By Tiffany Olson

 Tiffany Olson

Laboratory administrators, like other executives, sometimes get so preoccupied with their day-to-day work issues that they fail to adjust to the shifting ground in their industry. The risk of becoming competitively irrelevant is especially pronounced today because of the advent of molecular diagnostics, which, combined with huge advances in laboratory technology, is likely to revolutionize the types of tests laboratories do and even how they are performed.

Societal health care trends also promise to impact laboratories dramatically. In addition, the pace of change is faster than many realize. In some cases, the “future” has already arrived.

For example, in obstetrics, genetic engineering has been a reality for the past decade. Couples who undergo a process called preimplantation genetic diagnosis (PGD), can have embryos tested for genetic diseases and also test gender with 100% accuracy.

To survive in an industry as competitive as health care, you have to be able to see which way the winds are blowing and set your sails accordingly. What kinds of tests will your laboratory need to do in the future? Who will request the tests, and who will run them? Here are some trends and projections that can help guide your choices.

The Changing Face of Health Care
I see five trends that are already having major impacts on the industry, including laboratories. In many cases, these impacts are just a preview of the far-greater changes the trends will bring down the line.

1) Reimbursement. Both large employers and governments are recognizing that quality outcomes save money. As a result, they are starting to identify and track key quality benchmarks. They’re then applying that information in ways that reward high-performing health care delivery systems and penalize low performers. Laboratories are not immune to this trend. Case in point: one of the HEDIS benchmarks is the HBA1C test for diabetics.

2) New infectious agents. Thanks to increased global travel, an infection from almost anywhere can become a pandemic in mere weeks. In 2003, the SARS virus, which started in a remote location in China, infected more than 8,000 people in 30 countries in less than a month. Borders shut down, travel was paralyzed, and economies were affected all over the globe. The threat of a bioterrorist attack is another way that globalization is affecting health care.

Laboratories play a crucial role in these situations. For instance, the spread of SARS spurred hundreds of laboratories worldwide to work on isolating the virus. The crisis also highlighted a knowledge and technology gap, and the lack of a test to diagnose and triage patients.

3) Consumer-directed health care. Consumers today are far better educated and proactively involved in health care decision-making than in the past. In addition, the Internet now gives them the ability to quickly compare service options and price and order tests for illnesses, such as HIV, HCV, and HBV, online. For laboratories, these developments make an already complex marketplace even more diverse and competitive.

4) Demographic shift. In 2000, 12% of the US population was 65 or older. In 2030, that segment will represent 20% of the population, which will burden the health care system with dramatically increasing numbers of cardiovascular, neurological, and other age-related diseases.

5) Labor shortage. As the number of patients increases, the number of workers available to serve them is falling, including in the ranks of laboratory technologists. This not only threatens the quality of care but also increases recruitment costs, and thus health care pricing.

Molecular Diagnostics and the Future of the Laboratory
Despite the magnitude of the challenges facing the health care system, I believe the future is bright for both patients and the industry. Overall, patients suffering devastating illness face far better prospects today than just 5 years ago, and those prospects improve almost daily. Laboratory professionals should also look forward to major improvements. I expect that technological developments will meet most of the challenges posed by global and societal changes, and that the laboratory will lead the charge by deploying molecular diagnostics. What’s more, these laboratory industry–centered changes will impact the very essence of health care.

In particular, the explosion of knowledge about the structure of DNA is revolutionizing diagnosis, treatment, and drug design, and this revolution will continue as the molecular diagnostics field grows. Consider what’s already possible with HCV infection. Physicians are now able to diagnose asymptomatic patients, determine predisposition for disease, tailor treatment protocols proactively, and monitor response rates for therapy efficacy.

The following are five projected developments in molecular diagnostics that I predict will be vital to the survival of laboratories:

1) Molecular diagnostics will soon become as integral to the traditional laboratory as hematology, chemistry, and microbiology are today. Molecular testing will become the MRI of the laboratory, providing the best test for old and new diseases. Laboratories that do not invest in the technology and the talent to run it will be left in the competitive dust. The major value of the technology will not be in reimbursement dollars, however, but in cost reductions throughout the health care system. Testing will expand from acute asymptomatic diagnosis to include predisposition screening and new virus testing. For example, when an emergency room is flooded with new patients during flu season, molecular technology will enable the hospital’s laboratory to rapidly determine if a patient is infected with ordinary influenza or the next generation of Avian flu. This will save time, money, and lives.

2) Molecular technology will increase a laboratory’s value to the health care system. Laboratories are undervalued today. They provide 70% of the information involved in medical decision-making and yet represent only about 4% of a typical hospital’s budget.

Molecular testing will dramatize and expand the laboratory’s value to the health care economy by expanding the information the laboratory provides. Molecular diagnostics can provide early, accurate screening and prediction of diseases in their asymptomatic stages, years before symptoms appear or the diseases actually begin. Intervention—whether a lifestyle change or a pharmaceutical—can start at that early point, perhaps preventing the disease entirely. This ability will allow the health care system to transition from reactive to preventive medicine, improving overall health care efficiency and conserving the ever-dwindling health care dollar.

