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Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

FDA product code OIW · 4 cleared devices

Class 2 Clinical Toxicology
Regulation
21 CFR 862.3100
Review panel
TX
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2008-07-30 – 2018-03-15

This test is intended to measure the degree of similarity between the RNA expression pattern in a patient?s fresh-frozen tumor and the RNA expression patterns in a database of tumor samples for some common malignant tumor types that were diagnosed according to then current clinical and pathological practice. The test result is intended for use in the context of the patient?s clinical history and other diagnostic tests evaluated by a qualified clinician. The test is not intended to establish the origin of tumors (e.g. carcinoma of unknown primary) that cannot be diagnosed according to current clinical and pathological practice.

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