Feb 22, 2010 | Digital Pathology, Laboratory News, Laboratory Pathology
Firm will submit cytogenetic testing system to FDA using pre-IDE process
High-throughput microarray technology used in cytogenetics research may soon have an FDA-cleared product for use by clinical pathology laboratories.
Array-based comparative genomic hybridization can perform the equivalent of hundreds or even thousands of fluorescence in situ hybridization (FISH) experiments in one array. This technology has become the preferred method for molecular cytogenetics research. Recent advances in the technology are making the system appropriate for use by clinical labs and at least one manufacturer is taking steps to enter this market. (more…)
Feb 17, 2010 | Laboratory News, Laboratory Pathology, News From Dark Daily
February 24 Audio Conference will cover the A-to-Z of Vitamin 25(OH) D Testing
Clinical laboratory testing for Vitamin 25(OH) D continues to the fastest-growing test on the medical laboratory menu, in the United States and other developed nations around the globe. Over the past four years, the steady increase in physician and patient demand for Vitamin D tests has kept most pathology laboratories scrambling to maintain turnaround times and quality.
To help laboratories understand and respond to this unprecedented demand for a simple laboratory test, national Vitamin D expert Bruce Hollis, Ph.D., Director of Pediatric Nutritional Sciences at the Medical University of South Carolina will conduct a special audio conference on February 24 at 1:00 P.M. EST. Pathologists and laboratory professionals will find Dr. Hollis’ session to be an essential and comprehensive explanation of why Vitamin D has become a high profile subject in medicine and how they should position their clinical laboratories to best serve the demand for Vitamin D knowledge and testing.
(more…)
Feb 12, 2010 | Laboratory News, Laboratory Pathology, Uncategorized
Court case will directly affect future development of new pathology and molecular tests
In New York’s Southern District Court, a trial is underway that tests the legality of patenting genes. In Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office 09-civ-4515, pathologist groups, patient advocacy groups, and the American Civil Liberties Union (ACLU) are challenging patents for the BRCA I and BRCA II genes which are held by the University of Utah and licensed exclusively to Myriad Genetics, Inc., of Salt Lake City, Utah.
Many experts believe this lawsuit has the potential to produce new case law that addresses the ability of individuals and companies to hold patents on human genes. A ruling in favor of either party in the lawsuit will directly affect the clinical laboratory testing industry and diagnostic tests that utilize gene-based technologies.
(more…)
Feb 8, 2010 | Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Revised: February 13, 2010
Medhold NV will be acquired for about U.S. $316 million
Sonic Healthcare, Ltd., (SHL.AX) of Sydney, Australia, said last Friday that it would acquire 100% of Medhold NV, a clinical pathology laboratory based in Antwerp, Belgium. Sales price is €232 million, which is about U.S. $316 million. Sonic said the acquisition is conditional upon a small number of closing conditions and is expected to close within two weeks.
Medhold NV is Belgium’s second largest laboratory company. It was created in November 2007 by a merger of AML-Raitol and Medish Labo D Van Waes. Waterland Private Equity became a 50% owner at that time. The clinical laboratory company provides clinical laboratory testing and veterinary testing services.
(more…)
Feb 4, 2010 | Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Sonic Healthcare stock slides on announcement of Medicare Australia funding changes
In Australia, funding for pathology services and clinical laboratory testing is now undergoing review by the government health service. Last month, when news broke that the Australian Department of Health and Ageing was initiating a review of pathology funding, there was an immediate response by the stock market, as reflected in the lower price for shares of Sonic Healthcare, Ltd. (ASX:SHL), Australia’s largest provider of pathology services and clinical lab testing.
(more…)