Molecular tests also increase the value of the health care system to patients by reducing infections, morbidity rates, and mortality rates for acute illness. Consider the ever-increasing sophistication and speed of molecular test development. It took 6 years to develop the HIV monitoring test, 8 months to develop the test for West Nile virus, and just 2 months to develop a diagnostic test for SARS. In the latter case, rapid test development enabled the medical community to restrict the spread of the disease and limit deaths to slightly more than 900. Whenever the next frightening virus appears, molecular diagnostics is the primary tool that will hold it in check.

Molecular diagnostics will also become a lead weapon against resistance to antibiotics, a major hazard in the hospital environment. Today, up to 30% of secondary, antibiotic-resistant infections are contracted in hospitals. The problem is caused largely by physicians who treat empirically, before they obtain test results. But in the future, molecular tests should be able to determine within 2 to 3 hours not only the nature of an infection, but also the resistance of critically ill patients to it. They will offer viable real-time screening for carriers of antibiotic-resistant viruses, as well.

Today, only 7% of laboratories perform molecular testing because it is perceived as highly specialized with relatively few samples available. But molecular tests are being brought to market daily. To remain competitive, hospital and laboratory administrators will need to include these tests in the laboratory’s testing spectrum.

3) Molecular tests will run virtually unattended. Some medical futurists predict that laboratories will eventually be 100% automated, with virtually all the work being performed by instruments, transport systems, and robots. Others go further, envisioning that advances in nanotechnology, genomics, chip technology, and informatics will allow an entire laboratory to be placed on a chip or series of chips. When and if that occurs, laboratory tests of all types will be able to be performed just about anywhere.

But even the more limited vision of a fully automated laboratory means that the hospital’s need for highly specialized technicians will diminish or even end. The equipment will deliver flawless results regardless of operator experience. The vision also suggests that the automated platforms will be accessible and affordable to laboratories of all sizes. The cost effectiveness will extend to the tests themselves, meaning that health care for patients can improve even if the reimbursement situation does not.

While all of this might sound like science fiction, the reality is closer than one might think. Note that microarray chips, the platform of the future, pack the power of a mainframe computer into a matchbook-size package. This is a breakthrough technology that will enable laboratories to process an exponential amount of information compared to today’s molecular platforms. Genotyping and expression microarrays now permit us to do complex gene analysis. These arrays can evaluate hundreds of genes at a time, giving physicians and researchers a powerful tool to predict and diagnosis complex multi-variant conditions, such as drug metabolism, cardiac risk factors, and subtyping infectious agents.

Today, microarrays provide researchers with potent tools for understanding genomics and proteomics, but they will also play a key role in tomorrow’s diagnostic assays. In the near future, physicians will use molecular tests to diagnose and monitor diseases and predict genetic conditions as routinely as they use chemistry and hematology today.

4) The role of diagnostics will expand to include individual responses to customized drug therapies (eg, pharmacogenetics). Physicians will be able to individualize therapy by prescribing the most effective drug for each patient, thus avoiding adverse drug reactions and improving treatment response. Today, patient dosage level is based on age, sex, and weight, as determined by empirical studies. But specific drug metabolism may be as individualized as one’s fingerprint, so imagine the improvement in treatment efficacy if a pharmaceutical dose could be based on one’s specific genetic analysis and not on the outcome of yesterday’s patient.

There are three areas of research within pharmacogenetics — pharmacokinetics, pharmacodynamics, and disease etiology — that molecular technology will specifically impact. Two excellent examples of molecular diagnostic–related success have already occurred within pharmacodynamics. The first is Herceptin®, for breast cancer patients who are positive for the HER2 gene. The second is Gleevec, for chronic myeloid leukemia (CML) in the STI 571, which has transformed therapy for CML patients. In disease etiology, we’re seeing the emergence of blood pressure based on genotype. In the future, molecular diagnostics may be able to direct physicians to the right drug for every patient, no matter what the illness.

Challenges for Laboratories Implementing Molecular Diagnostics
Despite the tremendous promise of molecular diagnostics, laboratories that incorporate it will inevitably face issues that are endemic to any new technology. First, they may struggle to find qualified staff because schools have not kept pace with developments in this field. Second, physicians may be slow to adapt to the test results because of the steep learning curve required for using the results and understanding their impact on ordering and treatment algorithms. Third, laboratories will have to absorb start-up and upgrade costs as they transition from traditional to molecular methods. They will also have to change the way their facility is staffed, organized, and designed.

In addition, the health care culture must change before molecular test results are fully accepted. The medical community and the public are accustomed to illnesses being treated reactively. Molecular diagnostics changes the paradigm to proactive testing and treatment. Laboratories can and should take a lead role in demonstrating the value of the technology to physicians, as well as showing health care administrators how the technology is cost effective. They should also support efforts that show the public the advantages of molecular-based testing and treatment.

The bottom line is that transformative changes wrought by molecular diagnostics—and affected by overall health care trends—are coming, and the changes are largely good ones. It is entirely to the benefit of laboratories, as well as those they serve, to embrace those changes sooner rather than later.

Tiffany Olson is vice president–molecular diagnostics for Roche Diagnostics in Indianapolis. She spoke on molecular diagnostics at the 2004 Executive War College on Lab and Pathology Management. She can be reached at [email protected].