FulgentExome | Fulgent Genetics

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NEW PRODUCT

FulgentExome is CE-Marked for Quality and Compliance

FulgentExome provides a robust, CE-marked solution for clinical exome analysis, enabling the identification of germline variants associated with genetic disorders. Powered by advanced NGS technology and a proprietary CE-marked bioinformatics pipeline (FPLM), FulgentExome ensures high accuracy, reliability, and expert-driven interpretation to support clinical diagnostics.

Features

Comprehensive Coverage
Targets 6,717 clinically significant genes, providing >99% coverage at 20x depth for coding regions and splice sites.
CE-IVD Compliance
Certified under IVDR 2017/746, ensuring quality and compliance for clinical use in the EU.
Phenotype-Driven
Genetic results are interpreted in the context of the patient's disease for maximum clinical relevance and actionability.

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In-Depth Analysis

FulgentExome provides in-depth insights into the genetic basis of disease by detecting single nucleotide variants (SNVs), small insertions and deletions (INDELs), and copy number variants (CNVs) across the exome.

Our test leverages a phenotype-driven approach, tailoring analysis to the patient's clinical presentation and family history. Findings are interpreted using established professional guidelines — providing clinicians with clear, patient-centric results to guide diagnosis and care.

Important

Results must be interpreted by qualified healthcare professionals in conjunction with clinical findings, family history, and other relevant diagnostic information.

TARGET USERS

Clinical laboratory professionals
Medical geneticists
Healthcare providers
Genetic counselors

CLINICAL APPLICATIONS

Hereditary disease diagnosis
Genetic variant identification
Clinical decision support
Cascade testing programs

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Why Is CE Marking Important?

Compliance with International Regulations

CE marking indicates that a device meets applicable safety, performance, and quality requirements that allow it to be marketed and used in the European Economic Area. The EU and other international entities, including organizations in Asia-Pacific and Latin America, recognize CE for its high standards, often facilitating faster and smoother workflows on a global scale.

Clinically Validated Assays

All CE marked assays are supported by technical documentation and performance data required under EU law. This provides clinicians, researchers, and partners with assurance that the product has been evaluated for its intended purpose. This can be a deciding factor in vendor selection for clinical trials and diagnostic partnerships.

Direct Integration into Clinical Programs

CE marked products are designed for use in clinical workflows within the EU, which can support integration into healthcare systems and clinical programs.

TEST DETAILS

FulgentExome is a qualitative, semi-automated, next-generation sequencing (NGS) based system designed for clinical exome analysis to identify germline variants for the purpose of aiding the diagnosis of suspected genetic condition(s) within a patient's clinical and family history.

Sensitivity: ≥99% for SNVs and INDELs
Turnaround Time: 3-5 weeks

SPECIMEN TYPES ACCEPTED

Peripheral Blood
Buccal or Saliva Swabs
Cultured Cells
Extracted DNA

QUALITY STANDARDS

Manufactured in an ISO 13485-compliant facility and adheres to ISO 15189 for laboratory testing services.

FULGENTEXOME REPORTS

The FulgentExome report is thoughtfully designed with a clean, organized layout, making complex genetic information easier to read, interpret, and apply in clinical practice.

Regulatory Status: CE-marked in vitro diagnostic device under IVDR

How to Order

Contact Our Team

Reach out to learn more about FulgentExome's capabilities at info@fulgentgenetics.com

Onboard Your Facility

Set up your account and let us guide you through your first order.

Order & Submit Samples

Send patient specimens to our laboratory for processing. Reports are sent to the ordering provider within 3-5 weeks.

REGULATORY DISCLAIMERS

CE-Marking: FulgentExome is CE-IVD certified under IVDR (EU) 2017/746, ensuring compliance with European regulatory requirements.
Intended Use: For clinical diagnostics performed by qualified healthcare professionals.
Quality Management: Operates under ISO 13485-compliant manufacturing and ISO 15189 laboratory standards.

REGULATORY INFORMATION (Based on EU IVDR 2017/746)

This test will be conducted using CE-marked devices that comply with Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The devices involved—FulgentExome and FulgentPLM—have defined intended uses and comprehensive documentation, including warnings and precautions, operating instructions, and information regarding biological and hazardous substance content, as outlined in their respective Instructions for Use (IFUs). These IFUs are available internally to trained Fulgent personnel, who are the intended users of the FulgentExome and FulgentPLM assays. Clinicians - and their patients - who request these tests may access the IFUs and SSPs of these CE-marked devices by contacting the following email address: info@fulgentgenetics.com.