With the expected increase in demand and new healthcare requirements, it is important to recognize the role diagnostics plays in fostering better patient care and cost savings through consolidation, standardization, and optimization. Other points covered in this rountable include the benefits of prompt, appropriate treatment, the prediction of an FDA-cleared IVD for diabetes, new sequencing insights, and POC testing as a component of IVD services.
Consolidation, standardization, and optimization
In terms of standardization and consolidation, there is beginning to be a move from large hospital laboratories at each site to more of a hub-and-spoke approach in order to standardize testing systems and reagents across the entire healthcare network. This evolution of lab operations will help optimize efficiency and cost savings while reducing errors and enhancing quality, which will be critical for outcomes-based reimbursements required by accountable-care organizations.
Additionally, Abbott expects that labs will look to optimize process and information flow to further drive efficiency. Enabling technologies such as automation have helped address some process efficiencies, but there is room for further advances. Evolving capabilities in process optimization via Lean and Six Sigma principles coupled with IT solutions will build further efficiencies in the lab.
The future looks very interesting for laboratory medicine. The recognition of the role of diagnostics in patient care and as an important driver of healthcare cost savings continues to grow, which is great news. However, to keep up with the expected increased demand, and the rapidly changing healthcare environment, labs must rely on consolidation, standardization, and optimization.
— Greg Ahlberg, MBA
Divisional Vice President, Diagnostics
U.S. Commercial Operations
Provider of the ARCHITECT, PRISM, and CELL-DYN platforms
Prompt and appropriate treatment
— Andrew Hurdle, MBA
Provider of Status Flu A&B Test Kit
Many predict an FDA-cleared diabetes IVD
In 2010, the American Diabetes Association published recommendations indicating that HbA1c determinations may be used to diagnose diabetes. However, to date no HbA1c test has been cleared by the FDA with a diagnosis claim. Many predict that, in the near future, the clinical lab will indeed see an IVD cleared for use as a diagnostic for diabetes. This IVD will most likely use an immunoassay method that is both accurate and reliable, and has no significant interference from hemoglobin variants such as HbC, HbS, HbE, HbD, or HbF.
— William Cripps, BSc
Provider of HbA1c reagents, calibrators, and controls
New insights from sequencing
NGS has seen widespread growth due to advancements in technology that improve ease of use and decrease cost, particularly in benchtop sequencing, and high-throughput automated systems. The area that may be poised to benefit the most from the technology advances is translational research, the process of translating scientific discoveries into routine applications, including clinical diagnostics. The ability to examine consequential portions of an individual’s genome in order to identify individualized risk predictions and treatment decisions is now within reach and has the potential to impact clinical decision making globally.
But several challenges must be overcome before NGS can become a part of routine clinical practice. Manufacturers, laboratorians, and regulatory agencies first need to reach greater consensus in several areas, such as the criteria for selection and quality of samples, data quality and reproducibility, bioinformatics handling, and regulatory guidance. In the meantime, research using NGS technology is expected to drive rapidly toward a future that holds greatly enhanced potential for personalized healthcare.
— Christopher Bird, MS, DPhil
Head of Medical and Scientific Affairs—North America
POC testing integral to IVD services
In critical care, POC tests help doctors make life-saving decisions within minutes, not hours, of running a test, using data once only available via the central lab. The ability to quickly and accurately detect lactic acidosis, measure troponin levels, or rule out a pulmonary embolism in acute care situations represent a fraction of what’s now retrievable at the bedside.
For chronic disease management, POC tests increase workflows and provide actionable results to manage major diseases such as diabetes, hypertension, or cardiovascular conditions. Instead of sending out samples that require patients to book another appointment, physicians can test key values such as Hemoglobin A1c, Prothrombin Time, or Microalbumin and make decisions during the same visit.
As more IVD tests become compatible to POC environments, providers will certainly leverage this evolution to further raise quality and productivity of healthcare delivery while addressing life-threatening diseases.
— Peter Koerte, PhD
Vice President, Global Marketing, Point of Care business unit
Siemens Healthcare Diagnostics
Provider of Stratus© CS Acute Care™ Diagnostic System