NEW YORK – Enzo Biochem said on Wednesday that the US Food and Drug Administration has granted Emergency Use Authorization to the company's Ampicollect Sample Collection kit, making it available for COVID-19 testing protocols in the US.
The kit has been shown to meet the FDA's standards during the pandemic for viral transport media, Enzo said. It can be used with Enzo's GenFlex molecular diagnostic platform as well as other PCR-based molecular diagnostic or antigen-based testing platforms that require the collection of upper respiratory specimens.
"Emergency Use Authorization for our Ampicollect Sample Collection kit is another reflection of the strength of our open platform approach and integrated model at work," Enzo CEO Elazar Rabbani said in a statement. "By internally developing and manufacturing key aspects of diagnostic testing technologies, we have successfully overcome the systemic challenges that affected this sector during the COVID-19 pandemic, including supply shortages and high costs."