American Association for Clinical Chemistry
Better health through laboratory medicine
July 2007 Clinical Laboratory News: Industry Profiles

July 2007: Volume 33, Number 7

 Qiagen to Acquire Digene

After more than a decade of collaboration, a $1.6 billion transatlantic acquisition will bring Gaithersburg, Md.-based Digene and its exclusive cervical cancer test under Qiagen’s (Venlo, The Netherlands) already broad portfolio of sample and assay consumables and molecular test kits. “The strategic rationale for this transaction is compelling, as it combines Qiagen’s leading technology portfolio and our breadth of molecular diagnostic tests with Digene’s leadership in what is seen as the fastest-growing segment of molecular diagnostics,” said Qiagen CEO Peer Schatz. “The joint franchises link virology with oncology, thereby creating an exceptional platform to add next-generation and high-value molecular diagnostics products and strategically position the company for future growth.” Currently, Digene has the only HPV screening test that is both FDA-approved and CE marked. Digene CEO Daryl Falkner said that as a subsidiary of Qiagen, his company would attain a broader geographical reach and be able to offer a larger portfolio of products. Pending shareholder approval, the companies expect the deal to close in August or September of this year.

Inverness Medical Innovations Buys Cholestech

On the heels of its acquisition of Biosite, Inverness Medical Innovations (Waltham, Mass.) announced a stock-for-stock merger agreement with Hayward, Calif.-based Cholestech Corporation, maker of rapid, point-of-care instruments for heart disease and diabetes testing. “We expect that the acquisition of Cholestech, especially when coupled with our recent and pending acquisitions, will provide Inverness with the unique ability to assess cardiac risk, diagnose cardiac conditions, and potentially monitor the condition and response to therapy of cardiac patients,” said Inverness CEO Ron Zwanziger. “The large installed base of Cholestech systems in physicians’ offices will also be helpful as we continue to expand into this market segment.” The merger still requires shareholder and regulatory approval.

Hologic, Cytyc Merge

Echoing other recent biotech acquisitions that have brought together imaging and in vitro diagnostic companies, mammography device maker Hologic (Bedford, Mass.) announced it will buy Cytyc (Marlborough, Mass.) for $6.2 billion in cash and stock, creating a larger company that Hologic said will focus exclusively on women’s health. Cytyc sells the ThinPrep Pap test, currently the most widely-used system for cervical cancer screening in the U.S. “This combination brings together two well-respected industry leaders in the women’s healthcare and diagnostics marketplace,” said Hologic CEO Jack Cumming. “Both Hologic and Cytyc provide some of the most advanced technology addressing women’s health needs. By combining our companies’ complementary, best-in-class products and technologies, we expect to drive enhanced growth and value creation.” The deal, which the companies said they expect to close later this year, is still subject to shareholder and regulatory approval.

Osmetech Licenses Roche Hot Start System

Osmetech (Pasadena, Calif.) announced that it obtained a non-exclusive, worldwide license for Roche’s (Indianapolis, Ind.) Hot Start polymerase technology to boost its nucleic acid assays. Osmetech said the deal would allow it to include Hot Start polymerase as part of diagnostic kits, giving cost savings and convenience to customers. Osmetech currently has the eSensor electrochemistry-based array instrument on the market, used for cystic fibrosis carrier detection. The company said it has several pharmacogenomic assays in the works, including one for warfarin response, as well as a new model of its eSensor instrument, the eSensor XT8.

LabCorp Inks License, Supply Deals

LabCorp (Burlington, N.C.) signed an agreement to be the first commercial laboratory to offer Roche’s (Indianapolis, Ind.) COBAS HIV-1 test. The Roche assay is a real-time PCR test that uses an automated format to quantify the amount of the virus in blood from very high to very low levels. The FDA approved the test in May. The test will allow patients to receive treatment tailored to their particular level of infection, as well as eliminate several manual steps for the lab, LabCorp officials said.

LabCorp also announced a license agreement with Veridex, LLC (Warren, N.J.) for a nucleic acid test to detect methylated GST-Pi, a tissue marker in prostate cancer. When used in combination with conventional histopathology, an assay quantifying the level of methylated GST-Pi may provide a more sensitive and accurate detection of prostate cancer than histology alone, LabCorp said. “A quantitative PCR assay specific for methylated GST-Pi will be a valuable diagnostic tool to help clinicians resolve difficult-to-diagnose prostate cases and reduce the anxiety many patients experience when the status of their condition is uncertain,” said Myla Lai-Goldman, MD, Executive VP and Chief Science Officer and Medical Director for LabCorp. Financial terms of the deal were not disclosed.

Bio-Rad Purchases DiaMed,
Extends Beckman Coulter Agreement

Bio-Rad (Hercules, Calif.) announced it signed a deal to acquire the Swiss diagnostic firm DiagMed (Cressier sur Morat), which makes a line of reagents and instruments for blood typing and screening. Bio-Rad will pay approximately 477 million Swiss francs for the majority of DiaMed’s shares. “DiaMed has an outstanding reputation for quality products and customer care, and we believe this portfolio of products will fit in well with Bio-Rad’s existing diagnostics business,” said Bio-Rad’s VP and Clinical Diagnostics Group Manager John Goetz. DiaMed is known for its DiaMed-ID micro typing system in serology laboratories.

Bio-Rad also said it has extended a developing and manufacturing agreement with Beckman Coulter (Fullerton, Calif.) for eight more years. Begun in 1997, this deal includes plans for immunodiagnostic tests for blood viruses and infectious diseases. Under the extended agreement, Bio-Rad will develop new immunoassays for Beckman’s UniCel and Access instruments, including hepatitis B envelope antigen and antibody (HBe Ag and Ab). Bio-Rad said it will also develop a next-generation HIV combo assay. Beckman Coulter’s VP of the Immunoassay Business Center said that the partnership would help the company expand its immunoassay business.

CombiMatrix Splits from Acacia

Acacia Research (Newport Beach, Calif.) and CombiMatrix (Mukilteo, Wash.) announced that the Securities and Exchange Commission cleared the way for CombiMatrix to become a separate public company on August 15. As of that date, every 10 outstanding shares of Acacia Research-CombiMatrix stock will be redeemed for one share of CombiMatrix Corporation. “The separation of our two companies will enable each to execute its business independently, and we are excited about the future prospects of our company as we re-invent ourselves with a focus on molecular diagnostics and personalized medicine,” said Amit Kumar, PhD, CombiMatrix CEO.

CombiMatrix Molecular Diagnostics (Irvine, Calif.), the wholly-owned subsidiary and commercial laboratory of CombiMatrix, recently entered the prenatal testing market with the launch of its Constitutional Genetic Array Test, which can identify over 50 common genetic disorders for postnatal or prenatal analysis. The test uses the company’s new Bacterial Artificial Chromosome array.