FDA’s New Next-Generation DNA Sequencing Platform Intended to Increase Collaboration among Scientists, Pathologists, and Clinical Laboratory Experts

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...

FDA’s Unique Device Identifier Program for In Vitro Diagnostic Devices Used by Clinical Laboratories Set to Begin September 24

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...

National Institutes of Health Creates Partnership with Big Pharma to Improve Development Success of New Drugs and Diagnostics and Speed FDA Clearance

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....

Agreement on Use of Genetic Information from 61-Year-Old Cervical Cancer Cells Sets New Ethical Privacy Standards for Clinical Pathology Laboratories

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...

Clinical Laboratory Company Quest Diagnostics Agrees to Acquire Celera Corp. for $657 Million

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...
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