News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Vitamin D Testing: What the Government Giveth, It Taketh Away

New Study to Research if Supplements of Vitamin D, Fish Oil Reduce Health Risks

With the volume of Vitamin D testing skyrocketing in clinical laboratories across the nation, leave it to government bureaucrats to work at counter purposes to each other. With one hand, the federal Medicare program is proposing to restrict coverage guidelines and reimbursement for Vitamin D testing to Medicare patients. With another hand, the federally-funded National Institutes of Health (NIH) is funding a large, multi-year study to assess the effect Vitamin D supplements and fish oil have in reducing health risks!

Researchers at Harvard Medical School will investigate whether taking daily dietary supplements of Vitamin D or fish oil reduces the risk of developing cancer, heart disease, and stroke in people with no previous history of such illness. Under a $20 million grant from the National Institutes of Health Institutes, researchers from Harvard Medical School and the Brigham and Women’s Hospital in Boston, Massachusetts, will recruit 20,000 participants for the study nationwide. (more…)

LabCorp Pays $106.7 Million for Monogram Biosciences in Personalized Medicine Play

Acquisition adds more companion diagnostics to LabCorp’s molecular test menu

Here’s another validation of the prediction that companion diagnostics will be a cornerstone of personalized medicine. Laboratory Corporation of America Holdings (NYSE: LH) of Burlington, North Carolina, said Tuesday (June 23) it would acquire Monogram Biosciences, Inc. (NASDAQ: MGRM) of South San Francisco, California. In an all cash deal totaling $106.7 million, LabCorp will pay $4.55 per share.

“Monogram Biosciences, Inc., has an excellent clinical reputation, a market leading infectious disease test, a market leading companion diagnostic, an exciting technology platform for oncology, and offers LabCorp a substantial growth opportunity,” said David P. King, LabCorp’s Chairman and Chief Executive Officer.

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DNA Vaccine for Horses Holds Promise for Better, Safer Human Vaccines

Milestone demonstration validates effectiveness of DNA vaccine technology in large mammals

Why is registration of a new equine vaccine for West Nile virus generating excitement among biomedical researchers? It represents a breakthrough in DNA vaccine technology, demonstrating this new class of vaccines is viable for human use.

Many pathologists and clinical laboratory professionals will find this news noteworthy for several reasons. First, it is an important milestone in the use of molecular technology to advance genetic medicine. Second, wider use of DNA vaccines will serve the goal of preventive healthcare. Third, should DNA vaccines eventually find a role in protecting humans from a wide spectrum of diseases, this, in turn, will significantly change the role and frequency of laboratory testing for these diseases. Along with other uses, it is because DNA vaccines can target cancers as well as infectious diseases.

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St. Elizabeth Medical Center May Be First U.S. Hospital to Hold Three ISO Accreditations

Utica Hospital holds accreditation in ISO 9001 and 14001, may pursue 15189

When the federal Centers for Medicare and Medicaid Services (CMS) approved DNV Healthcare, Inc. , of Cincinnati, Ohio, to accredit hospitals in the United States last fall, it changed the accreditation landscape significantly. A division of Det Norske Veritas of Oslo, Norway, DNV Healthcare is the first new hospital accreditation competitor for The Joint Commission http://www.jointcommission.org in 40 years. The Joint Commission is the longtime leader in hospital accreditation in the United States.

Among the first hospitals to use this new Medicare accreditation program was St. Elizabeth Medical Center in Utica, New York. One compelling reason why St. Elizabeth used DNV to pursue Medicare accreditation was that it already held ISO 9001 accreditation and the DNV accreditation process enables hospitals to earn accreditation under both programs. Based in its successful experience with DNV and with ISO 9001, St. Elizabeth’s administrators and clinical laboratory managers expect to pursue ISO 15189:Medical Laboratories accreditation within the next two years.

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