The dizzying pace of laboratory technology adoption is clearly evident in the increasing acceptance of molecular diagnostics by clinical labs of all sizes. Molecular testing has moved from University Lane to Main Street, and it is providing clinicians both in large cities and sparsely populated areas with enhanced abilities to achieve earlier, highly accurate detection of disease. It has made the clinical laboratory a central player in the burgeoning field of personalized medicine.
Ten years ago, few laboratorians would have predicted that community-based labs would routinely perform molecular tests as they do today. Even many in remote locales are running sophisticated gene-based assays to quantitate viral loads in patients with HIV and hepatitis and to determine which new cancer therapies are best suited for specific patients.
What fueled this revolution? I believe four major drivers have enabled molecular diagnosticians to set up shop full time on Main Street: automated molecular testing systems; expanded commercial assay menus for infectious diseases; the emergence of personalized medicine approaches in cancer care; and improved education in genetics and molecular diagnostics for both laboratorians and clinicians. Healthcare reform, including some aspects of the Affordable Care Act, is also playing a role.
Automated systems
Automated molecular testing systems, introduced nearly ten years ago, ignited the spark for eventual broad-based acceptance. Operating ease and simplified testing protocols made it possible for laboratory managers to dream big dreams about applying molecular diagnostics technology to improve patient care in their institutions. Automated analyzers offered great promise in utilizing polymerase chain reaction (PCR) and other molecular detection technologies for identifying and measuring DNA and RNA of infectious pathogens and tumors.
As molecular diagnostics companies began to penetrate the clinical lab market with automated PCR-based systems, they followed the proven immunoassay analyzer playbook and developed many different assays for their instruments. Most were for infectious disease detection and monitoring. Continual menu expansions made these automated systems more profitable for the suppliers while increasing value for laboratories. An analyzer that can run 10 different tests obviously offers greater value and revenue potential for a lab than one that performs only five.
Infectious disease assays
Commercial availability of FDA-approved molecular tests for infectious diseases accelerated community lab adoption of molecular testing. Previously, most molecular-based tests for bacterial and viral infections were developed by PhDs working in research and university laboratories. They were used within the institutions as an alternative to slow and laborious culture testing, which had been considered the gold standard for infectious disease testing, even though results took days or even weeks to report.
Today, molecular diagnostics is allowing clinical laboratories anywhere to accelerate infectious disease detection with greater precision. Culture testing has been supplanted by molecular methods for diagnosing viral diseases. PCR-based assays are used routinely to diagnose common respiratory infections such as RSV and influenza A and B.
Molecular diagnostics has also assumed a starring role in detecting, treating, and monitoring hepatitis C, a major public health priority identified by the U.S. Centers for Disease Control (CDC). CDC has taken to the airwaves, urging everyone in the Baby Boomer generation to get tested for hepatitis C to learn if they might have been infected some 30 years ago, before HCV testing became available.
Assuming significant numbers of Baby Boomers decide to get tested, the demand for HCV viral load monitoring is expected to rise and laboratories should brace for an increase in molecular testing volumes. With molecular tests now available on Main Street, doctors can conveniently monitor their patients on antiviral therapies, guide drug dosing, and identify resistant strains to prevent disease progression.
Cancer diagnostics
While HCV viral load testing is expected to increase molecular testing volume in community laboratories, perhaps the most visible and exciting application of molecular diagnostics is the rapidly growing field of personalized medicine for cancer care. Molecular diagnostics is the bedrock of personalized medicine, according to the Personalized Medicine Coalition, and it is hard to argue with that assertion. In recent years, personalized medicine has emerged as a viable treatment approach for cancer, as new treatments and companion diagnostic tests are available for lung cancer and melanoma, and the FDA has pledged that co-approval of drugs and diagnostics will occur more frequently in the future.
While companion diagnostics is proving to be the key growth driver for personalized medicine, it is allowing laboratories almost everywhere to be key partners in the clinical decision-making process.
Personalized medicine empowers clinical laboratories to be the central providers of patient-specific, actionable information to guide treatment decisions. Laboratorians are now clinical consultants expected to explain more than traditional lab results. Labs are assuming more prominent roles in oncology by assisting physicians with the interpretation of complex genetic test data, such as explaining the clinical significance of various tumor and pathogen genotypes and identifying patients for treatment with the expected steady stream of new gene-based therapies. For cancer patients, the “mainstreaming” of molecular diagnostics enables community hospitals to participate in the latest advances in cancer, reduce disparities with major cancer centers, and make state-of-the-art care available close to home.
Education for all stakeholders
The fourth driver is improved education in genetics and molecular testing for clinicians and laboratorians. Both in medical school and through continuing education courses, physicians are learning more about the genetic basis for various cancers and other diseases and how to apply this knowledge in clinical practice. Clinicians and laboratorians are learning about the ever-increasing role of companion diagnostics in cancer care. It is estimated today that there are more than 1,500 ongoing clinical trials for genetically targeted therapies, and many of the protocols require use of companion molecular tests to select appropriate trial subjects and monitor the efficacy of treatment.
Laboratory personnel are also learning about the business side of molecular diagnostics in sessions at major medical conferences, such as AACC and AMP. They are learning that trends in heathcare today favor adoption of molecular testing systems. They are also hearing that acquiring a molecular testing system can eliminate a significant and perhaps increasing volume of costly send-out tests. Lab directors should consider how molecular testing would fit into their current workload, help reduce outsourcing, and increase patient testing options.
Healthcare reform
Healthcare reform is also enhancing the role of molecular diagnostics in U.S. hospitals. The Affordable Care Act rewards hospitals for quality care and favorable patient outcomes. The law also penalizes hospitals with high readmission rates and other quality issues. The emergence of Accountable Care Organizations (ACOs) is shifting the focus of healthcare services to quality assurance. ACOs are groups of physicians, hospitals, and other providers that commit to offer coordinated, top-quality care for Medicare patients by ensuring timely, appropriate, high-quality medical service. (Note: there are commercial ACOs driven by plans for all patients, not just Medicare.)
When ACOs succeed in delivering on this commitment, they share in the savings realized by Medicare. One example is financial incentives for hospitals to prevent inpatient infections because Medicare and other insurers are unlikely to pay for care required to reverse a medical error or treat a hospital-acquired infection. Molecular testing can rapidly detect hospital-acquired infections and determine their susceptibility to antibiotic therapy. Molecular tests are also available to target the appropriateness of costly and life-saving therapies. They provide clinicians with sophisticated information not previously available to achieve desired outcomes.
What is the message for lab leaders who remain unsure whether adopting a molecular testing system is the right move? Certainly, they must consider their testing needs and availability of resources in the short and long term. More and more laboratorians, however, are reaching the conclusion that physicians and patients in their community deserve the benefits of state-of-the art medical diagnostics. In effect, they are hanging a new sign outside their “shop”: “Main Street Molecular—Open for Business.”
