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Mon - Fri 9AM - 7PM PSTComprehensive Solutions For Assay Validations
SeqMatic provides CLIA certified, CAP accredited laboratory services for diagnostic developers, biotechnology companies, pharmaceutical sponsors, and clinical laboratories developing next generation sequencing (NGS) assays. We support Laboratory Developed Test (LDT) validation, companion diagnostic (CDx) development, clinical trial sequencing, and regulated genomic testing from assay transfer through clinical reporting. All work is performed in our Fremont, California laboratory, with no subcontracting to third party or overseas facilities.
Our clinical laboratory can provide clinically validated DNA and RNA sequencing services used to support patient care. Applications include hereditary disease testing, cancer genomic profiling, infectious disease detection, pharmacogenomic testing, and sequencing based companion diagnostics, along with validated bioinformatics analysis and clinical reports intended for use by healthcare providers.
A SeqMatic partnership means that our scientific team becomes an extension of your laboratory and project team, and you work directly with the scientists handling your samples throughout the workflow.
SeqMatic’s clinical work is led by a team with direct CLIA laboratory and Medical Director experience.
In brief: SeqMatic runs the regulated wet lab, and dry lab work as applicable, for your clinical NGS program, from a single sequencing step through full assay validation and clinical reporting.
A SeqMatic laboratory services partnership is a structured engagement in which SeqMatic provides wet lab and dry lab sequencing services for a defined clinical or translational program. Partnerships range from a single workflow component (sequencing runs only) to full onboarding and validation of an entire workflow, including sample accessioning, biobanking, extraction, library preparation, sequencing, bioinformatics, Medical Director review, and clinical reporting. The project scope, deliverables, and data ownership terms are defined upfront.
Partnerships are appropriate for:
SeqMatic’s clinical laboratory supports LDT validation, companion diagnostics, clinical trial sequencing, drug and assay development, and targeted therapy and novel treatment studies.
A Laboratory Developed Test (LDT) is an in vitro diagnostic test that is designed, manufactured, validated, and used within a single CLIA certified laboratory. SeqMatic validates LDTs that use NGS readouts, covering assay onboarding, feasibility, analytical validation, documentation, training, and inspection readiness under CLIA Medical Director oversight.
SeqMatic supports the analytical validation, documentation, and data packages used in companion diagnostic (CDx) development programs, working with sponsor regulatory teams during FDA submission planning.
SeqMatic provides NGS workflow services for clinical trials. Multi collection center coordination, sample batching and tracking, and chain of custody are core to clinical trial partnerships, supported by import permits from the US Centers for Disease Control (CDC) for biospecimens imported from global collection sites.
For sponsors developing therapeutics or new assays that require NGS readouts, SeqMatic supports feasibility, workflow optimization, and scale up. The regulated laboratory environment lets pre-clinical development data transition into clinical phase work without changing laboratory services partners.
Targeted therapy programs and novel treatment studies, including cell and gene therapy, often require sequencing for patient identification, response monitoring, off target analysis, or pharmacodynamic readouts.
SeqMatic validates NGS based LDTs through a defined 10 step workflow, from team setup and feasibility through analytical validation, documentation, and inspection readiness.
SeqMatic follows a structured 10 step validation workflow for LDT assays, aligned to CLIA Analytical and Clinical Validation requirements.
In cooperation with our customer, we assign a multidisciplinary team responsible for planning and executing the validation study.
We onboard your NGS assay, train the SeqMatic CLIA team, and perform workflow optimization, with the goal of demonstrating equivalent or better results in our laboratory than in yours.
We add your assay to the SeqMatic LIMS for sample accessioning, tracking, and reporting. APIs can be developed to interface with customer LIMS and logistics systems.
Our Medical Director reviews and approves the validation plan.
All key equipment used in the wet work carries documentation proving proper functionality, including calibration and preventive maintenance as needed.
Analytical validation demonstrates that the test accurately and reliably measures the genetic variant or biomarker it claims to measure. Analytical validation evaluates:
Clinical validation is typically sponsor-led and demonstrates that test results are clinically associated with the intended disease or therapeutic decision. SeqMatic supports the laboratory components of these studies and provides the analytical data required for validation. It answers whether the detected variant or biomarker predicts, diagnoses, or informs treatment for a disease in the intended patient population, typically using published evidence and clinical studies. This includes defining clinical performance parameters (clinical sensitivity, clinical specificity, predictive values), collecting a representative set of patient samples, and conducting clinical studies in a real-world clinical setting.
