Evaluation of Pathwork Tissue of Origin (TOO) Test for Human Malignancies

Inclusion Criteria:

1 Subjects must be at least 18 years old. The TOO test is designed to
determine the tissue of origin of common adult malignancies. There are no gender/ethnic
restrictions.

2 Patients with a diagnosis of malignancy established by pathologic review of H&E
staining of tumor biopsy or tumor resection without definitive determination of tissue of
origin as assessed by the PI. Samples must have been obtained within three months of
enrollment, or the patient must still be under active evaluation for tissue of origin at
the time of enrollment. There are no limitations on prior therapy and time from last
prior therapy.

3 Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:1 Patients under the age of 18 are excluded. There are no exclusions
based on gender/ethnicity.

2 There are no exclusion requirements due to co-morbid disease or incurrent illness, as
needed.

3 Pregnancy or nursing participants will not be excluded from the study.

4 Patients with a diagnosis of leukemia including acute myelogenous leukemia, acute
lymphocytic leukemia, hairy cell leukemia, chronic myelogenous leukemia and chronic
lymphocytic leukemia are excluded from enrollment on this study. The TOO test does not
cover these diagnoses.