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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Genentech Scientists Zero in on “Liquid Biopsies” as a Way to Replace Tissue Biopsies in Breast Cancer

Surgical pathologists could gain new tool to diagnose many types of cancers


It might soon be possible to determine the HER2 status of breast cancer patients from blood samples rather than tissue biopsies. If this new technology proves feasible, it would give surgical pathologists and medical laboratories a different, and possibly less complex, methodology to use when assessing a case of breast cancer.

In its report about the study, Medscape Medical News, wrote that “HER2 status derived from circulating tumor cells (CTCs) from breast cancer patients was generally concordant with that derived from tumor tissue” and that “CTCs could prove to be an alternative to biopsies for assessing tumor tissue for biomarker status.”

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Georgetown University Hospital Suspends Testing at One of Its Pathology Laboratories

Testing ceases following July 19 inspection by officials from CMS and CAP


Last Friday, The Washington Post broke the news that Georgetown University Hospital (GUH) had closed the pathology laboratory that performed certain breast cancer tests. The action—described as an “unprecedented” suspension by GUH Chief Medical Officer Stephen Evans, M.D.—was taken in response to an investigation of the pathology laboratory by federal officials.

The closure of the laboratory followed an inspection on July 19, 2010 by officials from the Centers for Medicare and Medicaid Services (CMS) and inspectors from the College of American Pathologists (CAP). Hospital officials say the molecular testing laboratory in question will be closed as long as four to eight weeks. During this time, specimens are being referred to outside laboratory testing sources.

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Dako Announces Digital Pathology Agreements with Philips and Omnyx

Goal is to deliver integrated digital pathology solutions to clinical pathology laboratories


Yesterday, Dako announced separate digital pathology agreements with Royal Philips Electronics (NYSE: PHG) and Omnyx, LLC. Both the Philips and Omnyx agreements give each company access to Dako’s proprietary software algorithms and reagents used in tissue analysis for certain cancers.

In the deal between Philips and Dako, Philips plans to incorporate certain of Dako’s image analysis applications to the digital pathology system it is currently developing. Breast cancer is the diagnostic area covered by this new agreement. Philips will get access to Dako’s image analysis software for tissue-based breast cancers diagnosis, in tandem with Dako’s reagents for staining HER2, Estrogen Receptor (ER), Progesterone Receptor (PR), p53 and Ki-67 proteins.

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“Poorly-Developed” Clinical Pathology Laboratory Tests Subject of New York Times Story

Times reporter looks at issues affecting accuracy of different breast cancer tests


Pathologists should consider a recent story about breast cancer testing in the New York Times to be a warning flag, similar to the warning flags that the Coast Guard flies along the coast to warn of an approaching hurricane. The subject of the story was “unclear tests” used to identify whether a breast cancer patient is a candidate for certain therapeutic drugs.

The New York Times story was in response to the public release of new guidelines for processing specimens used in estrogen receptor and progesterone receptor (ER/PR) testing for breast cancer. The guidelines were announced by the College of American Pathologists and American Society of Clinical Oncology (ASCO) on April 19, 2010. One goal of the new guidelines is to improve “the accuracy of immunohistochemistry (IHC) testing for the expression status of estrogen (ER) and progesterone receptors (PgR) in breast cancer” as performed by the hundreds of anatomic pathology laboratories in the United States which perform ER and PR testing.

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Thomas Grogan, M.D., of Roche Ventana Medical Systems Provides Pathologist with Predictions about Anatomic Pathology

More multiplex and multi-analyte testing lies ahead for clinical pathology laboratories.

Several experts predict that clinical pathology laboratories will see the use of multiplex assays and multi-analyte diagnoses increase significantly in the near future. As this happens, both the science and the operations of clinical laboratories and pathology practices will grow in sophistication and complexity.

This week at the Executive War College on Laboratory and Pathology Management in New Orleans, Louisiana, almost 600 pathology and laboratory leaders gathered from 12 nations across the globe. During Wednesday’s general session, Thomas M. Grogan, M.D., Founder and Chief Scientific Advisor of Roche Ventana Medical Systems laid out his vision of how surgical pathology will evolve in the future.
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