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Partnerships for Clinical Applications

Comprehensive Solutions For Assay Validations

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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
  • clinical trials
  • targeted therapy programs
  • novel treatment studies

In the United States and Internationally – whether multi-site collaborations and/or unique requirements, 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).

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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 aligns with your technical, regulatory, and operational process. A few details can make all the difference in your results.

  • Choose services that support LDT implementation in compliance with CMS, FDA, and CDC standards.
  • Choose flexibility, assess your options for a wet-lab with or without dry-lab services, or 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. 

  1. Accreditation & Compliance
  2. Expertise & Technical Depth
  3. Technology, Infrastructure & Capabilities
  4. Global Logistics & Sample Management
  5. Turnaround Time & Operational Agility
  6. Sample Stewardship & Problem‑Solving
  7. Communication & Collaboration
  8. Data Security & Ownership
  9. Flexible Engagement Models
  10. BIOSECURE Act Compliance

Access This Exclusive Content

Unlock access to our premium content by filling out the form below. Get instant access to guidelines and key considerations when selecting a CLIA laboratory for assay validation.

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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 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!

Review and approval of the validation plan by our Medical Director

Review and approval of the validation plan by our Medical Director

> 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.

> 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 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!

Service Partnerships

EFFICIENT WORKFLOW SOLUTIONS FOR MOLECULAR ANALYSIS

Select from a range of partnerships, from partial scope of service validation to full workflow (wet-lab and dry-lab) validation.

SeqMatic partnerships deliver detailed, context-rich insights tailored to your chosen service area and analytical objectives. Each partnership is designed to be both descriptive and exploratory, offering several core features:

  • In-depth analysis that integrates both qualitative and quantitative data
  • Contextual understanding, capturing all relevant variables that influence experimental setup and results
  • Flexibility, allowing for customized options and solutions as needed
  • Purpose-driven alignment, functioning as an extension of your laboratory to ensure that workflows and analyses are executed according to defined objectives and within critical timelines

EXAMPLES OF SERVICE OPTIONS

SCOPE: Scope of Service Validation

Validation of the Sample Extraction workflow with enrichment

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
    • FASTQ data file provided to our Partner
  • Extracted DNA samples are sent back to our Partner, or to another CLIA lab for further processing.

SCOPE: CLIA Subcontractor

Partial Wet-workflow Services (sequencing only)

HOW IT WORKS –

  • Sample Collection, Extraction & Library Prep – by our Partner. Libraries 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)

Handling of
Precious Samples

We treat them
as our own.

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Every sample is precious and often unreplaceable.

Our scientific teams care about the samples they process, ensuring quality, efficiency, expert troubleshooting and workflow optimization.

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Seamless &
Sequencing Analysis

An Extension of
Your Laboratory

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Expert Science by Expert Hands

Conscientious attention to detail and a science-first approach alignment to reach the goals of your study.

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Fast Turnaround
Time Deliverables

Custom workflows to
target specific goals and reads.

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Tailor-made Services with Fast TAT

Quick processing that supports batch sizes from a few samples to thousands per week.

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Advanced Technology &
Global Logistics

We treat them
Flexible Engagement Models

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Optimal Solutions for Your Analysis Goals

The application of best science, higher quality data, more read depth per lane, and fast delivery makes SeqMatic an exceptional partner and value per research dollar spent.

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EFFICIENT WORKFLOW SOLUTIONS FOR MOLECULAR ANALYSIS

Pre-Clinical & Clinical Laboratory Services
CLIA / CAP Laboratory Services

SeqMatic Referral Program

Earn referral perks for you and your referred colleagues.