Illumina, Inc (ILMN) announced that it has abided by all the prerequisites of the IVD Directive and has applied for the CE mark for the extended use of the MiSeqDx system in clinical laboratories.
This conformity is a significant turning point for Illumina. It enables ILMN to acquire the permit to commercialize the new role of MiSeqDx, enabled by the MiSeqDx Universal Kit, in a number of European countries. It plans to start shipping the new assay in Europe, effective Nov 2013.
The MiSeqDx Universal Kit comprises library preparation reagents, sample index primers, and sequencing consumables. These are required for laboratories to develop amplicon assays on an in vitro diagnostic platform.
The MiSeqDx is equipped with Illumina's unique sequencing technology, which works on synthesis chemistry. This variant of sequencing technology is widely accepted by genetics researchers worldwide. The device also enables its users to conduct diagnostic or research applications on a single and easy-to-use system.
The latest MiSeqDx Universal Kit is an addition to the existing MiSeqDx Cystic Fibrosis Carrier Screening Assay and the MiSeqDx Cystic Fibrosis Diagnostic Assay. With the introduction of the new MiSeqDx system, clinical laboratories will be able to offer a wider range of diagnostics tests including critical ones for cancer, infectious diseases and genetic disorders.
The MiSeqDx system reflects the keen interest of ILMN to expand its clinical product portfolio through adoption of next-generation sequencing technologies. With this new offering the company intends to provide its clinical customers with great value, coupled with flexibility and reliability.
Currently, ILMN carries a Zacks Rank #3 (Hold).Other medical stocks that are worth a look include Affymetrix Inc. (AFFX), Actelion Ltd. (ALIOF) and Titan Pharmaceuticals Inc. (TTNP), each carrying a Zacks Rank #1 (Strong Buy).