Enzo Biochem, Farmingdale, NY, has received FDA emergency use authorization (EUA) for 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,” says Elazar Rabbani, PhD, 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,” Rabbani notes. “This option immediately positions labs to expand capacity and meet expected significantly rising demand for testing services for COVID-19.”
For more information, visit Enzo Biochem.