# SeCore CDx HLA Sequencing System

Source: https://onco.cc/drugs/secore-cdx-hla/  
OnCo record `secore-cdx-hla` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The blood test that checks a person's tissue type (HLA-A*02) before tebentafusp for uveal melanoma or afamitresgene autoleucel for synovial sarcoma.

## Summary

One Lambda's SeCore CDx HLA Sequencing System is listed by the FDA as the companion diagnostic for tebentafusp in uveal melanoma, selecting HLA-A*02:01 (BR220737, 28 November 2022), and for afamitresgene autoleucel in synovial sarcoma (BK241074, 1 August 2024), where the eligible alleles are HLA-A*02:01, 02:02, 02:03 or 02:06 and HLA-A*02:05 excludes. One Lambda is a Thermo Fisher Scientific business.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: SeCore CDx HLA Sequencing System
- Modality: HLA sequencing companion diagnostic test (whole blood)
- Mechanism: Sequences the HLA-A gene from whole blood to find the tissue type that a T-cell receptor drug can recognise.
- Approvals: US 2022: Companion diagnostic for tebentafusp in uveal melanoma (HLA-A*02:01); US 2024: Companion diagnostic for afamitresgene autoleucel in synovial sarcoma (eligible HLA-A*02 alleles)

## Sources

- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools
- Thermo Fisher Scientific: One Lambda: https://www.thermofisher.com/onelambda/us/en/about-us.html

## Connected records

- drugs: [Afamitresgene autoleucel](https://onco.cc/drugs/afamitresgene-autoleucel/), [MAGE-A4 IHC 1F9 pharmDx](https://onco.cc/drugs/mage-a4-ihc-1f9-pharmdx/), [Tebentafusp](https://onco.cc/drugs/tebentafusp/)
- biomarkers: [HLA-A*02:01 (HLA typing for TCR therapies)](https://onco.cc/biomarkers/hla-a-02-01/)
- cancers: [Synovial sarcoma](https://onco.cc/cancers/synovial-sarcoma/), [Uveal melanoma](https://onco.cc/cancers/uveal-melanoma/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/)
- targets: [HLA-A](https://onco.cc/targets/hla-a/)
- companies: [One Lambda](https://onco.cc/companies/one-lambda/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Next-generation sequencing (NGS)](https://onco.cc/terms/ngs/)

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