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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Pathologists and Clinical Labs Can Expect to See More Companion Diagnostic Tests

Pharmaceutical Companies Partnering with IVD Manufacturers to Develop Companion Diagnostic Tests for their Therapeutic Drugs

Growing acceptance of companion diagnostics is a trend with the potential to greatly increase the value that clinical pathology laboratory testing delivers to physicians, patients, and payers. In 2010, it was increasingly common to see a pharmaceutical company announce an agreement with an in vitro diagnostics (IVD) manufacturer to develop a companion diagnostic test specifically for a therapeutic drug under development by that pharmaceutical company.

As most pathologists and clinical managers know, use of a companion diagnostic test is expected to add precision to the physician’s decision to prescribe therapeutic drugs. Thus, the increased number of public announcements during 2010 about companion diagnostic test development deals involving a pharmaceutical company and an IVD manufacturer indicates this trend is establishing solid roots. (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!

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