QIAGEN announces commercialization of AdnaTest kit for clinical research in prostate cancer

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it is commercializing the Research use only AdnaTest Prostate Cancer Panel AR-V7 to detect the androgen receptor splice variant 7 (AR-V7) from liquid biopsies to investigate resistance to potential drugs for advanced prostate cancer. QIAGEN has acquired an exclusive worldwide license from Johns Hopkins University for detecting the AR-V7 biomarker in all sample and cell types through nucleic acid tests such as polymerase chain reaction (PCR) or next-generation sequencing (NGS). Johns Hopkins researchers have used AdnaTest technology in studies to evaluate the expression of AR-V7 messenger RNA in prostate cancer patients.

"Our AdnaTest workflow unlocks an important biomarker for clinical research to provide for the development of prostate cancer diagnostics in the future. Providing accurate insights from circulating tumor cells in a blood sample, our AR-V7 solution is a significant addition to our portfolio of non-invasive liquid biopsies for Personalized Healthcare," said Thierry Bernard, Senior Vice President and Head of QIAGEN's Molecular Diagnostics Business Area. "We are pleased to partner with the pioneering researchers at Johns Hopkins in developing this workflow. We plan to make the AdnaTest kit commercially available this year, as a Sample to Insight solution for clinical researchers."

Johns Hopkins researchers highlighted the role of AR-V7 variants in understanding response in patients with castration-resistant prostate cancer (CRPC) in a 2014 article in the New England Journal of Medicine. In the study, scientists used AdnaTest workflows for isolation, enrichment and detection of the AR-V7 marker from circulating tumor cells in blood samples using reverse-transcription polymerase chain reaction (RT-PCR).

In 2015 QIAGEN acquired the AdnaTest technology for detecting RNA expression from circulating tumor cells (CTCs) obtained from blood samples as non-invasive liquid biopsies. QIAGEN is currently working with several pharmaceutical companies to field-test the assay for clinical research in prostate cancer. The agreement with Johns Hopkins provides QIAGEN the exclusive worldwide license for detection of the AR-V7 marker.

Prostate cancer is the second most common cancer in men, according to the World Health Organization (WHO). About 1.1 million were diagnosed with prostate cancer worldwide, with an estimated 307,000 deaths, in 2012, the most recent year for which statistics are available. In the United States, the American Cancer Society estimates more than 160,000 men will be diagnosed with prostate cancer in 2017, resulting in more than 26,000 deaths. About one in seven men in the U.S. will be diagnosed with prostate cancer during his lifetime, and it is the third leading cause of cancer deaths for American men.

QIAGEN is a global leader in developing Sample to Insight workflows for non-invasive liquid biopsies in oncology, prenatal testing and other applications. QIAGEN is actively partnering with pharmaceutical and biotech companies to develop companion diagnostics using liquid biopsies and PCR or NGS analysis of biomarkers for stratification or monitoring of patients. In 2015, QIAGEN introduced the first regulated companion diagnostic assay based on molecular biomarkers from circulating tumor DNA. QIAGEN also has collaborations underway using circulating tumor cells and exosomes collected from blood or plasma. Liquid biopsies are easier to perform, less risky and less expensive than tissue biopsies, and they can be repeated at regular intervals for monitoring of disease progression.