Bartels Prognostics' ChemoResponse 5-FU assay is approvable, FDA panel concludes.
This article was originally published in The Gray Sheet
Executive SummaryBARTELS PROGNOSTICS' PMA FOR CHEMORESPONSE ASSAY FOR 5-FU RESISTANCE needs additional information regarding the reproducibility of test results before receiving approval, FDA's Microbiology Devices Panel concluded at a May 1 meeting in Gaithersburg, Maryland. The stipulation regarding reproducibility data was one of several conditions the panel placed on a unanimous thumbs-up recommendation for the ChemoResponse premarket approval application. The microwell assay is designed to help determine whether metastatic breast cancer patients who have failed other therapies are likely to be resistant to continuous infusion treatment with 5-fluorouracil.
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