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

May 2007: Volume 33, Number 5

Beckman Coulter to Buy Biosite
In another major industry acquisition, Beckman Coulter (Fullerton, Calif.) announced it will acquire San Diego, Calif.-based Biosite in a $1.55 billion stock transaction. Beckman Coulter said the deal would make it a leading provider of immunoassay tests, especially cardiac diagnostics. Biosite’s Triage brand rapid tests for CVD and drug screening are used in over 70% of U.S. hospitals. “A major source of value in the transaction is our ability to leverage our global commercial infrastructure and installed base to expand sales of Biosite’s immunoassay tests, including BNP,” said Scott Garrett, CEO of Beckman Coulter. “Longer term, we will have significant opportunities to leverage Biosite’s pipeline of novel diagnostic tests across our large installed base of automated systems in hospital laboratories.” Garrett said the deal will also expand Beckman Coulter’s presence in near-patient testing.
Roche Bags Two Companies in Spending Spree

Roche (Basel, Switzerland) announced a $600 million merger agreement under which it will acquire BioVeris, a diagnostic and biosecurity company based in Gaithersburg, Md. For Roche, the acquisition will mean owning the complete patent estate of the electrochemiluminescence (ECL) technology that Roche applied in its Elecsys product line under license from BioVeris. “ECL is a highly innovative technology. In comparison with other detection technologies, ECL offers distinct advantages such as enhanced sensitivity, short incubation times, and broad measuring ranges,” said Severin Schwan, CEO of Roche Diagnostics. “This acquisition ensures that Roche will be able to provide unrestricted access to all customers and therefore represents a significant growth opportunity for our immunochemistry business.”

Roche also inked a deal to acquire Branford, Conn.-based 454 Life Sciences for $140 million. Founded in 2000, 454 Life Sciences is a majority-owned subsidiary of CuraGen Corporation (Branford, Conn.) and is known for its ultra-fast gene sequencing technology. The two companies have an existing research and marketing collaboration, and Roche is the exclusive worldwide distributor of 454’s Genome Sequencer systems. The acquisition will give Roche access to 454’s future generations of sequencing products and the use of 454 sequencing for in-vitro diagnostics, Roche said.

3M Joins Fray of Big Firms
Jostling for Diagnostic Market
Starting with methicillin-resistant Staphylococcus aureus and other treatment-resistant microbes, 3M Health Care (St. Paul, Minn.) announced the launch of a clinical diagnostics business focused on developing and commercializing rapid tests for the detection of key pathogens. “3M Medical Diagnostics is a natural extension of our infection prevention platform and enables us to offer hospitals a full spectrum of products that detect, prevent, and treat infections in the hospital setting,” said Angela Dillow, PhD, Global Business Manager, 3M Medical Diagnostics. “We see many market trends pointing to the need for rapid, easy-to-use microbial diagnostics that will aid in the prevention and control of infections in the U.S. and abroad.” The company said the new products will roll out later this year.
Abbott Donates Lab Equipment
in “Labs Are Vital” Campaign
Abbott announced that the first phase of its $1 million instrument donation program has awarded diagnostic equipment, supplies, and service to clinical laboratory educational programs at 16 accredited schools. Part of Abbott’s “Labs Are Vital” education and awareness campaign, the company selected the 16 schools from more than 100 online applications. “Talking about automation in labs does not adequately prepare new laboratorians for what they will experience once they move on to the hospitals for their clinical rotations,” said Becky Clark, Assistant Professor and head of the Medical Laboratory Technology program at J. Sargeant Reynolds Community College in Richmond, Va., which received one of the donations. “Until now, the best I have been able to do was to take them on a field trip to see one of the state’s high-tech labs. This grant from Abbott will help us move our program into the 21st century.”

Sequenom Plans Non-invasive Prenatal Test

Sequenom (San Diego, Calif.) announced it will develop a non-invasive prenatal Rhesus D (RhD) incompatibility test in collaboration with Lenetix Medical Screening Laboratory (Mineola, N.Y.), a specialty reference laboratory focusing on prenatal genetic screening. Sequenom said it will market the test as a home-brew assay. “The non-invasive characterization of fetal Rh genotype and other fetal genetic information has the potential to transform the practice of prenatal risk assessment,” said Lenetix President Leonard Kellner. “This new approach to non-invasive evaluation of a baby in utero is a very exciting scientific and commercial development and may significantly reduce the need for invasive fetal diagnostic tests, such as amniocentesis or chorionic villus sampling.” Sequenom plans to begin marketing the test by the end of June. Financial terms of the deal were not disclosed.
Osmetech Licenses Marker
for Warfarin Management
Osmetech (Pasadena, Calif.) announced a non-exclusive license from the University of Washington (Seattle) for vitamin K epoxide reductase gene polymorphism (VKORC1), a key genetic marker for the management of warfarin dosage. “This deal gives Osmetech Molecular Diagnostics access to a very important biomarker for warfarin and positions us as a significant player in this new era of personalized medicine and companion diagnostics,” said Osmetech CEO James White. “We are particularly excited in light of the pending FDA mandate for more stringent warfarin safety labeling and the cost-effective approach that our eSensor platform provides for global markets.”
OraSure Makes Deal Toward
FDA Review of Rapid OTC HIV Test

In preparation for FDA’s review of its OraQuick ADVANCE rapid HIV-1/2 antibody test for OTC sales, OraSure Technologies (Bethlehem, Pa.) recently signed a deal with healthcare IT services company Constella (Durham, N.C.) for a telephone and internet consumer counseling and referral system. “We have initiated design work on a consumer counseling and referral system and are pleased to have Constella onboard to complete the process,” said Douglas Michels, CEO of OraSure. “With their extensive experience in professional health services, and in particular their experience in international markets and in designing and operating the CDC’s HIV/AIDS call center here in the U.S., Constella is ideally suited to help develop a robust, state-of-the-art and fully compliant consumer counseling and referral system. We look forward to completing the development of a prototoype system that will be validated and included in our clinical studies for OTC approval of our OraQuick ADVANCE test by the FDA.”

Under the agreement, Constella will develop a system with phone and Web site access 24 hours a day, 7 days a week. The OraQuick test is already CLIA waived and in use in various public health, drug treatment, and outreach settings. The test provides results in 20 minutes from oral fluid, fingerstick, or venipuncture whole blood or plasma specimens. OraSure said that it continues to conduct clinical studies on the packaging and labeling of an OTC version of the test and might submit a premarket application for FDA approval as soon as 2008.