Kaiser Permanente’s announced acquisition of Seattle-based Group Health Cooperative is big, adding nearly 590,000 covered lives to Kaiser’s already extensive reach on the West Coast, in the Pacific Northwest, and beyond. Among the many things that remain unknown about the joining of the two integrated health care organizations is how the deal will affect Group Health’s laboratory operations.

Another item from this month’s “Put It on the Board” section. Read the whole shebang.

During a session at the Association for Molecular Pathology’s annual meeting in November, Rep. Michael Burgess, MD (R-Tex.), said he expects the Food and Drug Administration to issue its long-awaited final guidance on laboratory-developed tests during the first quarter of 2016.

FDA officials, meanwhile, have been more circumspect in their public statements. In a recent meeting of the CDC’s Clinical Laboratory Improvement Advisory Committee, Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, described the agency’s potential action on LDTs in 2016 using the conditional “if.”

When the FDA released its proposed regulatory framework for LDTs in July 2014, it sparked criticism from virtually every side. What perhaps few expected was that 2015 would slip by without agency action on the matter.

The lead item in this month’s “Put It on the Board” section. Read the whole shebang.

Multiplex PCR panel tests for viral and gastrointestinal pathogens as well as the rapid identification of bloodstream infections can detect more pathogens more quickly than traditional microbiology methods. The question that continues to bedevil is how to offer this newer breed of tests.

The panels, offered by manufacturers such as BioFire, Luminex, and Nanosphere, come with hefty price tags that have prompted difficult questions about their appropriate use. Should multiplex PCR panel tests be restricted in some way, reserved for the sickest patients or those whose immune systems are compromised? Or should the door be open for clinicians to order them as they see fit?

My cover story in the January issue of CAP TODAY. Read the whole shebang.