Seegene has completed the FDA registration of its nucleic acid extraction instrument, the Seegene STARlet and will begin offering the clinical instrument and Universal Extraction Cartridge Kits in the US.


Image: Seegene completes FDA registration of nucleic acid extraction instrument. Photo: Courtesy of Darwin Laganzon/Pixabay.

Seegene’s extensive experience and long-standing success as a molecular diagnostic syndromic multiplex assay and instrument system provider to over 1,000 laboratory networks in 57 countries has resulted in an automated sample processing solution capable of simultaneous handling of a wide variety of sample types using an innovative Universal Extraction Cartridge Kit system. With a throughput of processing 94 samples in about two hours, the system can easily accommodate small laboratories with many different sample types that need to be processed quickly to large laboratories with large batch processing needs.

Utilizing the well-established liquid handler instrumentation and precision technologies developed by Hamilton Company and modified under contract for Seegene and combining that with the proprietary chemistries provided in Seegene’s Universal Extraction Cartridge Kit, the Seegene STARlet system allows superior nucleic acid recovery from such diverse sample and tube/vial types as swabs, aspirates, sputum/bronchoalveolar lavage fluids, whole blood, stool, urine and liquid based cytology samples. Whether targeting bacterial, viral, parasitic, fungal or mammalian genomic DNA or RNA, Seegene STARlet system has been extensively tested in the global market.

From its intuitive user interface software to barcode reading and LIS connectivity capabilities for full sample traceability, the Seegene STARlet system provides an efficient, reliable and affordable workflow solution for all U.S. laboratories. Seegene Technologies, the U.S. subsidiary of Seegene Inc. located in Walnut Creek, California, will lead the U.S. sales and marketing efforts.

Currently, the nucleic acid extraction with transfer functions and the Universal Extraction Cartridge System are FDA registered. Seegene is preparing to get additional functions including PCR setup and de-capping and re-capping of liquid based cytology vials FDA registered by the end of 2019.

Source: Company Press Release