QIAGEN Expands Leadership in Liquid Biopsies

QIAGEN N.V. has announced an important expansion of its industry-leading portfolio of liquid biopsies through the acquisition of an innovative technology that enables enrichment and molecular analysis of circulating tumor cells (CTCs) from blood samples.

QIAGEN also announced a new partnership with Tokai Pharmaceuticals, Inc. to combine this new CTC 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 has demonstrated potential utility to guide therapy choice in CRPC patients. Financial terms for the AdnaGen acquisition and the Tokai partnership were not disclosed.

“We are pleased to expand QIAGEN’s industry-leading pipeline as we pioneer the emerging field of non-invasive liquid biopsies. 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, Chief Executive Officer 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. 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 was already being built on and marketed for recommended use with QIAGEN’s automation platforms and consumable kits.

QIAGEN’s leading portfolio of solutions for pre-analytical processing of molecular biomarkers from blood and other fluids can support customers with liquid biopsies for a wide range of needs:

• Cell-free, circulating nucleic acids (cfDNA), which come predominantly from dying cells released into the blood and other body fluids. This phenomenon occurs in every person, but some physiological states and symptom constellations are associated with a significantly higher concentration, for example in pregnant women or patients with cancers or autoimmune disorders.
• Nucleic acids and proteins circulating in tiny enclosures called exosomes: These microvesicles (very small enclosures) are being shed by cells as part of a biological communication system. Each exosome can carry a tiny cargo of genetic instructions in the form of DNA and RNA molecules through the blood, urine or other fluids. Taking these genomic messages from cell to cell in the body, exosomes are being called the "Twitter of the cells."
• Circulating tumor cells (CTCs) enter the bloodstream from the primary tumor and play an important role in the development of metastases in other parts of the body.

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 U.S. Food and Drug Administration (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.

“We are pleased to be expanding our partnership with QIAGEN to support the continued development of the AR-V7 companion diagnostic that will be used in our 148 patient Phase 3 ARMOR3-SV trial of our lead product, galeterone. We believe that in the future, the availability of this non-invasive AR-V7 companion diagnostic will allow prostate cancer patients and physicians to make informed decisions for their care,” stated Jodie Morrison, President and Chief Executive Officer of Tokai Pharmaceuticals. “QIAGEN’s experience in commercializing regulatory-approved companion diagnostics around the world addresses a key part of our strategy for bringing galeterone to market for CRPC patients globally.”

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 United States 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 GmbH, a subsidiary of Alere Inc., including the CE-IVD marked products AdnaTest BreastCancer and AdnaTest Prostate Cancer, which are already marketed in Europe and offer improved treatment monitoring and earlier detection of tumor relapse.

Leadership in liquid biopsies and personalized healthcare

QIAGEN is at the forefront of offering liquid biopsy-based tests and isolation and enrichment technologies that target molecular biomarkers circulating in blood and other body fluids. Liquid biopsies hold great promise to improve the diagnosis and monitoring of many diseases, in particular cancer, and complement invasive and cumbersome tissue biopsies. In January 2015, QIAGEN introduced the therascreen EGFR RGQ Plasma PCR kit, a companion diagnostic paired with a leading treatment of non-small cell lung cancer when a tumor tissue sample cannot be used. The kit has received CE-IVD marking for use in more than 30 European countries and is the first registered companion diagnostic for solid tumors using liquid biopsies.

QIAGEN is a global leader in providing tissue and liquid biopsy-based tests for personalized healthcare, the strategy of using companion diagnostics to guide the use of medicines for treatment of cancer and other diseases. The company markets tests in various markets covering a broad range of molecular biomarkers and running on PCR, multi-modal and next-generation sequencing platforms. QIAGEN’s growing pipeline includes more than 20 collaborative projects with pharma and biotech companies to commercialize companion diagnostics.