College of American Pathologists
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March 2011

Novartis to acquire Genoptix

Pharmaceutical giant Novartis has entered into a definitive agreement to acquire Genoptix, a specialized laboratory providing personalized diagnostic services to community-based hematologists and oncologists.

“The acquisition of the Genoptix medical laboratory will serve as a strong foundation for our individualized treatment programs,” said Joseph Jimenez, chief executive officer of Novartis. “Genoptix is an innovative company with a talented team of people who share our commitment to transforming the way medicine is practiced.”

Genoptix employs about 500 people and will become part of Novartis Molecular Diagnostics, a unit within the Novartis Pharmaceuticals Division. The acquisition will support and expedite the development of companion diagnostic programs, especially in oncology.

Novartis plans to maintain existing operations and continue delivering Genoptix’s portfolio of personalized diagnostic services to hematologists and oncologists.

CMS launches physician comparison Web site

The Centers for Medicare and Medicaid Services has launched a Web site called “Physician Compare.” The site, which users can access at, offers many search functions not previously available.

The CMS expanded the information available to health care consumers in its online physician directory tool, and patients can now determine whether health care providers accept the Medicare-approved amount as full payment for all services. Pathologists are included in the Physician Compare site.

On the site are the physician’s medical specialty, where he or she trained, gender, whether the physician participates in the Medicare program, and other information. This year, the CMS also plans to enable users to search for physicians who prescribe medications electronically to promote adoption of e-prescribing among Medicare physicians. Other expansions are planned for the future.

New software helps in managing blood use

Hospitals can track their blood product use, manage inventory, and compare blood use protocols against best practices through a new management system.

Appropriate Inventory Management, or AIM, is a software system that tracks blood use and provides patient outcome analyses through vein-to-vein monitoring of the blood products by the hospital and blood center. The system was piloted by 16 America’s Blood Centers’ members in more than 340 U.S. hospitals and is based on European systems that have seen significant reductions in the number of units of blood used by hospitals.

The system is being made available to the 75 independent blood centers that are members of America’s Blood Centers.

AIM has a national database of information that will allow blood centers to provide hospitals with individua-lized laboratory, donor, and patient data as well as local, regional, and national data for benchmarking against best practices. The system was designed to help hospitals better manage their blood inventories, reduce waste, and comply with new standards mandated by the Joint Commission.

“The overriding benefit to hospitals will be having data that identifies the transfusion protocols that result in the best outcomes in patients, which is what we all strive for,” said Jim MacPherson, chief executive officer of America’s Blood Centers. “At the same time, hospitals today are examining every line item in their budgets and will welcome the cost savings that have been projected through the use of AIM, as experienced in Europe.”

AIM provides information on the availability of specific blood products, the inventory the hospital is carrying, and unused or outdated units, and it monitors the appropriateness of a blood transfusion. It tracks the outcomes and adverse events associated with the use of the various blood products. The system can automatically monitor for transfusion-associated infections or patient reactions.

FDA OKs HCV rapid test

The FDA has approved OraSure Technologies’ OraQuick HCV rapid antibody test for use in detecting HCV antibodies with a fingerstick whole blood sample. The fingerstick whole blood claim is the second application the FDA approved for the test. It received an initial approval in June 2010 for use with venous whole blood specimens in those at risk for HCV infection.

The point-of-care test provides results in 20 minutes.

“By eliminating the need for a blood draw, health care providers will be able to identify more individuals infected with hepatitis C and get them into care,” said Douglas A. Michels, president and chief executive officer of OraSure.

OraSure entered into agreements with Merck, through its predecessor Schering Plough Corp., to collaborate on the development and promotion of the OraQuick HCV test. Under these agreements, Merck will provide detailing and other promotional support for the test in the physician office markets in the United States and internationally.

Quest to acquire Athena

Quest Diagnostics has signed a definitive agreement to acquire Athena Diagnostics, an esoteric laboratory specializing in genetic testing for neurological disorders, from Thermo Fisher Scientific for $740 million.

Athena generated about $110 million in revenues in 2010. The transaction is expected to be completed early in the second quarter this year and, if so, to add about one percent to Quest’s 2011 revenue growth.

“We expect to further accelerate Athena’s growth by supplementing its specialty sales organization with Quest Diagnostics’ extensive sales force, to sell into our broader customer base,” said Surya N. Mohapatra, PhD, chairman and chief executive officer of Quest. “Strategically, we believe Athena will be the principal beneficiary of the accelerated demand for diagnostic testing as new and earlier therapies are developed for neurological conditions such as Alzheimer’s disease.”

IHC assay guideline revised

The Clinical and Laboratory Standards Institute has published “Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline-Second Edition (I/LA28-A2).” The document, which provides guidelines for developing validated diagnostic, prognostic, and predictive immunohistochemistry assays, is a revision of the previous CLSI document MM04.

The focus of the revised guideline is the application of immunohisto-chemistry and immunocytochemistry for the study of human tumor specimens. This guideline presents information on the total product life cycle of the discovery, design, development, verification, and analytical and clinical validation of IHC and ICC reagents, kits, and systems, while emphasizing that accurate and reliable IHC and ICC results require attention to the total test.

The audience for this guideline includes the assay developer, the reagent supplier, the laboratory histotechnologist who performs the assay, and the laboratory director or pathologist who implements and interprets the assay.