Month: October 2010

Dark Daily

October 25, 2010 “Intelligence: Late Breaking Lab News”

Southern California’s always-crazy lab testing marketplace has a new laboratory competitor. In recent months, Richard Nicholson re-entered the business by acquiring West Pacific Medical Laboratory, based in Santa Fe Springs, California. He is assembling a team of experienced professionals to put his new laboratory company on the path to sustained growth. MORE ON: Nicholson Nicholson …

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Spate of Lab Informatics Deals Signals Greater Investor Interest

DURING OCTOBER, three laboratory informatics companies were acquired or obtained new capital funding. It is an indication of the growing importance that laboratory informatics will play as healthcare moves toward the goal of the universal patient health record (EHR). The first of the three transactions came on October 7. Halfpenny Technologies, Inc., of Blue Bell, …

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Clinical Labs and Whole Human Gene Sequencing

CLINICAL LABORATORY ADMINISTRATORS AND SENIOR EXECUTIVES would be well advised to pay close attention to our lead story about the whole human genome sequence collaboration just announced by the pathology department at Beth Israel Deaconess Medical Center (BIDMC) and GenomeQuest, Inc. (See pages 3-6.) Together, the two organizations intend to be among the first in …

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“Primary-Care Pathology” One Goal at Beth Israel

CEO SUMMARY: In a pioneering collaboration, the pathology department at Beth Israel Deaconess Medical Center in Boston, Massachusetts, will work with GenomeQuest, Inc., to perform whole genome sequencing of tumor specimens. GenomeQuest will handle sequencing, assembly, and annotation of the genetic data. BIDMC will analyze these whole human genome sequences to develop companion diagnostic tests …

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Q3 Earnings Are Mixed Bag For the Two Blood Brothers

IF THERE IS A NOTABLE EVENT in the laboratory testing marketplace during 2010, it is that one of the nation’s billion-dollar lab testing behemoths has reported three consecutive quarters of declines in the number of test requisitions it handled, when compared to the same quarters during 2009. In the memory of THE DARK REPORT, one …

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Growing Role for Digital Image Analysis in Pathology

CEO SUMMARY: For more than three years, pathologists at Washington University in St. Louis have worked with several different scanning products and digital pathology systems. Step-by-step, the Pathology Department has learned important lessons in how to capture digital images, archive them, then make them available on demand to the pathologists. WU currently captures images from …

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Early Warning on LDTs and Pre-Authorization

ANY PATHOLOGIST OR LABORATORY MANAGER who considers this to be a quiet time in the laboratory testing industry is setting themselves up for a rude awakening in the not too distant future. Several stories in this issue are written specifically to call attention to major developments in the profession of laboratory testing. First is the …

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Lab Industry Unprepared For FDA Action on LDTs

CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by the lab industry press is the simple fact that, if the FDA were to …

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Many Questions About FDA Regulation of LDTs

CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprietary tests. Although that is true, any move to regulate LDTs also has the potential to cover …

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Systems Approach For Pre-Authorization Of Genetic Tests

CEO Summary: Pre-authorization of expensive genetic and molecular tests is a threat to local clinical laboratories and pathology groups if payers exclude them from provider networks in favor of labs which bid the lowest prices. But one major healthcare corporation believes there is now an opportunity for clinical labs and pathology groups to deliver added …

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