QIAGEN gains access to Cellestis’ early disease detection technology

Tests for TB and CMV virus will provide synergies with QIAGEN’s existing assay portfolio and pipeline

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VENLO, The Netherlands—Using a "scheme ofarrangement"—defined as a court-approved agreement between a company and itsshareholders or creditors used to execute arbitrary changes in the structure ofa business—QIAGEN NV has reached an agreement to acquire Cellestis Ltd. forapproximately $355 million in cash, providing QIAGEN with access to a novel"premolecular technology that offers a new dimension in disease detection notcurrently possible with other diagnostic methods," according to the company'sannouncement.
The acquisition of Cellestis, a publicly listed, profitablecompany headquartered in Melbourne, Australia, will provide QIAGEN withexclusive rights to QuantiFERON technology, a proprietary approach for diseasedetection and monitoring.
Products based on QuantiFERON technology can enhanceQIAGEN'S portfolio in DNA-and RNA-based molecular diagnostics in four ways,says Peer Schatz, the company's CEO, citing prevention, profiling, personalizedhealthcare and point of need as "the four Ps."
Cellestis has successfully commercialized this technologywith QuantiFERON-TB Gold In-Tube (QFT), a test for latent tuberculosis, and isin the early stages of commercializing QuantiFERON-CMV for monitoring ofdisease risk from the life-threatening cytomegalovirus (CMV). These tests areapproved and commercialized in various countries and are believed to havesignificant untapped market potential.
"The potential for the four Ps, which make up our Moleculardiagnostics (MDx) portfolio, is very high," says Schatz. "Molecular diagnosticsgrew 12 percent in 2009 to $4.1 billion. And these growth figures were alreadylow due to the financial crisis. Among the four Ps, personalized healthcare(PHC) is considered to have the greatest potential. Between 1999 and 2009, theoverall market for PHC amounted to $13 billion, reflecting a CAGR of 24percent."
QIAGEN's PHC business is growing at an annual rate of 40percent, he adds.
QuantiFERON is a patent-protected platform technology thatcan provide information on diseases far earlier than possible with otherdiagnostic methods. QuantiFERON tests whole-blood samples for the presence ofsystemically amplified molecular analytes, which provide information from theimmune system's memory. Based on its ability to provide diagnostic informationfar earlier than DNA-based molecular tests, QuantiFERON is considered a"premolecular" testing technology. As a result, tests based on QuantiFERON caneven provide critical information on latent infections, where pathogens(bacteria, viruses, fungi) are present in such low amounts that they are notdetectable with traditional DNA-based molecular diagnostics.
QuantiFERON is complementary to QIAGEN's portfolio ofmolecular diagnostics. Its high sensitivity and ability to provide clinicallyrelevant information means that this technology can be used ahead of DNA- orRNA-based molecular testing. Greater use of QuantiFERON technology can helpguide and drive the use of traditional DNA- and RNA-based moleculardiagnostics. For example, patients identified through QuantiFERON-based teststo be at risk for certain diseases could then proceed for subsequent testing orincreased monitoring with corresponding DNA- or RNA-based molecular diagnosticsto assess disease activity levels and guide treatment decisions.
"We believe next-generation DNA- and RNA-based moleculartesting can benefit from greater use of QuantiFERON technology, which has aunique ability to identify patients at risk from potentially life-threateningdiseases. The power of QuantiFERON can help save lives by enabling medicaltreatment through earlier, deeper and much more sensitive disease detectionthan previously possible," says Schatz. "Quantiferon is very a good fit withthe QIAGEN portfolio. The products can be ported onto QIAGEN instrumentation,in particular QIAensemble, our automation platform for prevention. Not only TBand CMV, but also other Cellestis products currently under development arecomplementary with QIAGEN assays. We believe the addition of Cellestis willfurther strengthen our capabilities to offer innovative sample and assaytechnologies that are making improvements in life possible."
Since the acquisition is still subject to various approvals,Schatz declines to comment on plans for integrating Cellestis' employees and facilitiesinto QIAGEN's operations.
"Cellestis has succeeded in developing QuantiFERON as abreakthrough technology, via the QFT-TB test that is becoming the standard forlatent TB diagnosis," comments CEO Anthony Radford, noting that the testreplaces the 110-year-old Tuberculin skin test. "We believe QIAGEN provides thebest 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-alonecompany and offer even greater benefits to patients and healthcare providers."
Following successful completion of the transaction, QIAGENplans to migrate QuantiFERON onto QIAensemble, a next-generation,high-throughput automation system in development and nearing market entry;QIAsymphony, an automation system for low- to mid-throughput volumes nowavailable around the world; and QIAGEN's point-of-need testing platforms.
Cellestis has several new products based on QuantiFERONtechnology under evaluation targeting other diseases and conditions. In thefiscal year ending June 30, 2010, net sales rose 17 percent to $42 million.Profit from operations before tax and non-recurring items in FY2010 was $10.6million, up 26 percent from FY2009. Its flagship TB test accounts for themajority of current sales.
Cellestis' other commercialized diagnostic product isQuantiFERON-CMV 4, which was launched in 2009 and is the first commerciallyavailable test designed to monitor a person's risk of CMV, one of the mostcommon and problematic viral infections in immunosuppressed patients (incancer, transplantation and HIV therapies).
QIAGEN has DNA-based moleculardiagnostic tests for CMV viral load testing that could be complemented byQuantiFERON-CMV to monitor patients for risk of CMV-induced disease. 

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