Wako i30 Immunoanalyzer incorporating Caliper's microfluidic LabChip technologies receives 510(k) clearance

Caliper Life Sciences, Inc. (Nasdaq: CALP) today 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.

"Wako was an early adopter of Caliper's microfluidic LabChip technology and the 510(k) approval for the uTASWako i30 Immunoanalyzer instrument and associated diagnostic tests is an important milestone in the validation of microfluidics as a valuable platform for diagnostics," said Kevin Hrusovsky, President and CEO of Caliper Life Sciences.  "Caliper's microfluidic technologies are playing an increasing role in diagnostics through our licensees such as Wako, Becton Dickinson, Canon, as well as through Caliper's own direct channel.  Partnerships, like the recently announced Sony DADC collaboration, have uniquely positioned Caliper to develop breakthrough diagnostic solutions based on high volume plastic consumable manufacturing capabilities."

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.  

Source:

Caliper Life Sciences, Inc.

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