Next-generation sequencer registered in Australia

The Therapeutic Goods Administration (TGA) has informed Illumina that its MiSeqDx instrument for next-generation sequencing has been included on the Australian Register of Therapeutic Goods as a cleared in vitro diagnostic medical device.

Illumina’s MiSeqDx sequencer offers users the ability to perform NGS for in vitro diagnostic or research applications using a single, easy-to-use system. Designed and validated for the clinical market, the instrument harnesses Illumina’s sequencing by synthesis (SBS) chemistry, giving laboratories confidence in their results.

The instrument was the first next-generation sequencing (NGS) system made available for clinical use when it was launched in Europe in 2013. The TGA clearance means it is now available on five continents, with clinical use permitted in the United States, Canada, Argentina, European countries recognising the CE mark, Australia, South Korea, Singapore, Thailand and the Philippines.

“This is an exciting milestone for Illumina and for our clinical customers in Australia,” said Tim Orpin, vice president and general manager for Illumina in the Asia-Pacific region. “We feel strong momentum for clinical NGS in the APAC region, having achieved this regulatory milestone in Australia and the registration of the MiSeqDx sequencer in South Korea earlier this month.”

“The clinical authorisations in South Korea and Australia also accelerate our ability to get other Illumina clinical products into these markets in the future,” added Gretchen Weightman, general manager, South Asia Pacific. “We remain committed to growing these markets by supplying leading NGS products.”