CEO SUMMARY: At Washington Hospital Center, it was unclear if the use of a rapid molecular assay for blood infections was changing outcomes until a new, real-time lab results reporting protocol required the lab to deliver the test results personally to the attending physician in real time. A study with a control group provided convincing
Molecular DiagnosticsSkip to articles
Molecular diagnostics is a technique used to analyze biological markers in an individual’s genetic code and how their cells express their genes as proteins, by applying molecular biology to medical testing. The technique is used to diagnose and monitor disease, detect risk, and decide which therapies will work best for individual patients.
These tests are useful in a range of medical specialties, including infectious disease — the largest driver of molecular diagnostics –- oncology, human leukocyte antigen typing (which investigates and predicts immune function), coagulation, and pharmacogenomics — the genetic prediction of which drugs will work best. They overlap with clinical chemistry (medical tests on bodily fluids).
By analyzing the specifics of the patient and their disease, molecular diagnostics offers the prospect of personalized medicine. Technological advances in diagnostics, particularly in the area of personalized medicine, are changing the structure of the diagnostics industry, according to a report by ARCA Biopharma Inc., a Colorado-based biopharmaceutical company. New technology is expanding applications and driving continued growth in the specialized testing market, the report says.
This has led to a shortage of medical technologists (MTs) and clinical laboratory scientists (CLSes). Hospital laboratories and pathology groups have been urged to take the increased competition for scarce medical laboratory workers as a signal that competition for MTs and CLSes from private sector companies will only increase in coming years. Pathologists and clinical laboratory managers will have to rethink the strategies their medical labs use to recruit, hire, and retain medical technologists and clinical laboratory scientists.
At the same time, pathologists and researchers foresee a huge development opportunity for biomarker-based molecular diagnostics in support of translational medicine. Rapid developments in that field – the practice of improving the health of individuals and the community through applying new knowledge into diagnostic tools including medical laboratory tests, medicines, procedures, policies, and education – include a role for pathologists who are discovering and validating molecular biomarkers associated with diseases.
CEO SUMMARY: As genomic medicine advances, researchers into various diseases quickly recognize the need to incorporate molecular pathologists onto their teams. In Grand Rapids, Michigan, a large integrated health system and a private research institute have come together to jointly fund a state-of-the-art molecular pathology laboratory. The twin goals are to advance research and create
CEO SUMMARY: In reporting on a suspected outbreak of whooping cough (Bordetella pertussis), a national newspaper suggested administrators at Dartmouth Hitchcock Medical Center had placed too much faith in molecular testing. In this exclusive interview, Dartmouth’s Director of Molecular Pathology comments on how the media misunderstood the story, and why molecular testing remains the preferred
CEO SUMMARY: Recent developments in breast cancer testing are leading to changes in pathology. Oncologists and pathologists have issued new guidelines regarding HER2 testing and new research suggests changes may be coming for estrogen-receptor testing as well. For the first time, the new guidelines require a certain level of testing and new procedures for pre-analytical
CEO SUMMARY: Doctors rely on labs for the definitive diagnosis of the bacterium that causes whooping cough. Yet in several recent cases, the use of a molecular test for a definitive diagnosis led to questions about the effectiveness of the test. Molecular pathologists recommend labs may need to do a second test to confirm initial
CEO SUMMARY: Pharmacogenomics, companion diagnostics, “personalized prescription drug therapy”—by any name, use of molecular diagnostics to guide clinicians in the prescribing and dosing of drugs is about to expand exponentially. Some experts predict that CYP450 testing alone will be a $1 billion business for labs in just a few years. Here’s a look at the forces driving this
HERE ARE THE TOP TEN MOLECULAR DIAGNOSTICS COMPANIES, ranked by revenues from international sales of clinical molecular products during 2004.
Collectively, these ten firms generated total revenues of $1.74 billion. By itself, Roche Diagnostics represents 40% of this market. One reason for this large number is the revenues generated by the PCR patents the company owns.
CEO SUMMARY: In the 15 years it has operated a molecular diagnostics testing program, Beaumont Reference Laboratory (BRL) has learned important lessons on how to evaluate which specific molecular assays are ready for clinical introduction. It has also learned effective ways to anticipate the clinical and financial success of such assays. Part II of this
CEO SUMMARY: It was about 15 years ago when William Beaumont Hospital and Beaumont Reference Laboratories first began offering molecular diagnostic testing services to clinicians. This successful effort came about because of effective strategic planning, use of consulting expertise at key junctures, and careful evaluation of the finances for each molecular assay added to the
CEO SUMMARY: Wall Street likes the potential of molecular diagnostics to infuse new revenues and operating profits into the laboratory industry. That is one reason Quest Diagnostics Incorporated and Laboratory Corporation of America are assertively seeking exclusive access to new molecular technologies. The latest such deal is Quest Diagnostics’ $42.8 million agreement with Ciphergen Biosystems.