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Elevate your projects with precision medicine insights
Explore the forefront of medicine with our precision insights and specialty laboratory services. Our advanced diagnostic and molecular testing services offer exceptional support for academia, pharma, and biopharma. Utilizing innovative assays, profiling, and biomarker analysis, we empower customers to unlock new possibilities in disease research and product development.
Our advanced testing capabilities can help accelerate your project. Partner with us to leverage the power of our testing services, elevating your work in researching complex diseases.
Comprehensive HLA typing services beyond transplantation
HLA typing services, traditionally vital for transplantation, can also play a crucial role in other indications. Our advanced HLA typing capabilities can help enable biomarker research for precision medicine applications. Additionally, our capabilities can support research in areas such as oncology and neurological disorders like narcolepsy. Partner with us to leverage our comprehensive HLA typing services and help advance precision medicine initiatives. Our key services include:
HLA typing services
Our intermediate and high-resolution assays support all stages of CDx co-development and regulatory compliance, as well as providing HLA typing for clinical trials and cell therapy studies.
| Thermo Fisher Scientific HLA NGS service | Thermo Fisher Scientific SeCore HLA Sanger Sequencing service |
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|---|---|---|
| Technology | Next Generation Sequencing |
Sanger Sequencing |
| Turnaround time | Results in about 3-5 days |
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| Results | High-resolution results |
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| Coverage | Class l and ll HLA Full gene coverage 11 HLA Loci. Coverage includes:
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HLA Class I and Class II |
LABScreen antibody detection testing + extended panel (ExPlex Panel)
- Rapid turnaround: HLA antibody detection testing with a 2-day turnaround time
- Extended analysis: Includes an additional 54 Class I and 24 Class II single antigens for a deeper analysis of donor-specific antibodies
dd-cfDNA assay
- Next-generation sensitivity: A highly sensitive, next-generation sequencing (NGS) assay capable of detecting donor-derived cell-free DNA at levels as low as 0.1%.
MMDx (Molecular Microscope Diagnostic System)
- Detailed molecular profiling: Utilizes heart, lung, or kidney biopsy tissue preserved in RNAlater to provide a detailed molecular profile of the transplanted organ. This test can support the assessment of subclinical immune-mediated injury (ABMR), injury, and T cell-mediated rejection (TCMR).
CXCL10 urine biomarker testing
- Non-invasive monitoring: Urine-based biomarker to evaluate for early onset inflammation in the transplanted kidney.
Whether you're a clinical lab, transplant center, biotech company, or any other organization developing novel therapeutics, our team is here to support your diagnostic and co-development needs with precision and reliability.
Learn more about our sites and how we can help
Companion diagnostics are tests that are developed and used in conjunction with specific therapeutics to identify patients who are most likely to benefit from the treatment or to monitor their response to the therapy. The use of biological markers to pinpoint patients who will benefit from specific therapies has greatly sped up drug development and approval. However, this advancement has also complicated the process by requiring the simultaneous development of companion diagnostic (CDx) assays to accurately identify these patients. Our team offers specialized scientific experience to enable the success of your CDx development and to accelerate your pipeline progress.
Fishers, Indiana
Snapshot: State-of-the-art, Clinical Laboratory Improvement Amendments (CLIA) certified lab focused on improving patient outcomes with noninvasive transplant diagnostic testing, including urine-based assays to monitor transplant recipients for organ rejection risks and other complications, thereby expanding access to post-transplant monitoring and advanced diagnostics. |
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West Hills, California
Snapshot: Advanced in vitro diagnostic medical device manufacturing site focused on HLA detection including the first companion diagnostic device cleared for HLA allele detection.
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The SeCore CDx HLA Sequencing System has been cleared for in vitro diagnostic use in the United States. Not available in all countries.
Not all products are CE marked or have 51O(k) clearance for sale in the U.S. Availability of products in each country depends on local regulatory marketing authorization status.
Some products and services are Laboratory Developed Tests (LDTs) offered, developed and validated through One Lambda Laboratories. These LDTs are used for clinical purposes by the CLIA certified laboratory performing the test. These tests have not been cleared or approved by the FDA or CE marked in the EU as in vitro diagnostic tests.
MMDx Heart and MMDx Kidney are tests that were developed and validated by Kashi Clinical Laboratories, Inc. The laboratory developed tests are used for clinical purposes by the CLIA-certified laboratory performing the test. These tests have not been cleared or approved by the US FDA or CE marked in the EU as an in vitro diagnostic test.
MMDx and Molecular Microscope are trademarks of Transcriptome Sciences Inc.