Diagnostic testing

EHM. How have recent advances in technology, automation and IT influenced diagnostic testing?

CM. The primary driver of technological advancements in medical diagnostics has been the development of faster, more accurate devices that not only streamline operations and provide connectivity with electronic medical records in the lab setting but also provide patients with greater care in the physician’s office. The overall impact is access to a more rapid result, introduction of more timely and appropriate medicine, reduction in costs associated with use of inappropriate medication, and unneeded additional testing, improved quality control, and less time in the hospital or clinic waiting rooms for the patient.

PR. There are some incredible developments in technology that are fuelling interest in decentralized or PoC testing. For many years, manufacturers created versions of instruments that were smaller and easier to use than existing models, and they were adequate for the decentralized testing customers. However, we are now witnessing a new era with systems designed specifically for PoC. The new systems are battery powered for use in remote settings and they allow lab-quality testing to be brought to patients for whom lab testing would not otherwise be available. We will soon see CD4 and CD8 counts being performed on portable lab-on-a-chip systems that will make the lab monitoring of patients on AIDS therapy possible in the remote corners of the globe.

IT developments now allow the PoC testing results to be entered in to the desk top or lab information system of the healthcare provider, thereby allowing all centralized and decentralized lab results to be recorded electronically and uploaded in to the patient’s electronic medical record– a key requirement for tracking purposes.

RW. Technological innovations represent new and promising means for physicians to better diagnose and manage their patients. Understanding when and how to use these new tools can be a challenge even for well-versed sub-specialists. This is particularly true for molecular diagnostic tests in oncology, genetics, and infectious diseases. Providing a clearer understanding of the indications for optimal clinical use and result interpretation of these new tools is an important means to providing better patient care and better utilization of these expensive resources. To that end, ARUP Laboratories has developed the “free-ware” tool ARUP CONSULT1, designed to provide a web-based, PDA-based, physician-friendly format to the use and interpretation of both common and unusual diagnostic tests. Within the clinical laboratory, the continued development and deployment of automated pre-analytical, analytical and post-analytical instrumentation further improves the quality, cost and turnaround time of many laboratory tests.

EHM. There is an ongoing debate on whether or not Point of Care (PoC) testing offers advantages over central laboratory testing. Where do you stand in this debate?

RW. PoC testing will continue to expand in scope, quality, and cost-effectiveness, driven by the same forces that drive it today: patient and physician convenience, and rapidity of appropriate physician decision-making. As with any technology the balance between expediency and cost-effectiveness will influence the extent of its deployment in a variety of patient care settings. However, primary emphasis should be placed on the value that PoC places on the clinical care process. The continuum of “rapid/high cost” to “slow/low cost” clinical laboratory services is dynamic and situational dependent, so that what is performed in the PoC setting, the rapid response clinical laboratory, the central core laboratory and/or the reference laboratory will vary from health care organization to organization.

PR. There really should be no debate. There are patients and situations that cry out for accurate and rapid point of care testing, and there are situations that make centralized testing the most appropriate option. So-called esoteric tests that require a very high skill level to perform and for which no PoC system exists clearly need to be performed in a centralized laboratory. Tests that can be batched and performed inexpensively and reported back the next day or even later in the same day are often adequate to meet the needs of physicians. Those tests can be done in a centralized facility. If a physician has been treating a patient for years for a chronic illness, speed may not be required for monitoring, but there are many examples wherein immediate test results provide significant value for the patient.

On the other hand, a patient who presents at a public health clinic and may have used public transportation to get there, perhaps took unpaid leave from work, may not be able to return for follow-up visit, is an ideal candidate for PoC testing. Similarly, having the ability to perform a white blood cell count to test a child for an elevated count in conjunction with a physical exam may help reduce the unnecessary use of antibiotics. The other key advantage of PoC testing is the opportunity to immediately interact with the patient akin the advantage of testing for high blood pressure.
In the final analysis, total cost to treat the patient and measuring the outcomes should determine the options. Much work has to be done in this area to move the argument away from simply comparing the cost per test.

CM. As a manufacturer of the QuickVue brand of rapid diagnostics, our entire value proposition rests on the fact that rapid testing at the PoC makes sense from both a clinical and economic perspective. With the integration of PoC coordinators in the hospital setting, the acute care laboratory has accepted certain rapid tests that have proven clinical and economic benefits to these facilities.

