![]() ![]() “There are different needs for infectious-disease testing, hematopathology, and genetics. She acknowledges, however, that automation may encourage centralization, while differing methods of testing may push for a decentralized architecture. “Our molecular diagnostics started out with a centralized architecture, but as the number of tests grew, it made more sense to group them into the disciplines,” Lyon says. Many labs have found that the lab starts out centralized, but becomes decentralized because of the wide variety of tests in all areas. Once the decision to bring molecular diagnostics in-house is made, a facility must determine whether the tests will be centralized in one molecular diagnostic lab or decentralized throughout all of the clinical labs. “For these tests, the volume is certainly there for most labs,” Hill adds. “Every clinical lab should at least use the FDA-cleared tests,” he says, citing those for chlamydia, gonorrhea, HIV, hepatitis C, and human papillomavirus (HPV). The question then becomes, ‘Should the lab offer molecular diagnostics even if they are outsourced?’ ” Proulx asks.Ĭraig Hill, PhD, manager of scientific affairs for Gen-Probe Inc in San Diego, thinks they should. “In some cases, the volume may not justify the expense. However, before bringing a test in-house, Proulx advocates considering the feasibility, cost, and appropriateness. The standard now for fragile X testing is the molecular assay,” she says. “The test used to be done by cytogenetics, but the sensitivity was low. “Molecular diagnostics should complement traditional testing and, when appropriate, can replace it,” says Elaine Lyon, PhD, chair of the Association for Molecular Pathology (AMP) clinical practice committee assistant professor at the University of Utah (Salt Lake City) and medical director of molecular genetics, ARUP Laboratories Inc in Salt Lake City. Now, with molecular methods, they need only collect cerebral spinal fluid, significantly changing the patient experience,” Proulx says. “Physicians wanting to test for herpes simplex encephalitis (HSE) used to have to do a brain biopsy to gather a sample. ![]() If not time, then molecular tests should provide some other advantage. “Real-time PCR can deliver a result in less than a day, versus 3 to 7 days for a viral culture or even longer for some targets,” he says. The sooner that information is delivered, the better. “The information a molecular assay can give to the physician can help to determine the diagnosis and course of treatment,” Proulx says. This might mean a faster turnaround or a less invasive sample collection, for example. “There is a strong interest in the marketplace for molecular diagnostics, and there are good examples of when it’s a better clinical practice than the current standard,” says Bob Proulx, VP of marketing for Nanogen Inc in San Diego. Before bringing molecular diagnostics in-house, clinical labs need to determine how they will deal with the variety of factors that will impact the success of the venture: value, architecture, testing menus and methods, automation, laboratory-developed assays, physician education, and reimbursement. ![]() It’s no wonder, then, that the field is one of the fastest-growing segments of in vitro diagnostics. ![]() Some of these tests have even been commercialized, automated, and made financially obtainable. Many established high clinical utility, and many others, such as genomics, continue to hold great promise. New molecular diagnostic methods became faster and less complex. Advances in processes and menus continued. Large academic and research hospitals began integrating molecular testing methods into their clinical labs. Some of the data yielded information with clinical relevance. Sequencing methods improved, and the genome was mapped. Its goals demanded improvements in testing methods, and researchers responded, surpassing the objectives with amazing speed. The information had vast potential, but it seemed there was a need for more to really obtain value.Įnter the human genome project. Until recently, molecular diagnostics methods were labor-intensive, expensive processes that required highly knowledgeable and expert scientists with specific experience. ![]()
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