Enzo Biochem's (ENZ) Universal AMPICOLLECT Used on GENFLEX Molecular Platform Cleared for Distribution by FDA Under Emergency Use Authorization

April 21, 2021 8:09 AM EDT
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Enzo Biochem, Inc. (NYSE: ENZ) (“Enzo” or the “Company”), a leading biosciences and diagnostics company, today announced that the Food and Drug Administration (“FDA”) has cleared its AMPICOLLECT™ Sample Collection kit (manufactured under GMP) for distribution under Emergency Use Authorization. The AMPICOLLECT™ Sample Collection kit is now available for sample collection for COVID-19 testing protocols in the United States.

The Company’s sample collection kit has been shown to meet the FDA’s policy standard as outlined in “Enforcement Policy for Viral Transport Media during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The AMPICOLLECT™ kit is not only authorized for use with Enzo’s proprietary GENFLEX® molecular diagnostic platform, but can also be used for sample collection with other PCR-based molecular diagnostic platforms or antigen-based testing platforms that require the collection of upper respiratory specimens.

Enzo’s sample collection kit represents an integral part of the company’s vertically integrated strategy to develop and deliver one of the industry’s most comprehensive offerings of platforms, products and services to support needs throughout the entire workflow of clinical diagnostic testing. Enzo’s approach has involved the development of specimen collection, sample processing and testing reagents, automated instrumentation for sample preparation and testing, and the validation, scale-up of manufacturing and commercialization of these components.

“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,” said Elazar Rabbani, Ph.D., CEO of Enzo. “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.”

For further information, please visit the FDA’s website and Enzo’s corporate website at:https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-viral-transport-media-during-covid-19


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