Qiagen, a Netherlands-based holding company, has partnered with Germany-based Tokai Pharmaceuticals to combine new circulating tumor cells (CTCs) technology with a molecular assay to co-develop and commercialize a companion diagnostic for Tokai's novel drug compound galeterone, which is in late-stage clinical trials for treatment of castration-resistant prostate cancer (CRPC). The non-invasive test will determine the expression of the AR-V7 biomarker, which in recent studies demonstrated potential utility to guide therapy choice in CRPC patients.

"The innovative CTC detection method, developed by the AdnaGen team and utilized as part of a novel diagnostic approach by thought leaders at Johns Hopkins University, adds important new capabilities to our leadership position in liquid biopsy-based molecular diagnostics. Our partnership with Tokai Pharmaceuticals, one of the collaborations which we are pursuing with pharma in this area, is expected to result in such a liquid biopsy, CTC-based companion diagnostic, with potential to enhance outcomes for prostate cancer patients," said Peer M. Schatz, CEO of Qiagen.

"Following the success of the first-ever regulated companion diagnostic for solid tumors based on molecular biomarkers from a liquid biopsy in Europe, we are expanding our portfolio of highly accurate tests that analyze samples of body fluids that are non-invasive and more accessible than traditional tissue biopsies,” said Schatz. “Our liquid biopsy portfolio holds potential to create valuable insights and improve outcomes for patients."

Circulating tumor cells are pivotal to understand the biology of cancer and its metastasis and hold great promise as specimens to help guide treatment decisions, evaluate disease burden and monitor tumor progression.

However, due to the scarce amounts of CTCs in blood, their enrichment and characterization represent a major technological challenge.

The proprietary technology from AdnaGen allows a complete solution for the detection and analysis of CTCs for clinical applications. It enriches disease specific tumor cells using magnetic particles in an antibody mixture, an approach called immunomagnetic cell enrichment, then isolates and purifies messenger RNA (mRNA) for analysis using reverse transcription polymerase chain reaction (RT-PCR). A substantial part of AdnaGen's portfolio already was being built on and marketed for recommended use with Qiagen's automation platforms and consumable kits.

The partnership with Tokai Pharmaceuticals will leverage the CTC-based liquid biopsy technology for companion diagnostics. It aims to commercialize the first regulated, CTC-based companion diagnostic which is designed to guide the treatment of castration resistant prostate cancer (CRPC) with galeterone.

Tokai's oral small molecule has received Fast Track designation from the FDA and is expected to enter phase III clinical trials in the first half of 2015, using Qiagen's AR-V7 assay in development. The diagnostic test to be paired with galeterone will measure RNA expression in CTCs to detect a biomarker known as androgen-receptor splice variant 7 (AR-V7), which has been demonstrated to predict poor responsiveness to certain oral therapies for metastatic CRPC.

It will run on Qiagen's Rotor-Gene Q MDx detection platform, a member of the QIAsymphony family of automated instruments.

Prostate cancer is the second most frequently diagnosed malignancy among men. An estimated 1.1 million cases were diagnosed worldwide in 2012 and 300,000 patients died, according to the World Health Organization. In Europe, prostate cancer struck about 400,000 men and claimed 92,000 lives in 2012. The American Cancer Society predicts more than 220,000 new cases of prostate cancer in the U.S. in 2015, with 27,000 fatalities, making it the No. 2 cause of cancer deaths in American men.

The CTC test for Tokai will be developed by Qiagen Manchester, the global center for the development and regulatory approval of Qiagen's molecular diagnostic applications.

Qiagen acquired certain technology and other assets from AdnaGen, a subsidiary of Alere, including the CE-IVD marked products AdnaTest BreastCancer and AdnaTest Prostate Cancer, which already are marketed in Europe and offer improved treatment monitoring and earlier detection of tumor relapse.

Financial terms for the AdnaGen acquisition and the Tokai partnership have not been disclosed.