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Vela Diagnostics HSV Test Gets FDA Clearance

This article has been corrected to note that Vela has completed a pre-submission process for an HIV drug resistance test but has not yet filed an application for marketing clearance.

NEW YORK (GenomeWeb) – The US Food and Drug Administration has cleared a herpes simplex virus (HSV) assay from Vela Diagnostics, the firm announced today.

The Sentosa SA201 HSV-1/2 PCR test detects viral DNA from oral or anal skin lesions in symptomatic patients. Following nucleic acid extraction using the Sentosa SX Virus Total Nucleic Acid Kit, the test runs on 96-well plates on the firm's Sentosa SX101 instrument, with subsequent automated data analysis.

The clearance marks a significant landmark for Vela in the US market, said Michael Tillmann, Vela Diagnostics CEO. "It reinforces our overall capabilities in bringing relevant products to global markets, and reiterates our commitment to providing access to affordable testing solutions on an automated workflow to diagnostic and clinical research customers," he noted in a statement.

The test is the second from Vela to achieve US regulatory clearance, the firm said. An assay for Zika virus was granted Emergency Use Authorization in 2016.

In addition to infectious diseases, Vela is also building out virology and oncology menus. Last year, the company got CE mark for a hepatitis B virus assay, approval in Singapore for an HIV genotyping test, and completed a US FDA pre-submission process for a test that determines drug resistance of HIV. It also recently licensed technology for enriching rare sequences, received CE-IVD marking for a kit to recover cell-free DNA, and obtained regulatory clearance in Singapore for a next-generation sequencing-based melanoma panel.