† The PCR process is covered by patents owned by Roche Molecular Systems, Inc.,
and F. Hoffman-La Roche, Ltd.
* All trademarks are property of their respective owners.
Beckman Coulter, the stylized logo and QuickLane are registered trademarks of Beckman Coulter, Inc.
Regulated Services
Regulatory Compliance
Across the breadth of Beckman Coulter Genomics’ service portfolio, we provide support for all levels of regulatory compliance. Beckman Coulter Genomics operates facilities capable of generating the highest quality data in support of clinical trials and clinical diagnostics. Our facilities use a quality program that incorporates components of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP). We also provide clinical diagnostic services that are compliant with the Clinical Laboratory Improvement Amendments (CLIA) regulations. Services are developed and provided based on client and regulatory requirements within the framework of the platform and project needs.
Sequencing
Gene Expression
| Service | Research |
Regulated |
CLIA |
|---|---|---|---|
| Standard Microarray |  |
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| Custom Microarray | |
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| MicroRNA Microarray | |
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| Expression qPCR | |
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| cDNA and Small RNA Sequencing | |
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Genotyping
| Service | Research |
Regulated |
CLIA |
|---|---|---|---|
| Whole Genome Analysis | |
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| Targeted Genotyping | |
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| Clinical Genotyping | |
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Biologics Testing
| Service | Research |
Regulated |
CLIA |
|---|---|---|---|
| Cell Bank Characterization | |
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| Biodistribution Testing | |
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| Residual DNA Testing | |
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| Custom qPCR Solutions | |
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Other Services
| Service | Research |
Regulated |
CLIA |
|---|---|---|---|
| Nucleic Acid Extraction | |
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| Biorepository | |
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Regulatory services are designed to support both preclinical and clinical needs, with full adherence to relevant regulations and guidelines including CFR Title 21 Part 58 for GLP, CFR Title 21 Parts 210 and 211 for GMP, and CFR Title 21 Part 50 and ICH E6 for GCP. CLIA services meet the needs of physicians who wish to order pharmacogenetic tests to aid in medical treatment. Tests can be developed, validated, and offered through Beckman Coulter Genomics. The hallmarks of Beckman Coulter Genomics’ various service levels include:
Research
- Suitable for everyday applications
- Performed under documented procedures
Regulatory (relevant GCPs, GLPs, and/or GMPs)
Required for client regulatory submissions
- Performed under applicable regulatory requirements (GCP/ICH, GLP, GMP)
- Voluntary hosting of >100 customer audits to ensure quality of services
- Experience completing >550 genotyping clinical trial projects
- Experience completing >1,500 sequencing clinical trial projects
CLIA Diagnostics
Required when test results are returned to Physician or Patients (Direct-Access testing) for use in medical treatment or dosing decisions
- Performed in CLIA-certified facilities (non-waived, high complexity)
- Beckman Coulter Genomics has more than 8 years in CLIA testing experience
