Caliper's Microfluidic Technologies Enable 510(k) Approved Multiplexed Immunoassay System for Liver Cancer Risk Assessment
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Caliper Life Sciences announced that its licensee Wako Pure Chemical Industries, through its Wako Diagnostics division, has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its uTASWako® i30 Immunoanalyzer and AFP-L3 and DCP Assays, which are used to assess liver cancer risk in patients with chronic liver disease.
The i30 Immunoanalyzer, which incorporates Caliper's microfluidic LabChip® technologies, utilizes microfluidics to integrate sampling, mixing, separation and detection of up to six analytes. The system is currently marketed in Japan by Wako as an in vitro diagnostic (IVD) platform.
Caliper recently announced the LabChip Dx multiplexed reader, which utilizes innovative microfluidics technology to perform reproducible, high-resolution, electrophoretic separations for analyzing multiplex PCR products.
Developed in collaboration with Seegene, the LabChip Dx is based on the same approach that has become the standard, microfluidic based, electrophoretic separation platform in life sciences research, enabling high throughput, multiplex, cost effective sample processing for discovery and validation of molecular and companion diagnostics.
The cost-effective approach of Caliper's robust microfluidics technology explains its high rate of adoption among research laboratories around the world.
