November 1, 2011 (Vol. 31, No. 19)

Qiagen Boasts Broad Purview from Molecular Biology to Molecular Diagnostics

Qiagen was established in 1984 in Dusseldorf, Germany. The company initially focused on molecular biology with its Plasmid-Kit, which reduced plasmid preparation time from a few days to two hours. Then in 1996, it introduced the BioRobot 9600, a benchtop workstation to automate the purification of RNA, DNA, and proteins.

Today, more than 250,000 researchers and lab specialists in the United States use Qiagen products, and 2 million Qiagen assays yearly are processed by drug companies. Qiagen products are used in the research and development of 2,000 new drugs and in 1,000 clinical trials. Worldwide, Qiagen has more than half a million customers.

Now headquartered in Venlo, The Netherlands, Qiagen sells more than 500 products for pre-analytical preparation of biological samples, diagnostic assays, and instruments to automate entire work flows. The company’s customers include molecular diagnostic laboratories, pharmaceutical and biotechnology companies, and academic researchers.

Qiagen’s assay technologies include a broad panel of molecular diagnostic tests, such as the digene HPV Test for identifying high-risk types of human papilloma virus (HPV).

In 2005, Qiagen expanded its portfolio from sample-preparation kits to molecular diagnostic detection kits. “It was a natural extension of our relationship with customers. If you provide them with kits to isolate a virus from blood, the next step is to provide assays and reagents to identify the virus,” says Ulrich Schriek, Ph.D., svp, corporate business development.

Qiagen develops assays and biomarkers for infectious diseases, cancer, and personalized medicine. “Our goal is to develop the broadest portfolio of assays,” says Dr. Schriek.

A key workhorse to meet that goal was introduced in 2009—the QIAsymphony SP/AS instruments and the Rotor-Gene Q (RGQ) cycler. This integrated system automates sample preparation and work flows. The QIAsymphony AS is ideal for laboratories that perform complex PCR-based molecular testing daily. Nucleic acids are purified on the QIAsymphony SP instrument, and then the samples are transferred to the QIAsymphony AS module, which performs assay setup.

Next, the RGQ carries out PCR and data analysis. Commercial assays and laboratory-developed tests can be combined with the QIAsymphony RGQ system.

The Rotor-Gene Q cycler carries out PCR and data analysis.

Cellestis’ QuantiFERON

Qiagen continues to expand. Among its newest acquisitions is Cellestis, whose premolecular testing platform detects infectious diseases that lie latent in the body. Some bacteria, viruses, and fungi hide in the body and are present at such low levels that traditional DNA- and RNA-based tests cannot detect them. “They are like Trojan horses,” says Dr. Schriek.

The technology from Cellestis, called QuantiFERON®, detects latent tuberculosis, which infects millions of people worldwide, yet is active in only about 10% of them. QuantiFERON identifies patients at risk for tuberculosis, assesses disease activity, and guides treatment. The test uses whole blood samples and amplifies molecular analytes to provide information about a specific reaction of the immune system.

A QuantiFERON test for cytomegalovirus is currently being developed and other tests will follow. The QuantiFERON TB test is approved for in vitro diagnostic use in the United States, Europe, and Japan.

QuantiFERON is a leading in vitro diagnostic tube test based on the activity of cell-mediated functions of the immune system. People exposed to infectious diseases have specific T-cell lymphocytes that maintain an immunological memory for disease-related antigens. When a disease antigen is added to blood collected from a primed person, antigen-specific effector T cells rapidly release the cytokine interferon-gamma (IFN-γ). The QuantiFERON technology is based on stimulation of effector T cells in whole blood with a specific antigen and measuring levels of IFN-γ in plasma.

QuantiFERON complements Qiagen’s portfolio of molecular diagnostics. Patients identified through QuantiFERON-based tests as being at risk for a disease can be monitored with corresponding DNA- and RNA-based molecular diagnostics to assess disease activity and guide treatment decisions. “It’s a very important step for us to go beyond the sensitivity of molecular testing,” says Dr. Schriek.

The QIAsymphony was designed for laboratories that perform complex PCR-based molecular testing daily.

Other Acquisitions

In June, Qiagen acquired Ipsogen, providing access to biomarkers related to various blood cancers. “So far, all other products address solid tumor types like metastatic colon cancer and non-small-cell lung cancer. Now with Ipsogen we can look at cancer in blood cells,” notes Dr. Schriek.

Ipsogen’s assays are based on the same PCR quantitative technology used by Qiagen in many of its own assays. This enables a smooth and rapid transfer of Ipsogen’s products onto Qiagen’s QIAsymphony RGQ system.

Ipsogen provides 80 tests divided into four assay families that are designed to diagnose and monitor BCR-ABL (chronic myeloid leukemia), JAK2 V617F (various myeloproliferative diseases), PML-RARA (promyelocytic leukemia), and products for rare forms of leukemia. The top-selling group involves molecular assays for mutations of the JAK2 (Janus kinase 2) gene, which is associated with various blood cancers.

Early in 2011, Qiagen acquired a strategic stake in Alacris Theranostics, a German start-up company founded by researchers at the Max Planck Institute for Molecular Genetics. Alacris uses next-generation sequencing, algorithms, and an IT infrastructure to predict therapies and treatments based on sequence data from a patient’s tumor. The system, called ModCell™, addresses a critical bottleneck in personalized medicine solutions.

The technology identifies biomarkers from a vast array of genetic data to guide treatment decisions. The platform also creates biomarker subsets to stratify patient populations for clinical trials. Biomarkers such as nucleic acids can be formatted into real-time PCR-based assays that Qiagen will commercialize through its pharmaceutical development assay portfolio or its Therascreen® molecular diagnostics portfolio.

“Through our partnership with Alacris we will channel new kinds of biomarkers into our molecular diagnostic pipeline,” says Dr. Schriek, to expand the QIAsymphony-based personalized healthcare portfolio.

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