IVD: thought-provoking observations and predictions about in vitro diagnostics

March 19, 2013

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

The Congressional Budget Office and the Joint Committee on Tax currently estimate that the coverage provisions of the Affordable Care Act will result in approximately 30 million newly insured people by the end of the decade. These patients may choose to receive more medical check-ups and routine diagnostic tests than they did prior to being covered.  As a result, labs will need to look for additional opportunities to operate more efficiently in order to conserve costs and maintain quality amid increases in testing demand. Some of these opportunities are expected to be in areas of consolidation, standardization, and optimization of the laboratory operations.

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

With the increasing occurrence of airborne illnesses during peak winter months, heightened attention has been paid to the influenza virus particularly since the H1N1 pandemic of 2009. Though the gold standard for diagnosing influenza is by viral culture or PCR, many rapid influenza tests have proven their importance as the reliability and accuracy of detecting various strains of the influenza A & B virus has increased. They also serve an often overlooked purpose, which is ruling out other potential respiratory infections that, if not accurately diagnosed and treated in a timely fashion, may cause significant health problems. Some of these health conditions include, but are not limited to, RSV, mono, and strep A, all of which can exhibit symptoms similar to those of influenza. Since most rapid flu tests will provide a result within 15 minutes or less, prompt and appropriate treatment can easily be administered. In addition, the time and cost associated with the viral culture of a sample can have an adverse effect on a facility’s ability to maximize its overall profitability, which is vital in today’s tough economy. The importance of a high-quality and accurate rapid flu test is relevant as never before.

— Andrew Hurdle, MBA

Marketing Manager

LifeSign, LLC

Provider of Status Flu A&B Test Kit

Many predict an FDA-cleared diabetes IVD

Hemoglobin A1c (HbA1c) determination is one of the most commonly employed tools used to guide the management of diabetes. With HbA1c’s well known advantages over blood glucose determinations, as well as the ever-increasing rate of diabetes, a high throughput HbA1c is an essential tool for the clinical lab. Column chromatography-based tests can be price prohibitive, leaving many labs to opt for immunoassay methods. Unfortunately immunoassay tests can suffer from inaccurate and unreliable results when presented with patients having a hemoglobin variant such as sickle cell. This disadvantage causes many labs to maintain both a column chromatography method as well as an immunoassay method during initial patient screening.

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

R&D Manager

Pointe Scientific

Provider of HbA1c reagents, calibrators, and controls

New insights from sequencing

One factor likely to drive future developments in in vitro diagnostics, especially in oncology, is the ability to gain greater insight into the genetic pathways of disease. Few technologies have more potential to influence this direction than next generation sequencing (NGS).

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

Roche Diagnostics

POC testing integral to IVD services

IVD tests are going mobile! Not mobile in the conventional sense, but by being increasingly accessible in locations where their results lend the greatest value. Attribute this to growing demand for point-of-care (POC) tests that provide actionable results—typically within 30 min—to increase patient outcome and/or clinical workflows. POC testing is already integral to healthcare systems’ IVD services and its applications are expanding dramatically.

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