Our brand represents accuracy, quality and evidence-based data supporting the use of rapid tests in infectious disease, reproductive health and in screening for fecal occult blood – an indicator of possible colorectal cancer. Quidel is committed to providing evidence-based proof for the clinical and economic benefits of our tests. We have trademarked this standard as Quidel Value Build (QVB). Many of our studies, including analytical and clinical studies, are regularly presented at key professional and scientific meetings by healthcare professionals who gainfully use rapid testing in their various practices, including hospital laboratories, emergency room laboratories, PoV clinics, and retail clinics.

EHM. How can physicians diagnose patients more rapidly and at the same time cost-efficiently?

PR. There are many examples of how using PoC testing in the emergency department can lead to efficient processes to move patients through a ‘clogged artery’ in the hospital. Having the appropriate tests available can speed the diagnosis and treatment choices. There is more to come in this area and in the future we can expect to see many novel devices and systems in use in hospitals.

RW. At the risk of being redundant, physicians need to have ready access to information that facilitates the use of the correct laboratory test, the correct result, in the correct clinical situation, and at the right time. Whether it is PoC, from a hospital clinical laboratory, or from a reference laboratory, these clinical laboratory principles hold for physician and health system alike. Accuracy and speed, in that order, should take priority. Cost-effectiveness should be considered beyond just that of the diagnostic test itself. If an expensive laboratory diagnostic procedure, or series of procedures, lead to the correct diagnosis and management decision in the shortest period of time, then, from a total episode-of-care perspective, the process has been both clinically and cost-effective. This attention to the impact of laboratory diagnostics on downstream clinical decisions is always important to bear in mind.

CM. Rapid tests yield accurate results usually in 10 minutes or less and include controls that indicate that the test device has worked properly. In addition, external analyte controls are usually provided for further quality control. The products are often CLIA waived, attesting to the simplicity and accuracy of the tests while simultaneously greatly reducing the quality assurance, training, and documentation burden on the physician and staff. Our tests are used extremely effectively in ways to improve efficiency and cut costs. A recent study conducted by Dr. Aleta Bonner2 of the Dell Children’s Medical Center of Central Texas showed that the impact of correctly employing a rapid diagnostic test, such as for influenza, can greatly reduce overall costs by limiting the use of unneeded tests, avoiding the use of inappropriate medications and reducing the number of repeat visits to the hospital or clinic.

EHM. How do you ensure that you provide healthcare professionals with the most accurate information possible?

CM. We hold our manufacturing to the highest standards and provide products that meet our strict quality standards, thus helping to ensure product performance in the hands of our customers. We ensure that our clinical studies fully meet best clinical practices and that the performance of our products are based on comparison to the existing gold standards. We make a special effort to understand the performance of the test, not only in expert laboratorians’ hands, but also in the hands of professional staff more commonly encountered at the PoC. We conduct head to head comparisons with competitor kits to ensure that our products are of the highest quality.

RW. Most clinical laboratory tests, when used in the appropriate clinical setting, are very accurate and clinically effective. For the price, laboratory testing is still one of the best deals in health care – 70 percent of medical decision-making at approximately two to three percent of total health care spending – and an important means for improving patient safety. Providing physicians and other health care professionals with a clearer understanding of the indications for optimal clinical use and result interpretation of laboratory tests is an important means to providing better patient care. Appropriate utilization of laboratory resources is one of the best means to assure that physicians diagnose and manage their patients in a safe and clinically effective way, minimizing unnecessary testing, unnecessary downstream costs, and/or testing that delays their decision-making and appropriate clinical intervention.

PR. The newest devices provide lab-based quality at the PoC. As newer instruments are developed for this market and as simpler user-friendly devices become available we see this issue get resolved. Many systems today have lockout options that shut the instrument down if it is not appropriately calibrated or in control and many systems have excellent menu-driven modes that help protect against errors. In spite of these developments, training and monitoring of users is critically important, especially in the hospital setting where hundreds of devices can be used by hundreds of employees, the majority of whom are not trained laboratorians. This is a challenge for industry to design appropriate devices with appropriate user-interfaces to guarantee a quality result.

EHM. Where do you see the future of diagnostic testing?

