Standardized In Vitro
Diagnostic Cgmp Products
For Hematology-Oncology,
As Well As Ruo Assays

Analyte Specific Reagents (ASRs), And DNA & RNA Controls.

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.

Invivoscribe’s ABI Fluorescence Detection And Gel Detection Assay

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.


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.

Test Algorithm For Suspect Lymphoproliferations

By Euro Clonality And BIOMED-2 Group For PCR-Based Clonality
Assessment Of Suspected B- And T-Cell Lymphoproliferative Disorders.

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.

Contact Us


1801 Century Park East, 25th Floor, Century City, CA. 90067

424 – 307 – 4477


Mon-Fri: 9:00AM-5:00PM

Sat: Closed

Sun: Closed