The regulators nod means that laboratories that run relatively lesser tests on a day to day basis may also be able to conduct the complete blood count (CBC) test with just two drops of blood.
“This could be a big change because at the moment a traditional analyzer can be placed in laboratories that run thousands of tests every week,” said Sarah Levy, chief technical officer at Sight Diagnostics.
CBC is a blood test that gives a snapshot of ones overall health and can also used to detect leukemia. The FDA clearance could bring down costs at laboratories with lower volumes, as traditional CBC tests which use a technology known as flow cytometry, normally require dedicated personnel to maintain the device, adding to costs.
Exhibitor Data Sheet