We deliver a documented validation plan with results. All SOPs are in CLIA format with test records, deviations, and corrective actions completed, then reviewed and signed off by our Medical Director.
We ensure laboratory personnel are adequately trained and competent to perform the LDT and interpret results.
Our CLIA Quality Manager conducts ongoing internal QC reviews and prepares 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!
Engagements range from sequencing only subcontracting to full wet and dry lab validation with a clinical report. Here are four examples of service models:
Our partner collects solid tumor samples and ships FFPE blocks to the SeqMatic clinical laboratory. SeqMatic performs CLIA validation including:
High purity extracted tumor DNA is returned to the partner or to another CLIA lab for further processing.
Partial wet workflow. Our partner performs sample collection, extraction, and library preparation, then ships the libraries to SeqMatic. SeqMatic performs:
Bioinformatic analysis (dry lab) and clinical reporting are handled by our partner.
Our partner collects and ships samples. SeqMatic performs:
Bioinformatic analysis (dry lab) and clinical reporting are handled by our partner.
The partner collects samples. SeqMatic performs:
HOW IT WORKS –
HOW IT WORKS –
The partner collects samples. SeqMatic performs:
SeqMatic is CLIA certified, CAP accredited, and California state licensed, with GLP compliance.
Founded in 2012 by former Illumina R&D scientists, SeqMatic brings deep expertise and troubleshooting skills across the full NGS workflow: extraction, library preparation, sequencing, and bioinformatics. Troubleshooting and optimization are a core strength, supported by customer references and publications.
Qualified benchtop and production scale Illumina sequencers (NovaSeq X Plus, NovaSeq 6000, NextSeq, MiSeq), QC instrumentation, process automation, a full service histopathology lab, a HIPAA and CLIA compliant LIMS for end to end sample tracking, biobanking capacity, and a full time in-house bioinformatics team.
SeqMatic maintains applicable CDC import permits for eligible biospecimens when required. We receive clinical samples from global collection sites, accession and track samples using a CLIA and HIPAA compliant LIMS, batch samples for efficient processing, and deliver data securely to a client portal.
SeqMatic supports batch sizes from a few samples using manual workflows to hundreds per batch using automated instruments, targeting fast turnaround without compromising quality.
Every sample represents a patient and is often irreplaceable. A problematic sample (low input, degraded, diluted) is not simply failed at QC. Our scientific team discusses each challenging sample with our customer and works to find the best path to a usable result.
You communicate directly with the scientists handling your samples, receive status updates at key workflow stages, resolve challenges collaboratively, and can view project status through a secure LIMS client portal.
SeqMatic maintains SOC 2 Type 2 and HIPAA compliance, with third party penetration testing, continuous vulnerability scanning, encryption at rest and in transit, role based access control, audit logging, and a formal incident response program. All data, results, and documentation generated under contract remain the exclusive property of the client.
Choose from partial workflow services (sequencing only subcontracting), wet lab only services with FASTQ delivery, or full workflow (wet and dry lab) onboarding and validation including Medical Director review and clinical reporting.
The BIOSECURE Act, enacted in December 2025 as part of the Fiscal Year 2026 National Defense Authorization Act, restricts US federal agencies, contractors, and grant recipients from using biotechnology equipment or services from designated biotechnology companies of concern, defined as entities owned or controlled by foreign adversary governments. The Act addresses concerns that sensitive US genomic, health, and other biological data could be accessed or exploited through biotechnology companies viewed as posing national security risks.
SeqMatic is a US owned and operated, CLIA certified laboratory in Fremont, California. All work is performed in house in the United States, with no subcontracting to third party or overseas facilities. As such, SeqMatic’s US based operations align with the supply chain objectives the Act addresses.
For a complete list of critical considerations when selecting a service partner for your NGS assay, download our guide:
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A laboratory services partnership provides the clinical laboratory expertise, regulatory infrastructure, sequencing workflows, bioinformatics, and reporting required to support regulated NGS programs from assay validation through patient testing.
