Singapore Firm Vela Diagnostics Receives US FDA Emergency Use Authorization and CE-IVD Mark for Zika Detection 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 test, which is developed and manufactured in Singapore, also received the European CE mark for in-vitro diagnostic use in August 2016.

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 Sentosa^® SA ZIKV RT-PCR Test is approved for the identification of Zika virus in patients suspected to suffer from Zika virus infections and it is validated for plasma, serum and urine samples. All three sample types can be processed in the same run, fully automating sample extraction to report output. The Sentosa^® PCR workflow is capable of processing 22 samples per run in under 3 hours.

The molecular test is designed to detect samples with low zika viral load with its detection limit of 3 x 10³ copies/mL for ZIKV PRAVBC59 strain and 6 x 10³ copies/mL for ZIKV MR-766 strain. The molecular test has a high analytical performance with 82 Zika virus strains detected and no cross-reactivity with 44 pathogens including dengue and chikungunya.

"The test is validated with real clinical samples for use with EDTA plasma, serum and urine sample types. If urine is used as the sample type then it must be collected alongside a patient-matched EDTA plasma and or serum specimen. Samples are collected from individuals meeting clinical or epidemiological criteria for Zika virus exposure," stated Dr. Gerd Michel, Chief Scientific Officer of Vela Diagnostics.

Vela Diagnostics will be launching a single multiplex test for Zika virus, Dengue virus and Chikungunya for differentiation amongst the hemorrhagic fevers, which is relevant for an accurate patient treatment with a fast turn-around time.

In response to the recent Zika virus outbreak in Singapore, Vela Diagnostics organized a Zika virus symposium at their headquarters, which was keenly participated by major hospitals and government bodies in Singapore and from the regions, to discuss a holistic approach in diagnosing Zika virus.

Vela Diagnostics' CEO Mr. Michael Tillmann mentioned: " Vela Diagnostics is very concerned over the current Zika Virus situation in Singapore, with the authorization by FDA for emergency use, we aim to provide a fast and highly accurate testing solution to Singapore."

About Vela Diagnostics

Vela Diagnostics provides a broad menu of molecular diagnostic tests, consolidated on its automated Sentosa^® workflow system.  Currently Vela Diagnostics offers 25 CE-IVD approved PCR tests and 5 CE-IVD approved NGS panels validated with 21 different sample types and open-channel capabilities.

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, 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.

Vela Operations Singapore Pte Ltd
(Co Reg No. 201106974H)
50 Science Park Road
#05-07 The Kendall
Singapore 117406
Phone : +65 6672 6060 (Main Line)
Fax : +65 6672 6066
Email: infoAPAC@veladx.com
www.veladx.com