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Diagnostic tests
A diagnostic test is any kind of medical test performed to aid in the diagnosis or detection of disease. For example, such a test may be used to confirm that a person is free from disease, or to fully diagnose a disease, including to sub-classify it regarding severity and susceptibility to treatment. Diagnostic tests help physicians make clinical decisions for patient care.
Some diagnostic tests are parts of a physical examination that require only simple tools in the hands of a skilled practitioner, and can be performed in an office environment. Some other tests require elaborate equipment used by medical technologists in clinical laboratories, or the use of a sterile operating theater environment.
Some tests require samples of tissue or body fluids to be sent off to a pathology lab for further analysis. Some simple chemical tests, such as urine pH, can be measured directly in the doctor’s office.
The validity of such test results produced in each laboratory is entirely dependent on the measures employed before, during, and after each assay. Consistency in the production of good results requires an overall program that includes quality assurance, quality control, and quality assessment.
Diagnostic tests can be classified into three categories: invasive, minimally invasive and non-invasive.
Every test that shows an association between test results and the target disease is potentially useful. If it is not on its own thought to be useful, then a combination of it with other test results and/or data can potentially lead to a post-test probability that is thought to be high enough to rule the diagnosis in or low enough to rule the diagnosis out.
Companion diagnostics have also been developed to preselect patients for specific treatments based on their own biology, where such targeted therapy may hold promise in personalized treatment of diseases such as cancer.
Growing acceptance of companion diagnostics is a trend with the potential to greatly increase the value that clinical pathology laboratory testing delivers to physicians, patients, and payers. It has become increasingly common for pharmaceutical companies to make agreements with in vitro diagnostics (IVD) manufacturers to develop a companion diagnostic test specifically for a therapeutic drug under development by that pharmaceutical company.
As most pathologists and clinical managers know, use of a companion diagnostic test is expected to add precision to the physician’s decision to prescribe therapeutic drugs.
Bio-Rad Buys Ciphergen’s Proteomics Technology
PROTEOMICS IS EXPECTED TO BE ONE of the most active areas in molecular diagnostics and Bio-Rad Laboratories, Inc. has just staked a major claim to a promising proteomic technology. In a transaction announced on August 18, 2006, Bio-Rad will acquire the proprietary proteomics instrum…
CYP450 Testing To Have Major Clinical Impact
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 …
Luminex and PerkinElmer Ink Licensing Agreement
CEO SUMMARY: PerkinElmer’s interest in the multiplex capabilities of Luminex’s xMap technology led to this new licensing agreement. PerkinElmer’s instrument systems played a major role in accelerating the work of the Human Genome Project. Now, besides bioresearch applications, Perki…
Lab Integration At Geisinger Contributes to Better Outcomes
CEO SUMMARY: There have been two benefits from the use of sophisticated laboratory informatics at the laboratory division of Geisinger Health System in Danville, Pennsylvania. Benefit one is a standardized, fully-integrated lab information system that collects all lab test results, includ…
Lab Tests in Pharmacies, Genzyme, Healthe, Singing River Hospital, VA
IT IS OFTEN SUGGESTED that pharmacies are a logical place to combine laboratory testing with prescription services. Such an arrangement would be consumer-friendly and has the potential to improve patient care while lowering costs. In Great Britain, the National Health Service has launched a pilot pr…
Do Regional Laboratories Have A Bright Future?
IF INTEGRATED INFORMATICS CAPABILITIES will be a major point of differentiation among competing laboratories in the future, then several warning flags have recently appeared in the laboratory industry. Regional laboratories and hospital lab outreach programs should take notice. One warning flag is t…
Proteomic Tests Poised For Clinical Market
CEO SUMMARY: Proteomics-based technology is developing rapidly. The strategic collaboration announced last month between Ciphergen Biosystems and Quest Diagnostics Incorporated is potentially worth $25 million. It is an expensive bet that next-generation proteomics tests soon to enter the…
For Quest and LabCorp, The Story is “Molecular”
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 molecula…
Phlebotomist Gibson Steals Patient’s Identity
CEO SUMMARY: It was a case of a well-liked lab worker acting in rogue fashion to steal and use the identity of a patient to commit financial fraud. Within laboratories, employees in phlebotomy, accessioning, data entry, coding, billing, and collections often have access to sensitive patie…
“March 7, 2005 Intelligence: Late Breaking Lab News”
It was good news for the nine-year old boy with the rare brain tumor he named “Frankstein.” On midnight, Monday, February 14, 2005, the family received a telephone call from the surgeon who performed the biopsy on February 2, 2005. He confirmed that the biopsy was negative for cancer. What is int…
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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