The clinical molecular laboratory, which carries both CLIA and CAP accreditations, offers molecular genetics services such as DNA extraction, identification and validation of public and proprietary genetic variants, real-time PCR assay design and validation, Sangers sequencing with ABI3730xl high throughput instruments and customized clinical reporting.

Main Service Offering

• Genomic DNA extraction
• Assay design, development, and validation for:
  - Single nucleotide polymorphisms (SNP)
  - Small insertions and deletions (indel)
  - Fragment analysis
  - Microsatellites
• High-throughput genotyping
• Mutation confirmation for Next Generation Sequencing

List of Clinical Assays Available

Accreditation

Eurofins clinical staff has more then 30 years of experience with molecular testing. Contact us today for more information.

	Sequencing projects are available for clinical applications, accredited under the Clinical Laboratory Improvement Amendments, from our local, Louisville, KY laboratory. Typical projects includeo DNA extraction, identification and validation of public and proprietary genetic variants, real-time PCR assay design and validation, Sangers sequencing with ABI3730xl high throughput instruments and customized clinical reporting. More information is available on the CLIA tab. Request Info
	CAP allows for testing on humans to animals, and is one of the highest accreditations a laboratory can receive. Projects are run from our local, Louisville, KY laboratory. More information is available on the CLIA & CAP tab. Request Info
CAP Accredidation	CLIA Certification

Sequencing under Good Laboratory Practices (GLP)

Please note that these services will be performed at our laboratory in Ebersberg, Germany.

Sequence confirmation by primer walking or by PCR amplification and sequencing.

To analyse DNA for non-clinical laboratory studies, we offer GLP certified sequencing services:

• Quality control of incoming DNA
• Design and synthesis of required primers
• Double strand sequence confirmation (2fold or 4fold coverage) by primer walking or by PCR amplification and sequencing
• Guaranteed accuracy of final data: 2fold coverage: > 99.999% and 4fold coverage: > 99.99999%

Nucleic acid extraction, reverse transcriptase or DNA cloning are available on demand.

Study deliverables:

• Customised study plan and study report according to customers' requirements
• Detail description of utilised materials and procedures
• Alignment of sequences based on Q30 quality clipped reads (accuracy 99.9%) and coverage overview
• Quality check and report for the generated consensus sequence
• Raw sequence data with quality assignment
• Verification of a reference sequence and variation report if applicable
• Comprehensive information about detected mutations (mutation report if applicable)
• Signed quality assurance (QA) statement
• Storage of test items for one year
• Archiving study data for 15 years

To ensure the quality of our GLP certified sequencing service, we are routinely assessed by first and second external auditors. Additionally we perform regularly facility and process audits.

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Sequencing services: GLP certified, ISO 9001 and ISO 17025 accredited

Our QM and QA system for DNA sequencing is based on regulatory requirements, (OECD-GLP, acknowledged standards (ISO 9001 / ISO 17025) and best practices (CLSI).

Our long-year expertise is just one of the reasons why our GLP certified sequencing service is excellent for non-clinical laboratory studies. Our products and services are also certified according to ISO 9001, and accredited according to ISO 1702.

Our GLP certified sequencing service is based on OECD GLP and includes the following features:

• Fully validated procedures and equipment
• Regularly equipment calibrations
• Continuous personnel training on SOP's and procedures
• Restricted laboratory access
• Established SOP's and program procedures
• Complete study documentation
• Complete sample tracking for uncompromised sample and data integrity (chain of custody)
• All studies are inspected by our independent quality assurance department
• Comprehensive reporting including study plan and final study report

Eurofins Genomics is frequently assessed by auditors from DEKRA (ISO 9001 / ISO 13485), DAkkS (ISO 17025) and LGL (GLP), and different customers.

Sequencing services: GLP certified, ISO 9001 and ISO 17025 accredited

Sequencing is performed according to standard methods and in compliance with

• CLSI Guideline MM9-A; Vol. 24 Nr. 40, 2005; Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine, Approved Guideline, 2005

Conduct of sequencing studies is performed according to

• OECD Guideline ENV/MC/CHEM(98)17 (rev.1999): The Principles of Good Laboratory Praxis (Monograph No. 01) and OECD Guideline ENV/JM/MONO(1999)23 (rev. 2002): Short Term Study and GLP (Monograph No. 07)

Quality assurance (QA) activities related to sequencing studies (review of the study plan, inspection of study, study report and raw data) are conducted according to

• OECD Guideline ENV/JM/MONO (1999) 20 (03-October-2002): Quality Assurance and GLP

Accreditation

	Sequencing projects are available under Good Laboratory Practices (GLP) from our facility in Ebersberg, Germany. Projects include sequence confirmation by primer walking or by PCR amplification and sequencing. More information is available on the GLP tab. Request Info

Eurofins Genomics has earned high accredication for sequencing within clinical and regulated industries

	Sequencing projects are available for clinical applications, accredited under the Clinical Laboratory Improvement Amendments, from our local, Louisville, KY laboratory.  Typical projects includeo DNA extraction, identification and validation of public and proprietary genetic variants, real-time PCR assay design and validation, Sangers sequencing with ABI3730xl high throughput instruments and customized clinical reporting. More information is available on the CLIA tab. Request Info
	CAP allows for testing on humans to animals, and is one of the highest accreditations a laboratory can receive.  Projects are run from our local, Louisville, KY laboratory. More information is available on the CLIA & CAP tab. Request Info
	Sequencing projects are available under Good Laboratory Practices (GLP) from our facility in Ebersberg, Germany.  Projects include sequence confirmation by primer walking or by PCR amplification and sequencing.  More information is available on the GLP tab. Request Info