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

NIH Plans To Create New Genetics Testing Registry of Molecular Diagnostics Tests Offered by Clinical Pathology Laboratories

Comprehensive genetic test database intended for use by pathologists, physicians, researchers and consumers


Pathologists and clinical laboratory managers will soon have a comprehensive registry of genetic tests that they can consult as needed. The National Institutes of Health (NIH) is creating a single public registry with detailed information about both genetic test providers and the 1,600+ genetic tests these providers offer.

The NIH believes the genetic test registry will bring greater transparency to the field. It hopes that the registry creates increased information-sharing about the different genetic tests which are available. Participation in the registry will be voluntary, though groups such as the Genetic Alliance have called for making it mandatory to help weed out what they call “the bad actors” in the industry.

(more…)

Many Genetic Tests Offered to Consumers Over the Internet are Misleading and of No Practical Use

GAO Gives Congress a Poor Report on Direct-to-Consumer Genetic Tests Sold by Web-Based Companies

According to the Wall Street Journal, Direct-to-consumer (DTC) genetic tests from the four companies 23andMe, Navigenics, deCODE genetics, and Pathway Genomics Corp, are generating results “that are misleading and of little or no practical use.”  This was the finding of the U.S. General Accounting Office (GAO) in its recently released report.

Pathologists and clinical laboratory managers will be interested to know that the GAO sent multiple specimens to these four companies—each of which is organized to sell genetic tests and molecular diagnostics directly to consumers via the Internet. The GAO determined that, even when given identical DNA samples, the tests from these four companies yielded contradictory results.
(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…)

Why Health Insurers Want to Pre-Authorize Genetic and Expensive Clinical Pathology Lab Tests

McKesson Corp. and MuirLab working to implement lab-friendly strategies to meet payer needs

Unfolding events make it likely that genetic testing will become a good news/bad news story for local clinical laboratories and pathology groups. The good news is that genetic tests and molecular assays will bring more diagnostic precision to patients and their physicians—and that points to an auspicious future for pathology and laboratory medicine.

The bad news is that payer requirements in the United States for pre-authorization of genetic tests may lock-out most local laboratories as providers for these specialized and important clinical laboratory tests. That’s the irony of this developing trend!

(more…)

New Study on How Consumers Use PHRs Has Good News for Clinical Pathology Laboratories

Medical laboratory test data represents an essential component of the patient health record

It will soon be the era of patient health records (PHRs), based on data gathered during a survey conducted by the California HealthCare Foundation (CHCF). That has implications for clinical laboratories and pathology groups across the United States, since most laboratories now electronically report laboratory test results to physicians and their patients.

Press coverage of the study, titled “Consumers and Health Information Technology: A National Survey” following its release last month, touted the findings that wealthier individuals tend to use PHRs more, but that those with lower incomes and chronic conditions who use PHRs tend to benefit the most.

(more…)

;