The NY times recently published an article with a catchy headline: ‘F.D.A. Targets Inaccurate Medical Tests, Citing Dangers and Costs’. For those outside of the industry, it may appear that the FDA painted a picture of them riding in to save the day again, akin to Clint Eastwood in a wild west movie. The message from the NY […]
The cost of a false-negative in molecular diagnostics
$775,278 (apparently) False-negatives have the potential to greatly impact on patient care when a test results in a negative result, when the disease or condition is actually present. Since the FDA have been looking to control LDTs, new data has come out (courtesy of the FDA, funny that) showing their most recent document of 20 […]
How would the FDA bake a cake? By performance or design?
I cracked open a beer in preparation for the FDA’s (creatively named): “Public Workshop – Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests”. Oh great, I expected bordem, little did I know I was in for a treat! The Precision Medicine Movement Coined (?) by the charismatic Barack Obama […]
The accuracy of molecular diagnostic testing
In the era of personalized medicine, the accuracy of molecular diagnostic testing is more important now than ever. Personalized medicine, with the aid of molecular diagnostic testing, is providing the exciting possibility of cost-effective tailored therapies, based on an individual patient’s genetic code. This is particularly true in the case of cancer where a single […]
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