Home·Know Your Companions™·Tests·SeCore CDx HLA Sequencing System
FDA-approved companion diagnostic

SeCore CDx HLA Sequencing System

Sequencing-based HLA typing assay that identifies specific HLA alleles in genomic DNA to determine eligibility for HLA-restricted, T cell–based therapies.

IVD-developed CDxMethod: SangerSpecimen: Whole bloodBiomarker: HLA-A*02 and related class I alleles
Ready to order?

Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
BR220737
Supplements
Manufacturer
One Lambda, Inc. (ThermoFisher Scientific)
Approval date
November 28, 2022
Test specifications
Methodology
Sanger
Specimen
Whole blood
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
HLA-A*02 and related class I alleles
What this test is

SeCore CDx HLA Sequencing System is a sequencing-based HLA genotyping assay that amplifies and Sanger sequences defined HLA loci from genomic DNA. It provides high-resolution HLA allele calls to determine whether a patient carries eligible class I alleles required for certain HLA-restricted, T cell–directed therapies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Synovial sarcomaHLAEligible alleles: HLA-A*02:01, HLA-A*02:02, HLA-A*02:03 or HLA-A*02:06 and their P-group alleles. Exclusion alleles: HLA-A*02:05 and its P-group alleles.TECELRA
Uveal MelanomaHLAHLA-A*02:01KIMMTRAK

IVD Manufacturer

One Lambda, Inc. (ThermoFisher Scientific)

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Order this test

If your organization is connected to Casandra, you can place an electronic order forSeCore CDx HLA Sequencing System directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

© 2025 Casandra.ai

SeCore CDx HLA Sequencing System - CDxTests.com | CDx Tests