Clinical Data opposes Citizen Petition

Clinical Data (Newton, Massachusetts) said that it intends to oppose a citizen petition filed with the FDA by Genentech (South San Francisco, California), which requests that the agency regulate more stringently all laboratory-developed tests (LDTs) that are used to guide therapeutic decisions - tests that are the essence of personalized therapies.

Clinical Data's genetic biomarker-based tests, including its PGxPredict tests to assist in predicting a patient's response to specific drugs, have been developed according to current regulatory requirements and are performed in strict compliance with the Clinical Laboratory Improvement Amendments (CLIA). The development and use of these tests are based on sound scientific evidence, and provide demonstrable clinical value in aiding physicians and patients in making more informed treatment decisions.

Clinical Data supports clear and consistent regulatory policy. The company says it also endorses a degree of regulation that is necessary and sufficient. In contrast, the position advocated by Genentech ignores the fact that excessive or inappropriate regulation is a powerful disincentive to the development of innovative healthcare products that improve outcomes while lowering healthcare costs.

SIS to offer seminar in sterilization

Steris Isomedix Services (Mentor, Ohio) is offering a one-day seminar offering industry expertise on topics critical to success in medical device sterilization. The event, being held in San Jose, California on March 11, 2009, will provide attendees the opportunity to learn about sterilization technologies, process validation, materials selection, and much more.

In addition to the TechTeam experts from Steris Isomedix Services, the seminar will feature thought leaders from around the industry. Seminar topics include: Fundamentals of Radiation Processing; Ethylene Oxide (EO) Sterilization Overview; Materials Compatibility and Selection; and Laboratory Services and Techniques. For more information, visit <www.isomedix.com/markets/medical.com.

Bellus Health will delist from Nasdaq

Bellus Health (Laval, Quebec) said that it has provided formal notice to the Nasdaq stock market of its intention to voluntarily delist its common stock from the Nasdaq capital market. The decision was taken in light of the continuing, extreme short-term volatility in current conditions in the financial markets and, accordingly, in the company's market value. The company expects that it will file a Form 25 with the SEC and Nasdaq on or about Dec. 29, 2008, with delisting of its common stock to take effect ten days thereafter. The company's listing on the Toronto Stock Exchange will not be affected by this action.

Bellus Health is a global health company focused on the development and commercialization of products to provide innovative health solutions to address critical unmet needs.

Nashville hospital accredited for HF treatment

Saint Thomas Hospital (Nashville, Tennessee) has achieved the distinction of becoming the first accredited Heart Failure Institute in Tennessee, officials at the Healthcare Accreditation Colloquium (Columbus, Ohio) said.

"This accreditation recognizes the broad based expertise of care that Saint Thomas Heart provides," said Tod Lambert, cardiac service line executive for Saint Thomas Health Services.

The Healthcare Accreditation Colloquium brings quality and process improvement to the care of heart failure patients in the community and hospitals by using improvement-based continuous accreditation. The Colloquium offers an organized and systematic approach to heart failure that encompasses the entire continuum of care. The process is modeled after well-established process improvement methods used in industry. Saint Thomas Hospital exceeded all requirements for accreditation, which included an analysis of current practices, comprehensive report, in-depth interviews, and an on-site visit from surveyors.

IntegraMed subsidiary opens new vein clinic

IntegraMed America (Skokie, Illinois), a provider of specialty healthcare services in emerging, technology-focused segments, said that its subsidiary, Vein Clinics of America (VCA), is opening its 32nd vein clinic location. Located at 5202 Old Orchard Road in Skokie, Illinois, the new office will offer the latest in vein disease diagnosis and treatment.

Ted King, MD, medical director of VCA, said in a statement, that "Treatment options for vein disease continue to advance as the use of laser and other non-surgical technologies take on a more prominent role. It is rewarding for both physicians and patients to see the results we are able to achieve in helping our patients alleviate the discomfort and pain brought on by this progressive condition."