Caliper said today that its LabChip Dx instrument, developed in collaboration with Seegene, has obtained CE IVD registration in Europe.
Caliper said that it will now market and sell the product under the European Directive on In Vitro Diagnostic Medical Devices.
LabChip Dx is a modified version of Caliper's LabChip Gx nucleic acid separation platform. In January, Caliper announced that it was partnering with Korea's Seegene to repurpose the platform as a diagnostic tool to analyze PCR products from Seegene's multiplex molecular diagnostic assays (PCR Insider, 1/13/11).
Under the partnership, Seegene is marketing and distributing its Seeplex assays outside of the US for use with the LabChip Dx. The companies also said that they would co-market the products and work together to expand the number of diagnostic tests available and commercialize certain of those assays.
The companies officially launched the LabChip Dx instrument in February, and have since placed 40 of the platforms worldwide, Caliper President and CEO Kevin Hrusovsky said in a statement today.
"Under the CE IVD Mark, the LabChip Dx instrument is available for use with clinical patient samples in Europe, and we expect it will bring significant benefit to European clinical diagnostic laboratories by improving overall lab economics and reducing manual labor requirements," Hrusovsky said. "The CE IVD Mark makes the LabChip Dx more attractive for European diagnostic labs and completes an important regulatory step for running tests from the Seeplex menu of diagnostic assays from Seegene."
The LabChip Dx system features diagnostic identification, scoring, and reporting software; can analyze large numbers of multiplex samples using minimal sample volume; and provides automatic pipetting, thus avoiding the need to further purify or dilute diagnostic PCR products, Caliper said.