Vela Announces FDA-has cleared Sentosa® SA201 HSV-1/2 PCR Test, a Herpes Simplex Virus Nucleic Acid Amplification Assay
Singapore (February 05,2018) - Vela Diagnostics announced today that its Herpes Simplex Virus Nucleic Acid Amplification Assay, Vela’s Sentosa® SA201 HSV-1/2 PCR Test is now cleared by the U.S. Food and Drug Administration for in vitro diagnostic use. According to the American Sexual Health Association (ASHA), more than 50 percent of American adults have oral herpes, commonly called cold sores or fever blisters, which is almost always due to HSV-1 infection. About one in six people ages 14-49 in the United States have genital HSV-2 infection. However, most people do not know they are infected because their symptoms are too mild to be noticed or are mistaken for something else.
The clearance "marks another significant landmark for Vela in the USA market; it reinforces our overall capabilities in bringing relevant products to global markets, and re-iterates our commitment to providing access to affordable testing solutions on an automated workflow to diagnostic and clinical research customers," Michael Tillmann, Vela Diagnostics CEO says. It is also the second USA FDA milestone for Vela, following the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for the Zika test, known as Vela’s Sentosa® SA ZIKV RT-PCR Test, received in September, 2016.
Vela’s Sentosa® SA201 HSV-1/2 PCR Test is a real-time PCR-based qualitative in vitro diagnostic test for detection and differentiation of Herpes Simplex Virus (HSV-1 and HSV-2) DNA from male and female skin lesions from anogenital or oral sites. The test is intended for use as an aid in diagnosis of herpes infection in symptomatic patients.
This in vitro diagnostic test is validated to be performed on the automated Vela Sentosa® SA201 HSV-1/2 PCR Test workflow. The workflow starts with extraction of nucleic acid from samples (anogenital or oral swabs) using Vela’s Sentosa® SX Virus Total Nucleic Acid Kit on the Sentosa® SX101 instrument. Following extraction, the instrument will automatically set up the PCR with the extracted nucleic acid in a 96-well PCR plate. Subsequently, the 96-well PCR plate is sealed and transferred to the Sentosa® SA201 for PCR amplification, followed by automated data analysis. Vela’s Sentosa® SA201 HSV-1/2 PCR Test contains reagents and enzymes for specific amplification of a 104 bp fragment of UL30 gene common to both HSV1 and HSV2, and specific probes for the direct detection and differentiation of HSV1 and HSV2 amplicons, respectively.
According to the results of the study conducted to determine analytical sensitivity, the Vela’s Sentosa® SA201 HSV-1/2 PCR Test's limit of detection (LoD) is defined as the lowest HSV titer (TCID50/mL) detected with a probability of 95% or greater and was determined to be 40 TCID50/mL for HSV-1 and 4 TCID50/mL for HSV-2. A Reproducibility Study demonstrated the performance of the Vela’s Sentosa® SA201 HSV-1/2 PCR Test using simulated samples (with spiked-in HSV-1/2 virus) across multiple sites, multiple instruments, multiple operators and multiple lots with excellent agreement across the sites, operators, and systems, and the %CV being 5.25% or less across all samples.