From 2004 to 2008, molecular diagnostics — the fastest growing segment in the U.S. clinical lab-testing market — grew 92% to become worth $5 billion in revenue, nearly one-tenth of the total diagnostics marketplace. In 2010, lab administrators seeking ways to increase test volume and revenue are considering establishing or growing a molecular diagnostics lab. Senior VP of Diagnostic Laboratories Ilke Panzer and her team of 140 scientists, physicians, and laboratorians at BloodCenter of Wisconsin deliver testing services in a set of esoteric referral labs specialized in transplantation, transfusion medicine, benign hematology, oncology, and genetics for its customers: physicians and hospitals nationwide, reference labs, and biotech and medical-device companies. Here, she covers key considerations for a lab that wants to add molecular testing to its operation.
MLO: Some observers say molecular testing is the next diagnostics “breakthrough.” Do you agree? If so, why?
Panzer: I agree. We hear so much about the promise of “personalized medicine,” and understanding a patient's genetic make-up may be an indicator of an individual's health predisposition. Identifying genetic makeup can help predict the likelihood of developing a future disorder. It can lead to earlier therapeutic intervention and more effective monitoring. And these understandings can result in personalized, targeted therapies, and immunizations that best match the patient's needs. We are still early in the evolution of the molecular-diagnostics field. On the business front, as the speed and capabilities of molecular diagnostics increase exponentially, cost per test may decrease. Clinical applications will increase as the value of these tests in changing patient outcomes is demonstrated.
MLO: What is the medical value of molecular diagnostics?
Panzer: One example of personalized treatment based on a patient's genetic make-up is warfarin genotyping, which may help clinicians dose this blood thinner more accurately and rapidly than previously possible. There are cases where genotyping, in conjunction with clinical data, has helped stabilize the dose faster, but this is not always the case. Adoption for this is still slow; but, as with many molecular tests, more value may be demonstrated over time. In cancer, molecular testing can monitor the effectiveness of a treatment, such as BCR-ABL testing to monitor drug therapy for leukemia, and can serve as an important diagnostic tool for breast cancer using BRCA1 and BRCA2. We can use HIV markers to identify infectious diseases. We can confirm phenotypic data, which increases diagnostic confidence. Molecular diagnostics allows testing when phenotyping reagents are not available; provides for more accurate donor matching in transplantation; and enables classification of disease, carrier testing, and prenatal diagnosis.
MLO: How did your organization enter the field of molecular diagnostics, and how has it evolved since?
Panzer: As an esoteric lab grounded in medicine and science, many of the tests on our menu originated in our basic research and product-development labs. An early example goes back to 1981, when an investigator at our Blood Research Institute recommended DNA testing for HLA. Our 1984 recruitment of an expert researcher led to molecular assays in histocompatibility for bone-marrow testing. Two years later, when the National Marrow Donor Program was established, it awarded us the contract for typing. We performed the first DNA testing to identify the bone-marrow transplant donor for a child with bare lymphocyte syndrome. In 2008, we opened the Molecular Oncology Laboratory to create new tests for several blood-related cancers to support the diagnosis and prognosis of leukemia. It is an extension of our existing Molecular Diagnostics Laboratory, which has found success in a wide range of molecular testing related to hematological disorders since 1996. The Molecular Oncology Laboratory has its own medical director and a budget for medical lab scientists and equipment. In 2010, the fastest growing test in our labs is an advanced molecular oncology test important in acute myeloid leukemia.
MLO: What does a lab need to know right now to engage in molecular diagnostics?
Panzer: Develop a strategic plan for selecting the initial and follow-on menus of assays. The lab should consider its current niche and technologies so that new tests can complement these offerings. It is helpful — perhaps essential — to align the menu selection with an organization's passion; at least, that is the best place to start. Acquire the appropriate instruments for amplification and sequencing are mandatory, but molecular diagnostics also requires in-house expertise to interpret results and consult with clinicians. This is a critical, as is a sales/marketing strategy to promote new assays and increase volume. The long-range plan must include sufficient budget to invest in new technologies to stay current with the rapidly evolving science and competitive in the marketplace. A lab must be aware of and account for CAP guidance and CLIA regulations that deal specifically with molecular testing. Inevitably, labs must stay current when these groups update regulations/recommendations as the field matures.
MLO: How can lab personnel persuade management to add molecular testing to enhance their offerings?
Panzer: The most persuasive arguments surround customer service and profitability. By adding molecular assays, a lab can conduct more testing with current clients, add new clients in its current areas of service, and offer new areas of service. Molecular diagnostics can increase volume and revenues, protect current business, and improve profitability. Another approach is to ask what is at risk by not doing molecular testing. Will your lab become obsolete? Will you be unable to meet the needs of your customers? Will you lose key talent to those labs that do offer molecular diagnostics? Ultimately, lab personnel must make their case by defining objectives, quantifying current strengths, analyzing market opportunity and attendant start-up costs, and projecting short- and long-term revenue and profitability. If these exercises are approached with passion and rigor, lab personnel should be able to make a compelling case for molecular diagnostics having a positive impact on the bottom line.
