Caliper Announces CE IVD Mark for LabChip® Dx for Clinical Patient Sample Testing |
Caliper Life Sciences, Inc.
68 Elm Street
Hopkinton, MA, 01748
USA
Press release date: July 26, 2011
- Innovative Microfluidics Technology is now Available for Clinical In Vitro Diagnostic Use in Europe -
Hopkinton, MA - Caliper Life Sciences, Inc. (NASDAQ: CALP) announced today that its new, innovative LabChip® Dx instrument has achieved CE IVD registration in Europe. The LabChip Dx, a novel instrument based on Caliper's robust LabChip microfluidics technology, will now be marketed and sold in Europe with the CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices. The LabChip Dx was developed in collaboration with Seegene, Inc., with whom Caliper announced a strategic partnership earlier this year.
"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," said Kevin Hrusovsky, President and CEO of Caliper Life Sciences. "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, launched in February of this year, has seen excellent market uptake," continued Mr. Hrusovsky. "To date, we have received orders for forty units from markets around the world. We believe the robustness and reliability of the LabChip Dx, as well as Caliper's service excellence, have proven to be attractive to our partners and customers."
The LabChip Dx system features diagnostic identification, scoring and reporting software. It is based on the same microfluidics technology that has become the standard electrophoretic separation platform in research, enabling high throughput, multiplexed, cost effective sample processing for discovery and validation of molecular and companion diagnostics. The platform can analyze large numbers of multiplex samples using minimal sample volume, provides automatic pipetting, and avoids the need to further purify or dilute diagnostic PCR products. The cost effective approach of Caliper's robust microfluidics platform explains its high rate of adoption among research laboratories around the world.
About Caliper Life Sciences
Caliper Life Sciences is a premier provider of cutting-edge technologies enabling researchers in the life sciences industry to create life-saving and enhancing medicines and diagnostic tests more quickly and efficiently. Caliper is aggressively innovating new technology to bridge the gap between in vitro assays and in vivo results and then translating those results into cures for human disease. Caliper's portfolio of offerings includes state-of-the-art microfluidics, lab automation & liquid handling, optical imaging technologies, and discovery & development outsourcing solutions.
The LabChip Dx utilizes Caliper's innovative microfluidics technology to perform reproducible, high-resolution, electrophoretic separations for analyzing multiplex PCR products. For additional information about Caliper's solutions for molecular and companion diagnostics, please visit caliperls.com/diagnostics.
Caliper and LabChip are registered trademarks of Caliper Life Sciences, Inc.
Media Contact:
Stacey Holifield/Ben Navon
Schwartz Communications
781.684.0770
caliper@schwartzcomm.com
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