American Association for Clinical Chemistry
Better health through laboratory medicine
November 2009 Clinical Laboratory News: Industry Profiles

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November 2009: Volume 35, Number 11

Qiagen Acquires PCR Rights from Roche, Idaho Technology

Qiagen announced that it has acquired licenses from Roche and Idaho Technology for the use of instrumentation and reagents used in PCR-based molecular testing. The agreements cover thermal cycler rights and real-time PCR methods for diagnostics, as well as high-resolution melting curve analysis technology (HRM). Combined with Qiagen’s Rotor-Gene Q detection platform, this technology is used in applications such as mutation discovery, pathogen detection, and methylation analysis.

With these agreements in place, Qiagen is the first Idaho Technology and Roche licensee to offer HRM-related instruments and reagents in all formats for research and diagnostics worldwide. “This additional intellectual property portfolio enables us to develop and market PCR solutions based on the most advanced technologies for molecular diagnostics,” stated Achim Ribbe, executive director of business development for Qiagen. “It puts us in the position to offer our customers in molecular diagnostics, pharma, applied testing, and life science research the latest PCR technology running on the most versatile platform and covering all markets and fields, including human in vitro diagnostics.” Financial terms of the agreement were not disclosed.

Osmetech, Fisher Healthcare Terminate Distribution Deal

Osmetech announced that following discussions with Fisher Healthcare both companies have mutually agreed to terminate their U.S. distribution agreement, effective immediately. The two companies originally signed a 5-year distribution agreement in March 2009 for Fisher Healthcare to distribute Osmetech’s eSensor XT-8 instrument platform and molecular diagnostic tests. Osmetech stated that it made the decision to build its own direct sales force with the objective of targeting key molecular diagnostic testing laboratories and clinics that monitor the administration of certain therapeutic drugs. The company’s sales force will expand over the next 3 years as the molecular testing market grows and more tests are added to the eSensor XT-8 platform.

Sequenom Completes Investigation, Fires Executives for Mishandling Prenatal Test Data

Sequenom announced that it has completed its independent investigation related to test data and results for the company’s noninvasive prenatal test for Trisomy 21 (Down syndrome). The investigation concluded that Sequenom failed to use adequate protocols and controls when conducting studies in the Trisomy 21 program and that certain employees also failed to provide adequate supervision, resulting in unsubstantiated claims, inconsistencies, and errors being reported to the public. Sequenom has terminated employment of its presidents and chief executive officer, Harry Stylli, PhD, and its senior vice president of research and development, Elizabeth Dragon, PhD, along with several other employees. A special committee has begun implementing measures to address these issues, including new procedures for the conduct of research and development and clinical studies and new procedures for the storage and management of samples for testing. At CLN press time Sequenom was unable to provide a schedule for the completion of research and possible development for its Trisomy 21 test, but indicated that it continues to believe the underlying science is sound and useful for the development of new diagnostic tests.

Correlagen to Develop Gene Tests with Helicos

Correlagen Diagnostics purchased the Helicos Genetic Analysis System from Helicos Biosciences, and the two companies announced plans to collaborate on future genetic tests. The Helicos Genetic Analysis System is the first and only commercially available single molecule sequencing technology that enables genetic analysis without DNA ligation or amplification. Correlagen plans to use the system for genetic tests based on the targeted resequencing of genes involved in cardiology, endocrinology, neuropsychiatry, and immunology. Helicos and Correlagen will collaborate on optimizing methods of sample preparation, as well as on data analysis and visualization technologies for sequence variant detection, annotation, and clinical reporting. “We believe that the Helicos System will allow us to provide DNA-based clinical assays on unprecedented value for the diagnosis of genetic disorders,” stated David Margulies, chairman and chief executive officer of Correlagen.

Thermo Fisher Completes Purchase of BRAHMS

Thermo Fisher Scientific completed its acquisition of BRAHMS for €330 million, or approximately $470 million. BRAHMS will be integrated into Thermo Fisher’s Analytical Technologies Segment, and its headquarters in Hennigsdorf, Germany will serve as Thermo Fisher’s European Center of Excellence for its clinical diagnostic business.

Veridex’s Tumor Cell Test Wins Best Medical Technology Award

The CellSearch Circulating Tumor Cell (CTC) Test developed by Veridex has been honored with the first-ever Prix Galien USA 2009 Award for Best Medical Technology. The CellSearch system is the first diagnostic test used to automate the detection of CTCs—tumor cells that have detached from solid tumors and entered the patient’s bloodstream. The test helps determine the prognosis and survival of patients with metastatic breast, colorectal, or prostate cancer during the course of treatment. Candidates for the Prix Galien USA Award are evaluated on innovation, applicability, and future uses to biomedical science. It is considered the industry’s highest prize for research and development.

Gen-Probe Buys Prodesse for $60 Million

Gen-Probe signed a definitive agreement to acquire Prodesse for approximately $60 million in cash, with the possibility of future milestone payments pushing the purchase price up to $85 million if Prodesse achieves certain financial and regulatory objectives in 2010 and 2011. As part of the acquisition, Gen-Probe’s sales representatives were expected to begin co-promoting Prodesse’s products in mid-October across the U.S., Canada, and Europe. “Our acquisition by Gen-Probe validates the significant progress we have made in developing and commercializing molecular assays that help doctors and laboratories diagnose respiratory and other infectious disease more accurately than traditional methods,” said Tom Shannon, president and chief executive officer of Prodesse. “We believe we can prepare for and accelerate our stage growth by leveraging the resources and expertise of one of the most established and highly respected molecular diagnostics companies in the world.” Both companies’ boards of directors have unanimously approved the transaction and the deal was expected to close by early November.