RW. The promise of targeted therapy – personalized medicine – is
beginning to be realized. The clinical laboratory will play an important role in this regard. The idea of coupling a diagnostic test to the “indications for use” of a therapeutic agent is now mainstream. Examples of these “companion diagnostics” include: the finding of the BCR/ABL1 translocation in chronic myelogenous leukemia as an indication for use of imatinib, and the finding of the mutations in cytochrome P450 2C9 gene that necessitate lower dosages of the common anti-coagulant warfarin to prevent potentially serious bleeding complications.

Another promising technology falls into the FDA’s category of In-Vitro Diagnostic Multivariate Index Assays (IVDMIA), which couple the measurement of a multitude of analytes, for example DNA or protein expression profiling in malignant tumors, with complex computer-analyzed algorithms in order to diagnose and/or predict the biological behavior or therapeutic responsiveness of specific conditions; complex analytic instrumentation linked to powerful computational computers.

PR. Having been in the lab diagnostics industry for more than thirty-five years, I have witnessed many changes and I have also seen how slowly some things that seem to be inherently useful are slow to change. We are about to witness dramatic developments in decentralized testing, driven in part by huge opportunities in nations developing medical lab testing in a big way. Hand-held, wireless devices, lab quality testing and the development of micro arrays will lead to new options for testing and more choices for healthcare providers and patients.

CM. We know that changes and advances in technology will affect the future landscape. Some segments may require further automation and certainly prognostic testing through molecular diagnostics are already on the horizon. Access to rapid testing, allowing the testing and immediate treatment of patients where they live, shop, and work will continue to fuel the growth of CLIA waived tests. We are already seeing access at retail clinics through nurse practitioner models as well as over the counter tests for some disease or condition states.

1. The “free-ware” tool ARUP CONSULT is accessible at www.arupconsult.com.
2. Dr. Aleta Bonner’s study is entitled Impact of the Rapid Diagnosis of Influenza on Physician Decision-Making and Patient Management in the Pediatric Emergency Department: Results of a Randomized, Prospective, Controlled Trial.
   

Ronald L Weiss

President & Chief Operating Officer, University of Utah ARUP Laboratories.
Dr. Weiss is a professor of pathology at the University of Utah and is board certified in anatomic/clinical pathology, microbiology, and hematology by the American Board of Pathology. Dr. Weiss is currently the chairman of the board of the American Clinical Laboratory Association (ACLA) and president-elect of the American Pathology Foundation (APF). He is a fellow of the College of American Pathologists (CAP) and the American Society of Clinical Pathologists (ASCP). Dr. Weiss received his M.D. from Crieghton University and his M.B.A. from the University of Utah.

Paul L. Rust
Vice President, Point of Care Testing for Quest Diagnostics.
Paul L. Rust joined Quest Diagnostics with the acquisition of SmithKline Beecham Clinical Laboratories (SBCL) in August 1999. Mr. Rust joined SmithKline in 1979 as Marketing Manager for the Geometric Data Division, a diagnostic equipment manufacturer. He held a variety of positions with that division, including Vice President, Worldwide Sales and Marketing. In 1985 he was named Vice President Corporate Accounts for the parent company, then SmithKline Beckman. Mr. Rust is a graduate of the University of Southern Connecticut, with a Bachelor of Arts degree in geography. He is a past president of the Biomedical Marketing Association and of the New York State Clinical Laboratory Association and served as a member of the Board of Directors of the California Clinical Lab Association.

Caren L. Mason
President and Chief Executive Officer, Quidel
Caren L. Mason has more than 25 years experience in healthcare. Prior to joining Quidel, Ms. Mason provided consultative services for Eastman Kodak Health Imaging. She served as President and CEO for MiraMedica, Inc., from April 2002 through September 2003 and CEO of eMed Technologies, Inc. from 2000 to 2001. Prior to joining eMed Technologies, Ms. Mason served as General Manager of Women’s Healthcare business and as a General Manager in various capacities for the Services business of General Electric Medical Systems from July 1996 to January 2000. Additional healthcare experience includes tenure with Bayer AG/AGFA, where she last served as Senior Vice President for the AGFA Technical Imaging Business Group. Ms. Mason began her career in healthcare with American Hospital Supply/Baxter Healthcare and served in sales, marketing and managerial roles from 1977 through 1988. Ms. Mason is a graduate of Indiana University. She currently serves as a member of the Board of Directors of AdvaMed.