US · guidance
CMS Pub. 100-03, ch. 1, § 190.7
Human Tumor Stem Cell Drug Sensitivity Assays
CIM 50-41
Human tumor stem cell drug sensitivity assays involve exposure of human tumor stem
cell colonies grown in tissue culture to anticancer drugs and observing for cytotoxic
effects. Their purpose is to screen potential anticancer drugs and predict the effects of
these drugs on tumors of individual patients, to allow the selection of the most effective
drug or drugs for that patient. Human tumor drug sensitivity assays are considered
experimental, and therefore, not covered under Medicare at this time.
The Fluorescent Cytoprint Assay, a miniaturized organ culture system for cancer
chemosensitivity testing, allows for qualitative visual estimation of cell kill using low
power microscopy and a noncytotoxic fluoresence probe for cell viability. The clinical
application of the assay, based on testing in tumor microorgans rather than in clones
derived from single cells, is considered experimental, and therefore, not covered under
Medicare at this time.
History
(Rev. 1, 10-03-03)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
604b016f6076462ca8db079d1f7eabdc6e0b17e2a25adaee001d7809ca9a8784
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