Enzo’s Universal AMPICOLLECT™ Used on GENFLEX® Molecular Platform Cleared for Distribution by FDA Under Emergency Use Authorization
Company’s specimen collection kit now available for use in COVID-19 testing in the U.S.
Sample collection kit can be used with PCR based molecular diagnostic or antigen-based testing platforms
NEW YORK, NY, April 21, 2021 (GLOBE NEWSWIRE) -- 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
https://www.enzolifesciences.com/ENZ-GEN228/ampicollect-saline-normal/
Enzo Biochem is a pioneer in molecular diagnostics, leading the convergence of clinical laboratories, life sciences and intellectual property through the development of unique diagnostic platform technologies that provide numerous advantages over previous standards. A global company, Enzo Biochem utilizes cross-functional teams to develop and deploy products, systems and services that meet the ever-changing and rapidly growing needs of health care today and into the future. Underpinning Enzo Biochem’s products and technologies is a broad and deep intellectual property portfolio, with patent coverage across a number of key enabling technologies.
Forward-Looking Statements
Except for historical information, the matters discussed in this release may be considered "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include declarations regarding the intent, belief or current expectations of the Company and its management, including those related to cash flow, gross margins, revenues, and expenses which are dependent on a number of factors outside of the control of the Company including, inter alia, the markets for the Company’s products and services, costs of goods and services, other expenses, government regulations, litigation, and general business conditions. See Risk Factors in the Company’s Form 10-K for the fiscal year ended July 31, 2020. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that could materially affect actual results. The Company disclaims any obligations to update any forward-looking statement as a result of developments occurring after the date of this release.
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Contact:
For Enzo Biochem, Inc.
David Bench, CFO
212-583-0100
dbench@enzo.com
Media:
Holly Stevens
Berry & Company Public Relations
212-253-8881
hstevens@berrypr.com
Investors:
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com
Steve Anreder
Anreder & Company
212-532-3232
Steven.anreder@anreder.com
Released April 21, 2021