TAG:
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.
Exome Sequencing Next “Big Thing” for Diagnosis
CEO SUMMARY: For disease diagnostics, exome sequencing is not yet routine, but geneticists are getting close. Using this technology, researchers read those parts of the human genome where about 85% of disease-causing mutations reside. By looking only at the regions that encode proteins—…
Roche Offers $5.7 Billion To Acquire Illumina Inc.
CEO SUMMARY: Once again, Roche is hunting for gene sequencing and gene analysis technology that can support its goal of being a world leader in gene-based therapeutics and clinical lab testing that utilizes gene tests and molecular diagnostics. Last week, Roche launched a hostile stock te…
ACLA Has its Say Regarding Molecular Dx Proposals
CEO SUMMARY: It is not known how many public comments have been submitted to Palmetto GBA, the big Medicare carrier, in response to its published proposals to change how code stacked claims for genetic and molecular tests will be handled, effective February 27, 2012, for labs in Medicare …
Palmetto GBA Announces Molecular Test Registry
CEO SUMMARY: Palmetto GBA, the nation’s largest Medicare Administrative Contractor (MAC), is asking labs in the J1 jurisdiction to submit applications for each molecular test they run. Molecular assays will receive a unique five-digit alpha-numeric identifier (Z-code) that will be enter…
Palmetto Execs Explain Molecular Test Policies
CEO SUMMARY: To create more transparency in the process clinical labs use to submit claims for genetic tests, molecular diagnostic tests, and for laboratory-developed tests (LDT), the nation’s largest Medicare Administrative Contractor (MAC) has proposed two new local coverage determina…
Economics of Lab Testing to Be Challenged
BY ANY MEASURE, 2012 IS SHAPING UP TO BE A YEAR OF MAJOR CHANGE for healthcare and the clinical laboratory testing industry. Unfortunately, an early reading of the tea leaves indicates that the outcomes are not likely to be favorable for most clinical laboratories and anatomic pathology groups. Let…
Medicare Carrier Plans to Reject Molecular Claims
CEO SUMMARY: In September, Palmetto, a Medicare carrier serving California and seven other states, made public two draft local coverage determinations (LCDs) that revamp its coverage guidelines for molecular diagnostic tests (MDT) and laboratory-developed tests (LDT). All labs su…
Rosetta Genetics, Aureon Biosciences, Plus Diagnostics, Atherotech, Sequenom
ROSETTA GENOMICS TO LAY OFF 35 EMPLOYEES TO CUT EXPENSES AND SHIFT MORE FUNDING toward sales of its proprietary molecular tests, Rosetta Genomics says it will eliminate 35 jobs. The company, based in Israel, operates a clinical laboratory in Philadelphia, Pe…
How Digital Pathology Helps Pathologists Deliver Added Value
“Pathologists have the opportunity to take on a new clinical role as the integrator of all that digital pathology information, in combination with the patient’s other clinical data collected from a wide variety of sources.” —Dirk G. Soenksen, M.S., M.B.A., Founder…
September 6, 2011 “Intelligence: Late Breaking Lab News”
Cleveland Heart Lab closed on a Series B financing round that totals $18.4 million. The money was provided by Excel Venture Management, Healthcare Ventures, and existing investors. Executives at Cleve- land Heart Lab said the new funds will be used t…
CURRENT ISSUE
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.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.