PARTNER WITH US!
Laboratory Service Partnerships
Comprehensive wet-lab and dry-lab multi-omics solutions for studies requiring a CLIA/CAP laboratory.
Expert laboratory support:
- LDT validation
- drug and assay development
- companion diagnostics
- targeted therapy programs
- novel treatment studies
In the United States and Internationally – whether multi-site collaborations or needs, the SeqMatic white-glove NGS omics sequencing services provide assurance of expert handling, tracking and coordination of precious samples.
Our clinical laboratory is registered with the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and is accredited by the College of American Pathologists (CAP).
Key Considerations
CRITICAL THINGS TO CONSIDER WHEN SELECTING A SERVICE PARTNER
Picking the right lab isn’t just a matter of convenience; you want to make sure it fits your exact needs and it aligns with your technical, regulatory, and operational process. A few details can make all the difference in your results.
- Choose flexibility for the extent of work needed; our services support LDT implementation in compliance with CMS, FDA, and CDC standards.
- Select wet or dry lab services or leverage end-to-end workflow services.
- Decide on your output, whether raw data or formal diagnostic reports.
SeqMatic has put together a technical and scientific guideline to highlight important elements to consider when you select a partner for your NGS assay validation. These Key Considerations are available for download as part of our exclusive content.
- Accreditation & Compliance
- Expertise & Technical Depth
- Technology, Infrastructure & Capabilities
- Global Logistics & Sample Management
- Turnaround Time & Operational Agility
- Sample Stewardship & Problem‑Solving
- Communication & Collaboration
- Data Security & Ownership
- Flexible Engagement Models
- BIOSECURE Act Compliance
Validation Process
OUR VALIDATION PROCESS - LDT ASSAYS
> We assign a multidisciplinary team responsible for planning and executing the validation study
> We onboard your NGS assay, train the SeqMatic CLIA team, develop a proficiency template, and perform workflow optimization. Goal is to prove that we get the same (or better) results in our lab versus yours!
We add your assay to the SeqMatic LIMS for sample tracking and reporting
Review and approval of the validation plan by our Medical Director
All key equipment used in the wet work has the documentation to prove proper functionality, including calibration and preventative maintenance as needed.
Seven key areas: analytical accuracy, precision, reportable range, sensitivity, patient correlation, specificity, and specimen stability
> This is you – our Partner! <
> Define Clinical Performance Parameters:
- Identify clinical performance parameters such as clinical sensitivity, clinical specificity, and predictive values
> Patient Sample Collection:
- Collect a representative set of patient samples, including those from relevant populations and conditions.
> Conduct Clinical Studies:
- Perform clinical studies to assess the LDT’s performance in a real-world clinical setting.
> Data Analysis:
- Analyze clinical data to determine the LDT’s clinical accuracy and reliability.
We deliver a documented validation plan with results. All SOP’s are in CLIA format with test records, deviations and corrective actions completed. Our Medical Director reviews and sign-off.
We ensure that laboratory personnel are adequately trained and competent to perform the LDT and interpret results.
Ongoing internal QC reviews by our CLIA Quality Manager. We prepare for formal CLIA / CAP inspections by maintaining comprehensive records and demonstrating compliance with CLIA regulations.
Service Partnerships
EFFICIENT WORKFLOW SOLUTIONS FOR INTRICATE MOLECULAR ANALYSIS
SeqMatic offers a range of partnerships, from partial Scope of Service validation to full workflow (wet-lab and dry-lab) validation.
CASE STUDIES
SCOPE: Service Validation
Validation of the Sample Extraction workflow
HOW IT WORKS –
- Solid tumor sample collection by our Partner.
- FFPE blocks are shipped to SeqMatic
- CLIA Validation by SeqMatic, including:
- Sectioning
- Staining
- Pathologist Review
Sample Enrichment - DNA Extraction
- QC confirmation of “amplificability”
- Medical Director Review and Approval
- Extracted DNA samples are send back to our Partner, or to another CLIA lab for further processing.
SCOPE: CLIA Subcontractor
Partial Wet-workflow Services
HOW IT WORKS –
- Sample Collection – by our Partner. Samples shipped to SeqMatic.
- CLIA Validation by SeqMatic, including:
- Next Generation Sequencing (including QC)
- Medical Director Review and Approval
- FASTQ data file provided to our Partner
- Bioinformatic analysis (dry-lab) and clinical reporting by our Partner.
SCOPE: Wet-workflow Validation
Full Wet-workflow Services
HOW IT WORKS –
- Sample Collection (by our partner). Samples shipped to SeqMatic.
- CLIA Validation by SeqMatic, including:
- Extraction
- Library Preparation
- Next Generation Sequencing (including QC)
- Medical Director Review and Approval
FASTQ data file provided to our Partner
- Bioinformatic analysis (dry-lab) and clinical reporting by our Partner.
SCOPE: Full LDT Wet-workflow Validation
Full Wet and Dry-Lab Workflow Services (Includes MD Review and Report)
HOW IT WORKS –
- Sample Collection by our Partner.
- CLIA Validation by SeqMatic, including:
- Extraction
- Library Preparation
- Next Generation Sequencing (including QC)
Bioinformatic Analysis (dry-lab) - Medical Director Review and Clinical Report provided to our partner (or Doctor)
SEQMATIC IS A CLIA LICENSED / CAP ACCREDITED LABORATORY
OUR STATEMENTS
Our purpose, Motivation and Drivers
Mission
Vision
Our Vision
To be the preferred outsourcing partner for our customers worldwide by offering multiomics solutions that expedite scientific advancements.
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