Apr 21, 2023 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Testing, Pathology and Clinical Laboratory Conferences
The VALID Act has been refiled and the FDA has declared its intent to issue a proposed rule to enable it to oversee LDTs Should the federal Food and Drug Administration (FDA) have the authority to regulate laboratory-developed tests (LDT)? Advocates in favor of this outcome are working to make FDA oversight of LDTs a reality. On March 29, HR.2369—the Verifying Accurate Leading-edge IVCT Development Act of 2023 (VALID Act)—was refiled in the US House of Representatives by Representatives Larry...
Jul 11, 2012 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, News From Dark Daily
Both pathology profession and biotech industry have much at stake in how Supreme Court rules in this important case involving the patentability of genes Legal challenges to gene patents are a high interest topic among pathologists and clinical laboratory scientists who perform genetic testing. Two high profile cases involving gene patents were accepted by the Supreme Court. A ruling was made in one case and the second case is continuing. The Supreme Court issued a ruling in one case, titled...
Jul 13, 2011 | Laboratory News, Laboratory Pathology
Nestlé says its Prometheus Laboratory acquisition will help it develop products for patients with metabolic conditions and to promote brain health When it comes to the brave new world of genetics in pathology and clinical laboratory testing, such terms as pharmacogenomics, companion diagnostics, and personalized medicine have been coined to describe the intersection of genetic testing and molecular diagnostics with emerging medical practice. Now the world’s largest food company is putting...
