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360º Quality

Choosing a Laboratory with specialized experience and ultimate technical competence is a major factor to guarantee the clinical decisions are based on reliable results, minimizing risks that could affect patient security and increasing quality in diagnosis services.

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Quality Policy
  • Igenomix Quality Policy defines our Quality objectives and summarises the essential elements of our commitment for excellence.

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Authorizations, Certifications and Accreditations
See below the set of Authorizations, Certifications and Accreditations that our laboratory has acquired throughout its business development.

  • Sanitary registration
  • CLIA and other USA laboratory licenses
  • ISO
  • Igenomix is registered as a diagnosis centre in the Autonomous Community of Valencia’s register of healthcare centres, services and establishments to genetic activities.

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  • Igenomix has the CLIA (Clinical Laboratory Improvement Amendments) Certification of Compliance (No. 99D2146167), required on the North American market for carrying out genetic tests.

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  • Igenomix is authorized to conduct and maintain a Clinical Laboratory Out of State of Rhode Island in conformity with RIGL C23-16.2. License Number: LCO01501.

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  • Igenomix has obtained a Clinical Laboratory Permit, from the Pennsylvania Department of Health

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  • Igenomix has obtained a Clinical and Public Health Laboratory License, from the California Department of Public Health.

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  • Igenomix has obtained a Non-Expiring Clinical Laboratory License.

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  • Igenomix PGT-M New York Department of Health Interim Waiver Letter.

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  • Igenomix has obtained a New York State Department of Health License.

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  • Igenomix Spain Lab is accredited by ENAC to the ISO 15189 standard for several clinical tests (see list of accredited test).

  • This ISO 15189 accreditation, granted following a review by independent specialists, indicates that Igenomix Spain Lab has the technical expertise, robust operating procedures, and management capability to provide these services to the highest standard.

  • Accredited NGS gene panel list is available under request mailing diagnostic@igenomix.com

Download Accreditation Certificate Download Technical Annex List of accredited tests
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To see the accreditation certificate, associated technical annex and list of accredited tests, click on this link.

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  • Patient Journey
    • Before Pregnancy
    • IVF Process
    • Healthy pregnancy
    • After birth
  • Reproductive Health
    • Specialists
      • ERA
      • ALICE
      • EMMA
      • EndomeTRIO
      • Infertility Panels
      • EMBRACE
      • PGT-A
      • PGT-A Plus
      • PGT-M
      • PGT-SR
      • CGT
      • NACE
      • Zenit
      • POC Portfolio
      • SAT
      • Newborn Screening
  • Diagnostics
  • About us
    • Igenomix Research
    • About Igenomix
    • Igenomix Worldwide
  • Academy
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  • Country/Region
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