Sep 10, 2014 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label
Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs.
UDIs also will apply to certain combinations of products that contain devices licensed under the Public Health Service Act (PHSA), such as donor screening assays and in vitro diagnostic (IVD) testing, including laboratory-developed tests (LDTs), noted a document describing the new law on the FDA website. (more…)
Oct 29, 2012 | Coding, Billing, and Collections, Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Uncategorized
Clinical laboratory professionals and pathologists should be aware of significant levels of errors in clinician gene test orders
Almost one-third of medical laboratory test orders for complex gene tests contained mistakes in handling by ordering clinicians. This finding comes from a study by ARUP Laboratories, Inc.. The finding is an early warning flag for pathologists and clinical laboratory professionals that a gap exists between the availability of genetic tests and clinician knowledge of how and when to use them and how to interpret the results. (more…)
Mar 31, 2010 | Laboratory News, Laboratory Pathology
Pathology labs would generally benefit if Judge Sweet’s ruling is upheld on appeal
It was positive news for many clinical pathology laboratories when a judge ruled against Myriad Genetics and the University of Utah Research Foundation in the federal suit attacking its patents for the BRCA1 and BRCA2 genes. The suit was brought by a group of patients, medical organizations and the American Civil Liberties Union (ACLU).
In Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office 09-civ-4515, pathologist groups, patient advocacy groups, and the American Civil Liberties Union (ACLU) are challenging patents for the BRCA I and BRCA II genes which are held by the University of Utah and licensed exclusively to Myriad Genetics, Inc., (NASDAQ:MYGN) of Salt Lake City, Utah.
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Feb 12, 2010 | Laboratory News, Laboratory Pathology, Uncategorized
Court case will directly affect future development of new pathology and molecular tests
In New York’s Southern District Court, a trial is underway that tests the legality of patenting genes. In Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office 09-civ-4515, pathologist groups, patient advocacy groups, and the American Civil Liberties Union (ACLU) are challenging patents for the BRCA I and BRCA II genes which are held by the University of Utah and licensed exclusively to Myriad Genetics, Inc., of Salt Lake City, Utah.
Many experts believe this lawsuit has the potential to produce new case law that addresses the ability of individuals and companies to hold patents on human genes. A ruling in favor of either party in the lawsuit will directly affect the clinical laboratory testing industry and diagnostic tests that utilize gene-based technologies.
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