QIAGEN N.V. (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) has reached an agreement to acquire Cellestis Limited (CST: AU) for approximately A$341 million (US$355 million) in cash, providing QIAGEN with access to a novel "pre-molecular" technology that offers a new dimension in disease detection not currently possible with other diagnostic methods.
The acquisition of Cellestis, a publicly listed, profitable company headquartered in Australia, will provide QIAGEN with exclusive rights to QuantiFERON® technology, a proprietary approach for disease detection and monitoring.
Cellestis has successfully commercialized this technology with QuantiFERON®-TB Gold In-Tube (QFT), a leading test for latent tuberculosis (TB), and is in the early stages of commercializing QuantiFERON®-CMV for monitoring of disease risk from the life-threatening cytomegalovirus (CMV). These tests are approved and commercialized in various countries and are believed to have significant untapped market potential.
QuantiFERON® is a patent-protected platform technology that can provide information on diseases far earlier than possible with other diagnostic methods. QuantiFERON® tests whole blood samples for the presence of systemically amplified molecular analytes which provide information from the immune system's memory.
Based on its ability to provide diagnostic information far earlier than DNA-based molecular tests, QuantiFERON® is considered a "pre-molecular" testing technology. As a result, tests based on QuantiFERON® can even provide critical information on latent infections, where pathogens (bacteria, viruses, fungi) are present in such low amounts that they are not detectable with traditional DNA-based molecular diagnostics.
QuantiFERON® is complementary to QIAGEN's portfolio of molecular diagnostics. Its high sensitivity and ability to provide clinically relevant information means that this technology can be used ahead of DNA- or RNA-based molecular testing. Greater use of QuantiFERON® technology can help guide and drive the use of traditional DNA- and RNA-based molecular diagnostics. For example, patients identified through QuantiFERON®-based tests to be at risk for certain diseases could then proceed for subsequent testing or increased monitoring with corresponding DNA- or RNA-based molecular diagnostics to assess disease activity levels and guide treatment decisions.
"We believe next-generation DNA- and RNA-based molecular testing can benefit from greater use of QuantiFERON® technology, which has a unique ability to identify patients at risk from potentially life-threatening diseases. The power of QuantiFERON® can help save lives by enabling medical treatment through earlier, deeper and much more sensitive disease detection than previously possible," said Peer Schatz, Chief Executive Officer of QIAGEN N.V. "Cellestis has developed a technology that is highly complementary to our portfolio and which we expect to migrate onto our QIAsymphony, QIAensemble and our point of need platforms, thereby adding a new, unique assay menu to these QIAGEN platforms. We believe the addition of Cellestis will further strengthen our capabilities to offer innovative sample and assay technologies that are making improvements in life possible."
"Cellestis has succeeded in developing QuantiFERON® as a breakthrough technology, via the QFT-TB test that is becoming the standard for latent TB diagnosis," said Cellestis CEO Anthony Radford. "We believe QIAGEN as an industry-leading company provides the best strategic fit in terms of capabilities and resources. As part of QIAGEN, we will be able to accelerate our growth much faster than as a stand-alone company and offer even greater benefits to patients and healthcare providers."
Following successful completion of the transaction, QIAGEN plans to migrate QuantiFERON® onto QIAensemble, a next-generation high-throughput automation system in development and nearing market entry; QIAsymphony, a highly versatile automation system for low- to mid-throughput volumes available around the world; and QIAGEN's point of need testing platforms acquired from ESE GmbH.
Successful commercialization of QuantiFERON® technology
Cellestis has launched, depending on regional regulatory approvals and clearances, two commercial diagnostic products and has several new products based on QuantiFERON® technology under evaluation. It has also developed an extensive R&D program targeting other diseases and conditions. In the fiscal year ending June 30, 2010, net sales rose 17% to A$40.4 million (US$42.0 million). Profit from operations before tax and non-recurring items in FY2010 was A$10.2 million (US$10.6 million), up 26% from FY2009.
Its flagship product, QuantiFERON®-TB Gold In-Tube (QFT), accounts for the majority of current sales and was launched in 2006 as a third-generation test for detection of latent tuberculosis (TB). QFT is recommended in many national guidelines since the test overcomes significant shortcomings of the previous standard test used to detect latent TB: the 110-year-old Tuberculin Skin test (TST). Benefits of QFT include its accuracy and significantly improved workflow, making it the only next-generation assay which has been widely commercialized in an instrument and kit format. Most latent infections today cannot be detected using DNA-based molecular diagnostics. QFT is available in many markets and has been approved in many countries, including the U.S. (pre-market approval, or PMA), Canada and Japan and has been CE marked for use in Europe.(3)
Cellestis' other commercialized diagnostic product is QuantiFERON®-CMV(4) which was launched in 2009 and is the first commercially available test designed to allow physicians to monitor a person's risk of cytomegalovirus (CMV) disease. CMV is one of the most common and problematic viral infections in immunosuppressed patients (in cancer, transplantation, HIV therapies). QIAGEN has DNA-based molecular diagnostic tests for CMV viral load testing which could be complemented by QuantiFERON®-CMV to monitor patients for risk of CMV-induced disease.
Products based on QuantiFERON® technology can enhance QIAGEN's leading portfolio in DNA- and RNA-based molecular diagnostics:
- Prevention example: QFT is rapidly expanding as a new treatment standard for testing asymptomatic patients for latent TB infection (and identifying those at risk for active disease), and it is expected to be synergistic with QIAGEN's leading portfolio of real-time PCR and Pyrosequencing DNA-based molecular diagnostic detection technologies which, depending on the indication are use as adjunct tests or reflex/subsequent tests.
- Profiling example: QuantiFERON®-CMV has the potential to accelerate the fast-growing leadership position of QIAGEN in providing a broad range of diagnostic testing solutions for use in monitoring immunosuppressed patients for life-threatening infectious diseases. These patients are being treated with medicines that suppress the body's immune system, which increases the risk for infections. QuantiFERON®-CMV is expected to be synergistic with QIAGEN's DNA- and RNA-based molecular tests used in transplantation medicine. QIAGEN plans to submit a PMA application with the U.S. Food and Drug Administration (FDA) in 2011 for approval of the artus RG PCR CMV test.
- Personalized healthcare examples: Several new classes of medicines require patients to be free of latent TB in advance of treatment initiation, creating new opportunities for QFT. In addition, a number of medicines require patients to be free of viral infections and other pathogens or clinical profiles, which could be verified with tests based on QuantiFERON® technology.
- Point of need example: QuantiFERON® technology will be adapted for use with QIAGEN's ESE detection technology, a battery-operated mobile device, and in particular QFT for latent TB testing in areas without immediate access to a laboratory.