Seegene, Seoul, South Korea, a developer of multiplex polymerase chain reaction (PCR) technologies, has completed FDA registration of its nucleic acid extraction instrument, the Seegene Starlet. The company will begin offering the clinical instrument and its universal extraction cartridge kits in the United States.
The Seegene Starlet system allows nucleic acid recovery from such diverse sample and tube types as aspirates, liquid-based cytology, sputum/bronchoalveolar lavage fluids, stool, swabs, urine, and whole blood. The system has been extensively tested around the world for targeting bacterial, fungal, mammalian, parasitic, or viral genomic DNA or RNA.
The extraction cartridge kits handle a wide variety of sample types at a throughput of 94 samples in approximately 2 hours. Such processing speed allows the system to accommodate the needs of both small laboratories with many different sample types requiring rapid processing and large labs that process large batches.
The Seegene Starlet system incorporates intuitive user software, barcode reading capability, and laboratory information system connectivity for full sample traceability.
Seegene’s molecular diagnostic instrument system and multiplex syndromic assay using the extraction kit are in use in more than 1,000 laboratory networks in 57 countries. Sales and marketing of the system in the United States will be handled through the company’s subsidiary, Seegene Technologies, Walnut Creek, Calif.
FDA registration for additional system functions such as PCR setup and decapping and recapping of liquid-based cytology vials is expected by the end of 2019. For more information, visit Seegene.