NEW YORK – Qiagen said Tuesday that its QiAcuityDx digital PCR system has been included in the Australian Register of Therapeutic Goods regulatory mechanism.
The inclusion enables the system to be used clinically in Australia and New Zealand. The instrument and consumables are also IVDR-certified.
The QiAcuityDx is a five-channel platform that integrates partitioning, thermal cycling, and imaging in a single instrument, processing up to four nanoplates simultaneously. It produces results in approximately two hours, with an IVD mode offering validated assay plug-ins and automated analysis, and a utility mode allowing labs to run laboratory-developed tests and research applications. It also provides a bidirectional LIMS interface for integration with electronic patient records.
"QiAcuityDx allows our users in infectious diseases and clinical oncology to have access to an all-in-one digital PCR system that uses consumables that comply with strict regulatory standards," said Piers Murray, Qiagen's head of sales for Australia and New Zealand, in a statement. "Our goal is to give regional laboratories the flexibility to monitor cancer patients locally."
The platform supports a range of research-use assays. Qiagen also said it plans to launch oncohematology assays on the system, beginning with a BCR::ABL test next year. In addition, the firm has partnered with pharmaceutical companies to develop companion diagnostics on QiAcuityDx and said that future assay development will include collaborations with third parties creating their own tests for the platform.