SML Genetree Receives FDA Emergency Use Authorization for Ezplex SARS-CoV-2 G Real-Time PCR Kit with Specimen Pooling Capability
SANTA CLARA, Calif., Jan. 14, 2021 /PRNewswire/ -- SML Genetree announced today that it has received Emergency Use Authorization (EUA) from the U.S. FDA for the use of its Ezplex SARS-CoV-2 G Kit, a molecular diagnostic test for the qualitative detection of RNA from SARS-CoV-2 from nasopharyngeal swabs, oropharyngeal swabs and sputum specimens as well as for use in pooled patient specimens containing up to 5 upper respiratory swab specimens. Specimens are to be collected by a healthcare provider using individual vials containing transport media.
Sample pooling is an important public health tool because it allows for more people to be tested quickly using fewer testing resources. Pooled testing is most efficient in areas with low prevalence, meaning most results are expected to be negative. "By providing a pooling protocol, we can assist laboratories in meeting the demand for accurate, high volume molecular test results," said SML Genetree's CEO, Mr. Jihoon Ahn. "We are excited to be able to offer the Ezplex test to the U.S. market."
The Ezplex SARS-CoV-2 G Kit is designed to provide sensitive and accurate results by detecting two different regions of the SARS-CoV-2 virus: the RdRP and N genes. Results are available in approximately 2 ½ hours post RNA extraction. The test is authorized for use in laboratories in the United States certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
For more information on the Ezplex CoV-2 G Assay, visit: www.smlgenetree.com.
About SML Genetree
SML Genetree is recognized as a leading developer of multiplex molecular technologies and multiplex clinical molecular diagnostics in South Korea. SML Genetree is an affiliate of Samkwang Medical Laboratories (SML), one of the largest diagnostic commercial labs in Korea since 1985. SML has continued to provide diagnostic results to customers across 3,000 government medical institutions in Korea, including the Military Manpower Administration (MMA), university hospitals, and local medical institutions. For more information, please visit www.smlgenetree.com.