Microbial Solutions Facility: Newark, Delaware

Charles River’s Accugenix® laboratory in Newark, Delaware provides cGMP-compliant, ISO 17025 accredited contract testing services for rapid and accurate identification of environmental isolates. We utilize DNA sequencing and MALDI-TOF technologies, including tracking and trending solutions for secure data management.

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Background

  • Founded as AccuLab in 1990 performing microbial identifications by fatty acid analysis.
  • Started performing DNA Sequencing identifications in 1999 under the name Accugenix, Inc. Discontinued fatty acid analysis in 2005.
  • Expanded testing portfolio to include MALDI-TOF mass spectrometer identification services in 2010.
  • Acquired by Charles River Laboratories in 2012 as a wholly owned subsidiary, but retained legal name of Accugenix, Inc.
  • Developed strain typing services in
    2013 and an in-house MALDI-TOF identification solution with Axcess® in 2014.

Laboratories and Facilities

22,000 ft2, approximately two-thirds of which is laboratory space, including dedicated DNA sequencing and MALDI-TOF testing laboratories, and an R&D laboratory.

Staff

Approximately 76 employees, including 20 with Masters & higher degrees.

Service Areas/Study Types

Specialize in microbial identification and strain typing services utilizing Charles River’s proprietary test methods and libraries.

There are currently 9 Accugenix® laboratories worldwide in the US, Brazil, France, Ireland, Germany, Singapore, India, Korea, Australia.

Compliance, Certifications, Accreditations, and Professional Affiliations

Charles River’s Newark, Delaware facility operates in compliance with the requirements of the following regulatory agencies or accredited organizations:

  • Meets US FDA cGMP requirements; registered with the US FDA.
  • ISO 17025 accredited by A2LA for AccuGENX-ID® , AccuPRO-ID®, ProSeq, and MLST. 

Quality and Process Initiatives

  • Origination, development, and validation of all Accugenix® test methods, microbial reference libraries, and software.
  • Development and validation of the Accugenix® Laboratory Information Management Systems (LIMS) and Customer Web Portal used by customers to submit test requests, access results, and perform tracking and trending of their results.
  • Excellent track record of regulatory compliance with ISO assessments, FDA inspections, and Client Audits.
  • The Newark facility has held ISO 17025 accreditation since 2016.

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