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Dx Focus Sep 8, 2011: Clinical and Regulatory PCR and Nucleic Acid Testing News


Qiagen said this week that it has signed an agreement with Eli Lilly to develop a companion diagnostic for an early-stage compound that Lilly is developing to treat blood cancer.

Specifically, Qiagen will develop an assay for the JAK2 V617F mutation that will identify patients likely to respond to the Lilly compound, which targets the Janus kinase 2 gene that has been shown to play a role in myeloproliferative neoplasms.

The PCR-based companion diagnostic will run on the Qiagen's Rotor-Gene Q instrument and the company will have exclusive marketing rights to the test. Qiagen said it plans to seek regulatory approval for full automation of the assay on its QIAsymphony RGQ platform.

Qiagen gained exclusive access to the JAK2 biomarker through an agreement with Ipsogen, which it is currently in the process of acquiring.

Luminex subsidiary EraGen Biosciences has received 510(k) clearance from the US Food and Drug Administration for the use of BioMérieux's NucliSens easyMag extraction system with its MultiCode -RTx HSV 1&2 Kit.

EraGen said that the new approval allows labs to use either the Roche MagNA Pure or the BioMérieux easyMAG extraction system as part of their testing workflows, thereby expanding the availability of the test to labs that don’t have the MagNA Pure system.

EraGen said that its MultiCode-RTx HSV 1&2 Test provides PCR-based qualitative testing and typing of HSV-1 & HSV-2 in approximately four hours.