Testing laboratories are under constant pressure to stay compliant with standards while expanding the number of molecular tests offered. Validating a workflow is one of the most critical steps prior to launching a new test successfully. Yet, many labs inadequately plan and execute their analytical validation (AV) process. Inefficient AV can potentially turn a 10-week validation
into a 40-week or more process, resulting in substantial delays to the lab’s ability to process valuable samples and significantly impacting the lab's business.
Our analytical validation consulting services provide technical project management of your lab’s AV, potentially reducing your overall time to launch by 75%.
With over 350 successful AV engagements to date, our experienced AV project managers and global compliance service specialists help ensure successful AV outcomes.
Save Time—Get personalized consultation to help accelerate your launch up to 75% faster than the average AV
Cut Costs—Help reduce costs and provide transparency of your end-to-end investment with up to 48% less financial impact than the average AV
Maintain Compliance—Receive proper documentation templates that facilitate your lab compliance
See an overview of the steps of the AV process and how our AV consulting services can help reduce your timeline for launching new molecular tests.
The AV consulting services can reduce your overall investment by up to 48% because of the time savings the service provides. Labs that perform AV themselves pay more in materials and labor, potentially incurring months of loss in revenue opportunity due to delays in sample processing.
|As part of the engagement, our team provides key services throughout the process including:|
|Project management by an AV specialist|
|Dedicated on-site field applications specialist|
|Workflow training and optimization|
|Optional: Confirmatory orthogonal testing support|
What you receive:
|Validation plan template|
|Samples and controls|
|Data analysis consultation|
|Final report template|
|Optional: Orthogonal testing consultation|
Consider starting with a pre-validation evaluation. Our assay validation readiness (AVR) service helps save you time and costs by determining whether your workflow is ready to move on to a complete analytical validation.
Guided by our global compliance services specialist (GCSS), the AVR service enables you to evaluate your workflow on a controlled scale, and helps you improve your chances for success before investing in a full scale assay workflow. The AVR service includes:
Qualified solutions supported by our AV consulting services
|Real-time PCR panels for infectious disease||Panel||AV consulting services Cat. No.|
|Pharmacogenomics, OpenArray format||Panel||AVQS12K|
|Pharmacogenomics, 384-well format||Panel||A27145|
|Cystic Fibrosis, OpenArray format||Panel||A28279|
|Vaginal Microbiota, OpenArray format||Panel||A28966|
|Urinary Tract Microbiota, OpenArray format||Panel||A34087|
|Respiratory, OpenArray format||Panel||A40372|
|Antibiotic Resistance add-on, OpenArray format||Panel||A42820|
|Toe Nail Fungus, OpenArray format||Inquire||A40371|
|Wound, OpenArray format||Inquire||A34091|
|Custom qPCR Panel||Inquire||A34091|
|Additional AV consulting services for real-time PCR panels|
|AV Consulting Services, custom panel||A34091|
|Workflow training, genotyping panel||A26745|
|Workflow training, microbial panel||A30162|
|Oncomine assays for oncology research||Assay||AV consulting services Cat. No.|
|Ion Torrent Oncomine Myeloid Research Assay||Assay||A39199|
|Ion Torrent Oncomine Comprehensive Assay||Assay||A34088|
|Ion Torrent Oncomine Tumor Mutation Load Assay||Assay||A39199|
|Ion Torrent Oncomine Immune Response Assay||Assay||A39199|
|Ion Torrent Oncomine Focus Assay (OFA)||Assay||A34088|
|Ion Torrent Oncomine Childhood Cancer Research Assay||Assay||A39199|
|Ion Torrent Oncomine Inherited Cancer Assay||Inquire||A39199|
|Custom Analytical Validation Consulting Services, custom assay||A42904|
|Additional AV consulting services for Oncomine assays|
|Oncology consultation only, custom assay||A39199|
|Oncology controls only||A39558|
|Additional NGS instrument||A41777|
|Confirmatory testing, NGS platform||A39200|
|Confirmatory testing, Sanger sequencing platform||A39201|
|Confirmatory testing, qPCR platform||A39202|
|Confirmatory testing, regent kit (custom)||A39203|
|Assay validation readiness service for NGS instruments||A43330|
Analytical validation consulting services (brochure)Analytical validation consulting services for NGS assays (flyer)Assay validation readiness service–a pathway to process validation (flyer)Analytical validation consulting service aids launch of new laboratory-developed tests (case study)Analytical Validation of the Oncomine Pan-Cancer Cell-Free Assay (white paper)CAP webinar on Analytical Validation Requirements for Next Generation Sequencing (webinar)
For Research Use Only. Not for use in diagnostic procedures.