Vela Diagnostics Gets FDA Emergency U.S. Authorization for Zika Test
SINGAPORE, Sept. 26, 2016 /PRNewswire/ -- Vela Diagnostics announced today that the Sentosa® SA ZIKV RT-PCR Test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration.
The real-time PCR test by Vela Diagnostics enables the qualitative detection of RNA from Zika virus in human specimens and is available for use in laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. S263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
The test is authorized for use with serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria and/or epidemiological criteria.
Authorized to run on the automated Sentosa® SX101 real-time PCR workflow, along with the Sentosa® SX Virus Total Nucleic Acid Kit v2.0, authorized laboratories can process 22 samples per run for rapid detection of Zika virus with a turn-around time of approximately 3 hours.
- This test has not been FDA cleared or approved;
- This test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. S360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Vela Diagnostics
Vela Diagnostics provides a broad menu of molecular diagnostic tests, consolidated on its automated Sentosa® workflow system. The company was founded in 2011 with the vision of providing in vitro diagnostic solutions for customers to achieve improved patient management. Vela is a privately owned Group of Companies headquartered in Singapore. The Asia Pacific, European, Australian and North American commercial operations of the Group are based in Singapore. The Asia Pacific, European, Australian and North American commercial operations of the Group are based in Singapore, Hamburg, Sydney and New Jersey, respectively. Vela Diagnostics also operates Global R&D and Global Manufacturing facilities in Singapore. For more information, please visit us at www.veladx.com
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SOURCE Vela Diagnostics