Vela HIV, Melanoma Assays Secure Regulatory Approvals

NEW YORK (GenomeWeb) – Vela Diagnostics announced today that it has received regulatory approval for its Sentosa SQ HIV genotyping assay in Australia and its Sentosa SQ melanoma panel in Singapore.

The HIV assay runs on the company’s SQ301 next-generation sequencing platform and is designed to detect HIV-1 Group M genomic mutations in protease, reverse transcriptase, and integrase regions from plasma in patients diagnosed with HIV infection. Now approved for diagnostic use by the Australian Therapeutic Goods Administration (TGA), the test is also awaiting CE-IVD marking and is being reviewed by Singapore regulators.

The melanoma panel is a next-generation sequencing-based test that screens for 127 hotspot mutations and runs on a customized Thermo Fisher Scientific Ion Torrent PGM system. It is now approved for in vitro diagnostic use by the Singapore Health Sciences Authority, and received CE-IVD status in 2014 and TGA approval in 2015.

Vela has received approvals for a number of its diagnostic assays recently, including its Sentosa SA HBV quantitative PCR test, which received CE-IVD approval in April; and its Sentosa SA ZIKV RT-PCR test, which received CE marking about a year ago.

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