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.
For Molecular Tests, Evaluate All Factors
CEO SUMMARY: When this hospital lab adopted molecular screening tests for Chlamydia trachomatis and Neisseria gonorrhoaea, physicians soon noticed a change in the rate of false positives. In researching the performance of the molecular assays compared to cultures, pathologists at this lab…
Evolution in Pap Marketplace Shows Impact of New Guidelines
NEW GUIDELINES for cervical cancer screening issued last year are fueling strong growth in the sales of Digene Corporation’s HPV test. For its fiscal second quarter that ended on December 31, 2004, Digene reported sales of $27.0 million. That’s a 28% increase from Digene’s sal…
Roche/Affymetrix Microarray Cleared for Clinical Use by FDA
MOLECULAR DIAGNOSTICS took a big step forward in December. During the month, the Food and Drug Administration (FDA) cleared the first microarray instrument system and microarray-based laboratory test for clinical use. The FDA announced on December 23, 2004 that it had cleared the Ge…
Going, Going, Soon Gone: MDS Pulling Out of U.S.
CEO SUMMARY: Even as the best of its lab testing joint ventures with hospitals and health systems prove profitable, MDS Diagnostic Services is taking active steps to resolve its participation as a partner. In a candid interview, its President and CEO acknowledged the best attributes of su…
Molecular Diagnostics’ “Gap in Expectations”
CEO SUMMARY: This year’s Executive War College provided strong evidence that the twin trends of molecular diagnostics and Lean management methods are taking root within the laboratory industry. Each is a trend in its infancy. Molecular diagnostics will require considerable time before i…
Useful Info at War College On Molecular, Lean, et al
CEO SUMMARY: When the nation’s leading laboratory administrators and pathologists gather in New Orleans on April 27- 28, they will get the best and latest developments in laboratory management. From Aetna’s National Medical Director to the former Chief of the Industry Guidance Branch …
Offering Molecular Tests Has Surprises & Pitfalls
CEO SUMMARY: Laboratories that offer some of the new assays based on molecular technologies often find themselves facing significant financial risk. That’s because payers are skeptical about new lab tests which come at a high price, but don’t offer substantial clinical benefit. One ea…
RFP Secrets To Use When Buying Molecular Tests
CEO SUMMARY: It often takes two to four years before payer coverage and reimbursement become stable. During that time, NorDx Laboratories wants the vendors who sell it new molecular assays to have some “skin in the game.” It accomplishes this by negotiating contracts that link the con…
“State of Industry” Report On Molecular Diagnostics
CEO SUMMARY: Enterprise Analysis Corporation has launched an ambitious survey that will include 150 laboratories performing molecular testing in the United States. Last week it released information about the first 51 labs contacted in this effort. The survey provides an intriguing look at…
“Companion Diagnostics” Enter Lab Marketplace
CEO SUMMARY: Although the field of pharmacogenomics is still in its infancy, it has begun to develop sub-specialty areas. “Companion diagnostics” describes the marriage of a therapeutic drug with a specific diagnostic assay that can identify which patients will benefit from a prescrip…
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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