In 1994 I coedited a book, Molecular Pathology: Approaches to Diagnosing Human Disease in the Clinical Laboratory, that coined the phrase "molecular pathology" to refer to applications of molecular biology in the traditional areas of laboratory medicine. That compilation of clinical molecular techniques included 11 chapters and an epilogue on "New Directions for the Clinical Laboratory." Chapter headings included: automation, neoplasia, heritable diseases, and infectious diseases.

Three years later, in 1997, Bill Coleman and Greg Tson-galis edited Molecular Diagnostics: For the Clinical Laboratorian, which contained 18 chapters and introduced the new areas of RT-PCR and In Situ PCR, and included a section on gene therapy. Now, ten years after the introduction of molecular pathology, we are looking at the second edition of Bill Coleman and Greg Tsongalis' text.

This second edition now comprises 44 chapters, and contains new chapters on bioinformatics, microarrays, methylation assays, FISH, laser capture microdissection, quality assurance, chimerism studies for bone marrow transplantation, and separate chapters on genetic counseling and ELSI (ethical, legal, and social issues). These new chapters represent developments in the past decade that have fundamentally changed the scope from molecular pathology to molecular diagnostics, highlighting the changing role of the clinical laboratorians who direct these efforts. It should be evident that molecular pathology and diagnostics impact almost every conceivable subspecialty in laboratory medicine and, particularly in the case of pharmacogenomics, have led to the development of new areas of investigation.

What is less evident is the burden placed upon the laboratorians directing these efforts. Issues regarding training, certification, continuing education, and reimbursement (just to name a few) have demanded enormous time and effort from professional organizations and governmental agencies. In addition, because conventional approaches cannot always be applied to molecular diagnostics, unique solutions for quality assurance and quality control must be developed. These challenges have engendered committees, subcommittees, taskforces, and workgroups from regulatory agencies and professional organizations, representing worldwide constituencies. As in any situation involving so many players, consensus-building and communication are mandatory. To these ends, professional journals and textbooks are our best hope for remaining current with this rapidly changing field. One needs only to compare the wealth of knowledge in this current edition with our efforts of only ten years ago to appreciate the magnitude of this challenge.

Lawrence M. Silverman, PhD

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