark’s near-patient e-Plex COVID-19 test, which received an EUA this week.
But Cepheid’s new test is a significant development, for the following reasons:
- Cepheid has a greater installed base than other systems, and a design that fosters easier use in a clinical setting.
- The announced speed of 45 minutes is much faster than any approved test we have read of so far, several magnitudes higher than the speed of the approved tests of last week.
- It requires no operator training to take the test and determine a result. This means it can be used in a doctor’s office or retail clinic.
- 45 minutes is a brief enough time to await results at point-of-care under normal circumstances.
- Also extraction steps using a kit are not necessary, this is handled in the machine. There is currently backlogs with such kits at major manufacturers.
- They are not high-throughput systems, so a test like say a Cobas 6600 in a lab can produce many more test results in a shift, but they are faster so volume is not insignificant.
If one is looking for an example of how fast the IVD industry that Kalorama has observed for two decades can respond to a crisis, this – along with approvals announced by Roche, Abbott, and other firms of mod-complex systems – is evidence.