The U.S. Food stuff and Drug Administration has issued an crisis use authorization for a Birmingham company’s COVID-19 exam.
BioGX’s Xfree COVID-19 check is described as a very simple-to-use, total freeze-dried take a look at in a solitary tube.
To conduct the Xfree RT-PCR exam, the user rehydrates the take a look at with molecular grade drinking water, provides a patient sample, and operates the examination on a validated actual-time PCR instrument. The take a look at can be delivered any place in the environment without refrigeration, according to the firm.
The Food and drug administration has authorized the test with broad specimen protection, and with extracted samples providing solutions that adapt the check in any workflow. BioGX suggests it is by now in use in many laboratories.
The check expenditures concerning $7 and 12 for every sample, based on its use. BioGX CEO Shazi Iqbal said the exam delivers “robust strain coverage” for all widespread strains, which include the Delta variant of COVID-19. It also delivers a route ahead for other products and solutions.
“The Food and drug administration authorization of our Xfree chemistry paves the way for us to leverage our expansive menu of assessments to create an Xfree line of stage-of-treatment assessments for respiratory and urinary tract infections”, he additional.
Earlier this 12 months, BioGX announced a shift out of Innovation Depot to a Valleydale Street place in Shelby County, investing about $5 million in the place.