Molecular Diagnostics
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.
New MoPath Lab Coalition Takes its Case to Congress
CEO SUMMARY: Prices recently established for molecular diagnostic tests are so low that they put patient access in jeopardy, declared a new lab industry coalition in a statement delivered to members of Congress. Called the Coalition to Strengthen the Future of Molecular Diagnosti…
Lab Companies’ IPOs Go Two-for-Three in November
CEO SUMMARY: This fall, a parade of molecular and genetic test companies moved forward with initial public offerings (IPOs) of their stock. In September, Foundation Medicine raised $106 million from its IPO. Encouraged by this success, three different companies proceeded with IPOs during …
Why One Molecular Diagnostics Company Closed Its Doors
CEO SUMMARY: When executives closed the doors of Pathwork Diagnostics last month, the simple explanation was that reimbursement for its proprietary molecular diagnostic test was inadequate. Indeed, that was part of the story. But other factors played significant roles in impeding…
Unprecedented Growth Rates for Molecular Testing
CEO SUMMARY: There will be an expanding role for innovative clinical labs as healthcare moves forward on its path toward personalized medicine. However, to capitalize on this opportunity, pathology groups and clinical labs will need to beef up their information systems. They will also nee…
Pathologists Can Offer ‘Companion Informatics’
CEO SUMMARY: Community hospitals are recognizing increased interest in personalized medicine among consumers. One expert predicts that this will create opportunities for hospital labs and pathology groups to add value by offering subspecialty expertise in molecular diagnostics, genetic te…
French Company Buys Pittsburgh-Based RedPath
CEO SUMMARY: Here’s a deal that is all about proprietary molecular assays and access to new markets. With its purchase of RedPath Integrated Pathology, ExonHit Therapeutics, S.A., of Paris, France, gains a CLIA laboratory and access to the U.S. market, even as the new owner ope…
Influenza A/H1N1 Outbreak Offers Lessons for Labs
CEO SUMMARY: As influenza A/H1N1 spread, clinical labs nationwide learned that they did not have the capacity to test for an outbreak of flu that generated a 10-fold increase in sample volume. To move the samples through the system, many clinical labs ran extra shifts and ran sho…
CDC, Public Health Labs Added Flu Test Capacity
CEO SUMMARY: Discovery of the A/H1N1 strain of influenza made it imperative that public health laboratories in the United States, Mexico, Canada, and other countries have more molecular testing capacity and capabilities in support of efforts to track and control the outbreak. App…
Molecular Advances Soon To Reshape Anatomic Path
CEO SUMMARY: Early this month, the second annual Molecular Summit assembled molecular first movers and early adopters to discuss their efforts to integrate molecular imaging and molecular diagnostics in patient care. One clear message emerged from two days of presentations and di…
Hospital Labs Have New Options for Molecular Dx
CEO SUMMARY: Laboratories that offer molecular assays continue to see strong growth in four areas: oncology, hematopathology, infectious diseases, and personalized medicine. Further, a new generation of molecular testing systems and analyzers is coming to market which will make it easier …
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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