Evaluation of ClearLLab Leukemia and Lymphoma Panels

Multi-center study of specimens from subjects presenting for flow cytometry immunophenotyping
as part of their standard of care for hematological diseases work-up. Residual specimens will
be tested using the ClearLLab Panels to determine the presence or absence of an abnormal
phenotype and compare results to clinical impression (hematological malignancy or
non-malignancy).

Inclusion Criteria:

- Residual samples from patients with hematological abnormalities being evaluated by
Flow Cytometry for the presence or absence of an abnormal population associated with a
hematological malignancy. All subjects of any ethnicity, age and racial background
will be included.

Exclusion Criteria:

- Specimens and/or spent samples that are visibly hemolyzed

- Specimens and/or spent samples that are visibly clotted

- Specimens and/or spent samples collected in K2EDTA anticoagulant older than 24 hours
from time of collection

- Specimens and/or spent samples collected in Heparin or ACD anticoagulant older than 48
hours from time of collection

- Samples with insufficient volume to complete the protocol tests