diaDexus PLAC test for heart disease
This article was originally published in The Gray Sheet
Executive Summary
Adjunctive, predictive laboratory test for congestive heart disease receives 510(k) clearance July 18. The blood test measures the level of the enzyme lipoprotein-associated phospholipase A2, which is created by macrophages when a person has CHD, FDA explains. "An elevated PLAC test result with an LDL-cholesterol level of less than 130 mg/dL gives doctors increased confidence that patients have two-to-three times the risk of having [CHD] when compared with patients having lower PLAC test results," according to the agency. The test was developed by San Francisco-based diaDexus and GlaxoSmithKline (1"The Gray Sheet" June 10, 2002, p. 8)...
You may also be interested in...
Test Would Assess Risk Of Cardiovascular Disease Using Enzyme’s Presence
diaDexus and GlaxoSmithKline are in the early stages of developing a joint diagnostic and therapeutic approach to treat patients by detecting and inhibiting an enzyme that may predict instances of cardiovascular disease
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.