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Bio Molecular Systems Gets CE-IVD Mark, Australian Approval for Portable PCR Cycler

NEW YORK — Australian instrument manufacturer Bio Molecular Systems, or BMS, said on Tuesday that its portable MIC qPCR thermo cycler has received CE-IVD marking, as well as approval from Australia's Therapeutic Goods Administration.

The MIC, which is sold by Quantabio as the Q under an OEM agreement with BMS, uses a contactless magnetic induction heating method and a fan for forced-air cooling in order to cycle samples, enabling rapid cycling times. According to BMS, nearly 3,000 of the instruments have been placed for SARS-CoV-2 testing including ones in rural hospitals, airports, and border checkpoints.

In early 2020, Hackensack University Medical Center received Emergency Use Authorization from the US Food and Drug Administration for a molecular SARS-CoV-2 test that uses the MIC instrument.

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