Mar 28, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Federal agency hopes its open-source precisionFDA web portal will aid in development of laboratory-developed tests and inform regulatory decision-making
One recent initiative launched by the Food and Drug Administration (FDA) to foster the greater sharing of genetic information may be of some value to pathologists and clinical laboratory scientists who are developing laboratory-developed tests (LDTs) that incorporate molecular and genetic technologies.
The FDA unveiled an open-source platform for community sharing of genetic information. It is called precisionFDA, and the FDA describes its new web platform as an “online, cloud-based portal that will allow scientist from industry, academia, government, and other partners to come together to foster innovation and develop the science” of next-generation DNA sequencing processing. (more…)
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…)
Mar 5, 2014 | Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Pathology groups and clinical laboratories are among the beneficiaries if the Accelerating Medicines Partnership achieves its goals
Power players in healthcare are about to invest nearly a quarter of a billion dollars to accelerate the time it takes for new medical discoveries to gain regulatory approval and enter clinical use. The emphasis will be on both therapeutic drugs and diagnostics, making this an important development for in vitro diagnostics companies and medical laboratories.
Anchors to this new initiative are the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Their partners are 10 pharmaceutical companies and six nonprofit groups. The goal is to jumpstart research to find targets for new drugs and diagnostics, noted a Genomeweb.com article. (more…)
Sep 18, 2013 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Family of Henrietta Lacks, who died in 1951, will have a say in the research use of the HeLA cancer cells
Patient privacy rights involving genetic information has gone to a new level. Pathologists and clinical laboratory managers will want to understand the legal precedents and new standards established in an unprecedented agreement between the family of a woman who died in 1951 and the growing research establishment studying her cervical cancer cells following her death.
It is a human interest story that attracted global media attention this summer. The immortal cancer cells of Henrietta Lacks—known in research laboratories as “HeLA” cells—are finally coming under legal protection after more than 60 years of travelling the globe.
It was 1951 when Lacks died of an aggressive form of cervical cancer, but her cancer cells were grown without consent of relatives and have been used worldwide in cancer research since her death. Lacks’ living relatives sought and recently obtained a legal agreement with the National Institutes of Health (NIH) to protect their DNA privacy, according to a story published in USA Today. (more…)
Mar 21, 2011 | Laboratory Operations, Laboratory Pathology
Celera is not a medical laboratory, but develops biomarkers and molecular diagnostics tests
For the second time since the New Year, Quest Diagnostics Incorporated (NYSE:DGX) has announced an acquisition. Last Friday, Quest Diagnostics said it had agreed to purchase Celera Corp. (NASDAQ:CRA) for a purchase price that Reuters reported to be $657 million.
What makes this acquisition different from those typically done by Quest Diagnostics and its major competitor, Laboratory Corporation of America (NYSE:LH), is that Celera is primarily not a provider of clinical laboratory tests. Rather, it specializes in identifying biomarkers that can be used to develop genetic tests. It is active in the fields of cardiovascular diseases, cancers and neurological disorders. Berkeley HeartLab is one clinical laboratory testing division owned by Celera.
(more…)
