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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.

The Scan

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.