ENZO BIOCHEM RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR TESTING POOLED SAMPLES ON THREE PLATFORMS INCLUDING COMPANY’S GENFLEX™ PROPRIETARY SYSTEM FOR DETECTION OF CORONAVIRUS SARS-CoV-2
Enzo Biochem announced an expansion of its Emergency Use Authorization (EUA) from the FDA for its AMPIPROBE® SARS-Cov-2 Test System. The authorization now includes pooled samples of up to five specimens, significantly enhancing testing capacity amid rising COVID-19 cases. CEO Elazar Rabbani emphasized that this expansion reflects the test's proven accuracy and safety, addressing challenges in access to testing. It positions labs to meet increasing demand for COVID-19 testing services in the coming year.
- Expansion of EUA allows pooled sampling, significantly increasing testing capacity.
- AMPIPROBE® SARS-Cov-2 Test System proven to be accurate and reliable.
- Addresses challenges in COVID-19 testing access; expected demand rise.
- None.
- Use of pooled sampling with Enzo’s molecular diagnostic technology can help rapidly expand the number of people tested for COVID-19 -
NEW YORK, NY, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Enzo Biochem, Inc. (NYSE:ENZ) (“Enzo” or “The Company”), a leading biosciences and diagnostics company, announced today that it has received an expansion of its Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) authorizing the use of pooled samples containing up to five individual swab specimens with the Company’s AMPIPROBE® SARS-Cov-2 Test System utilizing tests on three different platforms including Enzo’s proprietary GENFLEX™ automated high-throughput platform.
“This expansion of the EUA to include pooled samples can rapidly expand testing capacity based on ENZO’s proven, reliable and sensitive PCR-based molecular test for SARS-Cov-2,” said Elazar Rabbani, Ph.D., Enzo CEO. “Access to testing remains a challenge in many states and the introduction of a new and more easily transmissible variant of COVID-19 is likely to increase demand for testing services in the year ahead despite the introduction of multiple vaccines.”
Pooling samples involves qualitative detection of nucleic acid from SARS-CoV-2 in up to five individual upper respiratory swab specimens collected in separate vials containing transport media from individuals that healthcare providers consider to be suspected of COVID-19 infection. Samples can include nasal, mid-turbinate, nasopharyngeal, or oropharyngeal swabs. The now authorized “pooled” approach significantly increases the number of individuals who can be tested with available testing resources.
In its letter of authorization dated December 30, 2020, the FDA stated that the AMPIPROBE® SARS-Cov-2 Test System is authorized under EUA and the “product described in the Scope of Authorization of this letter (Section II) meets the criteria set forth in Section 564(c) of the (Federal, Food, Drug, and Cosmetic) Act concerning safety and potential effectiveness.”
“Expansion of our EUA is another reflection of the proven accuracy and safety in Enzo’s AMPIPROBE® SARS-Cov-2 Test System,” Dr. Rabbani noted. “This option immediately positions labs to expand capacity and meet expected significantly rising demand for testing services for COVID-19.”
About Enzo Biochem
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:
Marisa Monte
Berry & Company Public Relations
212-253-8881
mmonte@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
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