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

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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.

The Scan

New Study Investigates Genomics of Fanconi Anemia Repair Pathway in Cancer

A Rockefeller University team reports in Nature that FA repair deficiency leads to structural variants that can contribute to genomic instability.

Study Reveals Potential Sex-Specific Role for Noncoding RNA in Depression

A long, noncoding RNA called FEDORA appears to be a sex-specific regulator of major depressive disorder, affecting more women, researchers report in Science Advances.

New mRNA Vaccines Offer Hope for Fighting Malaria

A George Washington University-led team has developed mRNA vaccines for malaria that appear to provide protection in mice, as they report in NPJ Vaccines.

Unique Germline Variants Found Among Black Prostate Cancer Patients

Through an exome sequencing study appearing in JCO Precision Oncology, researchers have found unique pathogenic or likely pathogenic variants within a cohort of Black prostate cancer patients.