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
Sign In

Researchers Say It’s Time to Reclassify Cancerous Tumors Based on Their Molecular Makeup; New System Suggested Would Affect Pathologists’

More than 12 cancer types were studied in this project, which is a part of The Cancer Genome Atlas

New molecular and genetic knowledge is making it possible for researchers to propose a new system for classifying tumors. Upon implementation, such a system will give oncologists and pathologists, and clinical laboratory professionals a new tool to improve how they diagnose and treat cancer patients.

Tumor categories—defined by cell types instead of where they are found in the body—may lead to more accurate diagnoses and more effective treatments for one in 10 patients, according to the recent study. It was summarized in a Medline Plus Health News By Date story posted on the National Institutes of Health (NIH) website. (more…)

To Help Physicians and Patients, Medical Laboratories with BRCA Breast Cancer Tests Are Posting Mutation Data into ClinVar’s BRCA Database

Innovative use of crowdsourcing allows pathologists and genetic scientists to create a sizeable database of BRCA mutations that is accessible to clinicians and patients

There’s a new development in the longstanding battle over proprietary healthcare data versus public sharing of such information. Pathologists and clinical laboratory managers will be interested to learn that, when it comes to genetic testing of the BRCA mutation involved in breast cancer, a public data base of mutations is growing so rapidly that it may become the world’s largest repository of such information.

It was last year when the Supreme Court ruled in the gene patent case of Association of Molecular Pathology versus Myriad Genetics that human genes were not patentable. Following that decision, some financial analysts stated that Myriad Genetics, Inc. (NASDAQ:MYGN) retained a competitive advantage over other medical laboratories due to its huge database of mutations in the BRCA genes. (See Dark Daily, “Supreme Court Strikes down Myriad Gene Patents in Unanimous Vote; Decision Is Expected to Benefit Clinical Pathology Laboratories,”  July 1, 2013.) (more…)

Cigna to Preauthorize Genetic Tests

Clinical laboratories and pathology groups serving Cigna beneficiaries can expect to see new requirements for genetic tests used to diagnose breast cancer, colon cancer and long QT syndrome

Effective this week, Cigna (NYSE: CI) in Bloomfield, Connecticut, is implementing a new program that requires genetic counseling and pre-authorization for certain genetic tests. This is an important development and clinical laboratory executives can expect to see other health insurers take similar steps.

Cigna wants to control costs and improve the appropriateness of ordering expensive genetic tests. It will start with tests for three conditions and may require counseling for other types of genetic tests if this program is successful. Industry observers expect other health insurers will follow Cigna’s example and also require genetic counseling for a compelling reason: all insurers recognize that more than 50% of all genetic tests may be ordered inappropriately, experts say.

(more…)

New York Times Writes about Pathologists’ Misdiagnoses of Breast Cancer Cases

Variability in the accuracy provided by pathologists at different hospital laboratories is highlighted…


Pathology misdiagnoses for selected types of breast cancer was the subject of a New York Times story this week. In recent days, Newsweek and several other newspapers across the nation picked up the theme and published their own stories centered on misdiagnoses of breast cancer.

Such extensive media coverage elevates public awareness of the role of pathologists in diagnosing disease—but, in this case, not in a positive way. However, media attention on these types of issues should not surprise pathologists and clinical laboratory managers. It is consistent with the trend of consumers becoming ever more educated and sophisticated in their knowledge of healthcare.

(more…)

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.

(more…)

;