Overview Of Top Of The Line Assays And Reagents.
Aleph Diagnostics continues to collaborate with Partners to review a full range of standardized in vitro diagnostic cGMP products for hematology-oncology, as well as RUO assays, analyte specific reagents (ASRs), and DNA & RNA controls.

A comprehensive selection of PCR-based assays for ABI fluorescence detection and gel detection, including targeted FLT3 ITD and TKD mutation assays, B- and T-cell clonality assays (based on Euro Clonality / BIOMED-2 Concerted Action BMH4-CT98-3936), and translocation assays.
Reviewed by an accredited Lab implementing internationally standardized testing of novel and proprietary bio markers that are critically important for patient care.
NGS Cancer Panels
Cytogenetic identification of chromosome abnormalities has become essential for the clinical management of patients with leukemia and is currently being used to help categorize patients into risk groups.
MRD NGS Tests
B- and T-cell MRD tests are NGS-based assays that can be used to detect clonal gene rearrangements identified at diagnosis within virtually all of the antigen receptor loci for both B- and T-cells. NPM1 MRD and FLT3 MRD tests are NGS-based assays that can be used to detect targeted mutations identified at diagnosis.

Gene Clonality Assays Overview
The Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal T-cell receptor delta chaingene rearrangements in patients with suspect lymphoproliferations and can be used to:
- – Identify clonality in suspect lymphoproliferations.
- – Support a differential diagnosis between reactive lesions and T-cell and some immature B-cell malignancies.
- – Determine lineage involvement in mature lymphoproliferative disorders.
- – Monitor and evaluate disease recurrence.
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ALEPH DIAGNOSTICS INC
1801 Century Park East, 25th Floor, Century City, CA. 90067
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