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November 22, 2021

Vela Diagnostics announces new automation options for ViroKey test

The EUA permits the use of the Hamilton Microlab STAR test option, which has a throughput of 376 samples in one run.

Vela Diagnostics has announced expanded automation for its ViroKey SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) Test v2.0, which can now be used with the Hamilton Microlab STAR platforms and KingFisher FLEX system.

The US Food and Drug Administration (FDA) granted emergency use authorisation (EUA) to the test.

Now operating with the KingFisher FLEX, the test will have a lower turnaround time and boosted sample throughput while preserving the SA201 Reporter of the company and offering clinically significant reports to pathologists.

Vela also provides the Hamilton Microlab STAR test option, which possesses a throughput of 376 samples in one run.

The company noted that the PCR is still being carried out on the Sentosa SA201 and, in combination with the SA201 Reporter, offers quick and precise reporting.

Vela Diagnostics executive vice-president Steven Wallace said: “The Hamilton Microlab STAR workflow option comes at a time when many of our customers are still ramping up Covid-19 testing.

“This high-throughput workflow will allow laboratories to process substantially more samples per day, with less hands-on time and reduced labour cost.”

The company presented the workflow test data for the two new options to the FDA and it has been accepted as an addition to the test’s EUA.

The FDA has not yet examined the updated test data of ViroKey SARS-CoV-2 RT-PCR Test v2.0, but the product revisions are under review.

Commercial availability of the test’s new options in US markets is granted under the EUA distribution policies of the FDA.

The new workflows of the company complement its currently available sample-to-result solutions, such as the next-generation sequencing (NGS) workflow utilised for the Sentosa SQ HIV-1 Genotyping Assay (IVD) on the Sentosa SQ301.

In March, the company announced the addition of ViroKey SQ FLEX SARS-CoV-2 Genotyping Assay and ViroKey SARS-CoV-2 ID RT-PCR Test to its portfolio offering for Covid-19 testing.

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