A laboratory services partnership at SeqMatic is a structured engagement in which SeqMatic provides NGS workflow services, full or partial, for a sponsor’s clinical, translational, or regulated program. SeqMatic is a CLIA certified, CAP accredited omics services laboratory in Fremont, California. Clinical partnerships include LDT validation, companion diagnostic (CDx) development, clinical trial sequencing, and assay development and optimization.
Scope ranges from a single workflow component (sequencing only) to full onboarding and validation, including accessioning, biobanking, extraction, library preparation, sequencing, bioinformatics, Medical Director review, and clinical reporting.
CLIA certification is the federal requirement, administered by the Centers for Medicare and Medicaid Services (CMS), that a laboratory must meet to perform clinical testing on human samples in the United States. CAP accreditation is a rigorous peer inspection program from the College of American Pathologists that CMS recognizes as meeting or exceeding CLIA requirements. SeqMatic holds both, so testing is performed under federal quality standards and independently inspected against them.
A Laboratory Developed Test is developed when no suitable FDA cleared or approved test exists for a given intended use, or when a laboratory needs a test tailored to a specific sample type, biomarker, or patient population. The LDT is designed, validated, and used within a single CLIA certified laboratory under Medical Director oversight.
Yes. Assay transfer is the first stage of the validation workflow. SeqMatic onboards your NGS assay, trains the clinical team, performs workflow optimization, and demonstrates equivalent or better performance in our laboratory before the assay enters validation and routine use.
A Laboratory Developed Test is designed, developed, and executed within a single CLIA certified laboratory. Yes, SeqMatic validates LDTs that use NGS readouts. The workflow covers onboarding, feasibility, CLIA analytical validation across nine parameters (accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference interval where appropriate, limit of detection, reproducibility, and robustness), Medical Director approval, clinical reporting, documentation, training and competency, and CLIA/CAP inspection readiness.
SeqMatic performs clinical NGS on its qualified Illumina portfolio: NovaSeq X Plus, NovaSeq 6000, NextSeq, and MiSeq. Platform and read configuration are matched to the assay during onboarding.
Yes. SeqMatic offers wet lab only engagements that deliver FASTQ files, and full wet and dry lab engagements that add primary, secondary, and tertiary bioinformatics analysis, Medical Director review, and a clinical report. The dry lab work is handled by a full time in-house bioinformatics team.
Yes. The BIOSECURE Act addresses concerns that sensitive US genomic, health, and other biological data could be accessed or exploited through biotechnology companies viewed as posing national security risks. It restricts US federal agencies, contractors, and grant recipients from using biotechnology equipment or services from designated biotechnology companies of concern. SeqMatic is a US owned and operated, CLIA certified laboratory in Fremont, California, performing all work in house with no overseas subcontracting. SeqMatic’s US based operations align with the supply chain objectives the Act addresses.
Yes. SeqMatic maintains applicable CDC import permits for eligible biospecimens when required, and routinely receives clinical samples from global collection sites. All samples are accessioned and tracked in the SeqMatic LIMS, batched for efficient processing, and data is delivered securely through a client portal.
SeqMatic supports the laboratory components of companion diagnostic programs, including analytical validation, documentation, and the data packages used during FDA submission planning. The sponsor leads the regulatory submission; SeqMatic provides the clinical laboratory work and validation data that support it.
SeqMatic accepts extracted nucleic acids, whole blood, plasma, serum, fresh and cryopreserved tissue, FFPE blocks and sections, and pre-made sequencing libraries. The laboratory has specific expertise with low input, degraded, and FFPE material. Accepted sample types are confirmed during the project consultation step.
Turnaround depends on the engagement scope and the validation requirements of the assay, and is defined per project during consultation. SeqMatic supports batch sizes from a few samples using manual workflows to hundreds using automated instruments, and targets fast turnaround without compromising quality.
All data, results, algorithms, and documentation generated under contract are the exclusive property of the client and are not used or disclosed without prior written consent. Data is protected through SOC 2 Type 2 and HIPAA aligned controls, encryption at rest and in transit, role based access, and audit logging, and is delivered through a secure client portal.
