One Lambda One Lambda™ | Product Documentation & Support
Order Status Order Status Login | Register | Log Out
Search
clear search
Recent searches Clear History
Suggestions
All Results
Search

SeCore CDx HLA A Locus Sequencing Kit

The First HLA typing companion diagnostic granted de novo classification by FDA

One Test That Can Expedite Treatment Selection Decisions

Uveal melanoma is rare but often has a high tendency to metastasize, which results in high mortality. SeCore™ CDx HLA A Locus Sequencing System is the first high-resolution HLA Typing companion diagnostic granted de novo classification by the FDA to aid in the selection of HLA A*02:01-positive patients with uveal melanoma that cannot be removed by surgery or has spread and who may benefit from treatment with KIMMTRAK® (tebentafusp-tebn) when used in accordance with approved therapeutic labeling.


SeCore CDx HLA A Locus Sequencing Kit

The SeCore CDx HLA Sequencing System can be used to identify and define human leukocyte antigen A-locus (HLA A) alleles using genomic DNA isolated from whole blood samples. The device is intended to be used as a companion diagnostic (CDx) to aid in the selection of HLA A*02:01 patients with unresectable or metastatic uveal melanoma who may benefit from treatment with KIMMTRAK when used in accordance with approved therapeutic labeling.


SeCore CDx HLA GSSP Kit

The SeCore™ Group Specific Sequencing Primer (GSSP) kits target a DNA haplotype to resolve cis/trans (phase) ambiguous allele pairs. Cis/trans ambiguous allele pairs arise from standard Sanger typing. The GSSP binds to only one of the two alleles present in the DNA sample to aid in the determination of the final HLA typing.


uTYPE CDx HLA Sequence Analysis Software

The uTYPE™ CDx HLA Sequence Analysis Software processes DNA sample data files generated from the SeCore CDx HLA A Locus Sequencing and SeCore CDx HLA GSSP Kits. The detected HLA alleles are analyzed and assigned by comparison to the IMGT/HLA database.

The uTYPE HLA Sequence Analysis Software combines rapid data analysis with effective results management.

  • Interpret data from a single user interface and navigate easily through key positions.
  • Utilize single-click editing without compromising your original data file.
  • A unique filter function eliminates mismatched allele combinations from consideration, while customizable reports containing interpreted results are available for convenient review.

Ask about Our HLA Typing Assays for Companion Diagnostics

SeCore CDx HLA A Locus
Sequencing Kit

CAT#: SECCDX-A

Sanger sequencing assay for identification and definition of HLA-A*02:01 allele(s) and to aid patient selections for the indicated therapies.

SeCore CDx HLA GSSP Kit

CAT#: SECCDX-GSSP

Group Specific Sequencing Primers for resolving ambiguous allele combinations from DNA generated by SeCore™ CDx HLA A Locus Sequencing Kit.

uTYPE CDx HLA Sequence Analysis Software

CAT#: UTPCDX-PGR

Used for analysis of sequencing data to determine molecular typing by comparison to the IMGT/HLA database. 

Interested in CDx
Co-Development?

Ask About Our HLA Typing Solutions for Companion Diagnostic Development

We have established processes and experience for all aspects of CDx co-development needs that involve coordinated efforts with pharmaceutical partners, contract research organizations (CROs), and regulatory bodies. Capabilities include full HLA typing service laboratories that combine our in-depth scientific knowledge and high-quality regulatory-compliant operations as well as a suite of high-quality products that can accelerate workflow from discovery to clinical trial to regulatory submission.