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Qiagen Expands CDx Deal with Tokai; Acquires CTC Assets from AdnaGen

NEW YORK (GenomeWeb) – Qiagen and Tokai Pharmaceuticals are expanding their existing agreement to develop and commercialize a companion diagnostic for galeterone, Tokai's late-stage investigational drug for castration-resistant prostate cancer.

As part of their latest deal, Tokai said it will receive exclusive rights from Qiagen to the CTC enrichment technology it has acquired from AdnaGen, so that the technology may be incorporated into the companion diagnostic Qiagen is already developing for galeterone. In a process called immunomagnetic cell enrichment, AdnaGen's technology uses magnetic particles to enrich tumor cells in an antibody mixture; then it isolates and purifies messenger RNA via RT-PCR.

The US Food and Drug Administration has granted galeterone fast track status, and the investigational agent is slated to enter Phase III studies in the first half of this year. In the 148-patient Phase III ARMOR3-SV trial, researchers are planning to use Qiagen's assay to measure AR-V7 expression in patients' CTCs. The test will run on Qiagen's Rotor-Gene Q MDx detection platform, Qiagen said.

In February, researchers from Johns Hopkins University presented data at a medical conference suggesting that expression of AR-V7 — a truncated form of the androgen receptor — in CTCs may be a potential marker for guiding therapy choice in metastatic castration-resistant prostate cancer patients. Specifically, their analysis revealed that men who were AR-V7 positive did markedly better on chemotherapy than with hormone treatment, while AR-V7-negative patients experienced similar efficacy from either treatment. JHU researchers used the CTC detection method developed by AdnaGen for their study.

Another prospective JHU study and a retrospective analysis by MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center has shown that patients with C-terminal loss and AR-V7 are poor responders to castration-resistant prostate cancer drugs Janssen Biotech's Zytiga (abiraterone acetate) and Astellas' Xtandi (enzalutamide). 

Acquiring AdnaGen's CTC detection technology "adds important new capabilities to our leadership position in liquid biopsy-based molecular diagnostics," Qiagen CEO Peer Schatz said in a statement.

Qiagen in January said it had received a CE-IVD mark for its therascreen EGFR RGQ Plasma PCR kit, a liquid biopsy companion diagnostic co-developed with AstraZeneca to help physicians determine whether advanced non-small cell lung cancer patients are likely to benefit from the EGFR inhibitor Iressa (gefitinib) when sufficient tumor tissue isn't available.

Qiagen Manchester will develop the CTC test for Tokai. Qiagen said in a statement that it has also acquired technologies and other assets from Alere subsidiary AdnaGen, such as AdnaTest BreastCancer and AdnaTest Prostate Cancer. The tests are CE-IVD marked and sold in Europe.