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Consultation Services

Arbelos Genomics enables smooth operations of complex molecular testing in new and existing diagnostic laboratories.

Our expertise is in molecular genetics and molecular pathology, with integrative capabilities in designing custom NGS gene panels, bioinformatics pipeline development, tertiary analysis, and reporting. We help our clients optimize their operational efficiencies, while developing strategies to remain competitive in today’s challenging regulatory environment.

NGS Testing Development Consultation

  • End-to-end test implementation project planning

  • Validation sample procurement assistance


Bioinformatics and IT Customized Solutions

  • Bioinformatics pipeline and IT infrastructure design/maintenance

  • Validation of bioinformatics and IT system in accordance with CLIA/CAP regulations

Regulatory and Compliance Consultation

  • Ensure quality control and quality assurance for entire workflow

  • Support quality and compliance standards in accordance with CLIA/CAP regulations


Staffing and Training Solutions

  • Clinical laboratory scientist for molecular testing

  • Variant classification and report sign-out support


FDA In Vitro Diagnostics Consultation

  • Arbelos Genomics understands the urgency of developing emergency use diagnostic tests during the COVID-19 pandemic. Per the Federal Food, Drug, and Cosmetic Act (FD&C Act), the US Food and Drug Administration allows for the emergency use of some medical products under certain circumstances. An Emergency Use Authorization (EUA) provides FDA with the authority to support emergency preparedness and response, including supporting the development and availability of unapproved or new medical products (drugs, biological products and medical devices) for use in emergency situations.

  • We help medical device manufacturers increase the success rate of their FDA EUA submission, through the following steps:

  • Project management

  • Document review - gap analysis, design control, risk assessment

  • Pre-EUA submission - discuss product testing and clinical expectations

  • Data generation - Analytical performance studies

  • Patient enrollment/clinical sample procurement consultation

  • Compile EUA submission to the FDA, engagement interface with FDA

  • Post-Submission Support

Successful Approval Example: KimForest SARS-CoV-2 Detection Kit

  • Arbelos Genomics assisted KimForest, a Taiwanese manufacturer in submitting their EUA for their RT-qPCR kit in September, 2020. See letter of authorization below: 


Inquire US for pricing and validation/verification service

Third party FDA LoD Blind Test for RT-PCR

Using standard panel from FDA to establish Limit of Detection for approved COVID-19 test kits

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