Clinical laboratory testing in the United States has become increasingly decentralized over the last two decades, according to an article published in the November issue.
Once limited mostly to hospitals, lab testing has since expanded to commercial clinical labs, physician office labs, and even to consumers using over-the-counter devices. Many drivers for this “triangulating dynamic shift” exist, including the increasing use of point-of-care (POC) testing, the article stated.
To gain insight on how these changes might impact the $56 billion laboratory industry over the next decade or so, the article’s authors invited clinical laboratory leaders from hospital-based and commercial settings and traditional in vitro diagnostic (IVD) and POC industries to take part in a question-and-answer session.
An excerpt from the article’s Q&A highlights responses from each of the participants:
Q: What are the main advantages of outsourcing laboratory testing from traditional hospital-based testing, if any?
Norman Moore, PhD, director of scientific affairs for infectious diseases at Alere Inc.: The main advantage is that outsourcing usually saves cost per test. Reference laboratories can more easily batch and run assays to limit technician time and assay expense. However, we are finding that the cost savings on a test level are not balanced by the cost on a patient level in most instances. Outsourcing necessitates a time delay to results, and that can have a direct impact on guiding the physician to the best therapy decisions.
Q: How do you see the dynamic shift in testing between hospital-based laboratories, commercial laboratories, and POC in the next 5 and 10 years?
Charles S. Eby, MD, professor of pathology, immunology and medicine and associate chief of laboratory and genomic medicine at Washington University School of Medicine: Hospitals will continue to consolidate into regional integrated healthcare systems and they will standardize laboratory instrumentation, test methods, menus, reference ranges, laboratory information system and electronic medical record software, and transportation services… Laboratory medical directors will at best blunt the growth of POC testing by championing clinical utility over convenience as they address an insatiable clinical demand for faster turnaround time for selected chemistry, hematology, and hemostasis tests in emergency and critical care areas.
As healthcare reform advances, how will this change where IVD testing is performed?
Susan Evans, PhD, founder of BioDecisions Consulting and vice president for scientific affairs at Beckman Coulter: It is always challenging to predict the future, but the Affordable Care Act, accountable care organizations (ACOs), and other factors will impact where and how much laboratory testing is performed. There will be an increased awareness of the value of laboratory results but also the costs associated with testing…Test utilization per patient will be scrutinized and assessed on the basis of delivered value. An important trend will be a shift to wellness and preventative care.
Is the traditional IVD industry reacting to these changes? If yes, how?
Harvey W. Kaufman, MD, senior medical director at Quest Diagnostics: In a vibrant free market, entrepreneurs and inventors will develop improved testing solutions that meet the needs of the market. The established IVD companies will continue to invest in new technologies and acquire companies that offer novel solutions.
What are the main challenges for expanding the role of POC?
Edward R. Ashwood, MD, professor of pathology at the University of Utah School of Medicine and vice president for government relations at ARUP Laboratories: Test mix is a formidable challenge for POC testing…Companies that manufacture POC devices will be well served to concentrate on the high-volume tests. Successful implementation will allow them to amortize the high development and regulatory costs over a large number of units. POC testing will grow to about a hundred of the most common tests.
Pick up the November issue of Clinical Chemistry to read more expert views about the triangulation of clinical lab testing.