Regulated Environment Variant Confirmation

 

PCR + Sanger sequencing allows you to detect or confirm mutations in genomic DNA. This technique is a reliable method for initial analysis or orthogonal confirmation of next generation sequencing, microarrays, or qPCR/dPCR results in clinical samples.

Performed in our state-of-the-art CLIA-certified and CAP-accredited laboratory, and processed by trained personnel on qualified equipment, this service includes optional QA oversight, variant report and/or lab director signature. This service is not CLIA-validated and is not intended for clinical use. The data is research use only.

Microarray Solutions


Service Details

Service Level* Raw Data Files​ QA Oversight Variant Report Lab Director Signature Test Registration Clinical Outcome Report
Regulated Environment

Included | Available as an add-on | Not Available

All service levels are performed by trained personnel in a CLIA-certified lab with qualified equipment.



Applications

Identify or validate variants of interest in complex regions
Confirm work from patient panels or run samples to support registered tests
Orthogonal analysis of next generation sequencing, microarray, and qPCR data
Genotype SNPs of interest in clinical samples for medical device validation


SAMPLE TO ANSWER

1. PROJECT CONSULTATION & PRIMER DESIGN

Amplicon selection and primer design to targeted regions of interest in new or existing assays

2. ASSAY DEVELOPMENT


Optimization on project-specific samples with different validation options

3. PCR & PURIFICATION


PCR amplification of genomic DNA using ideal conditions

4. SEQUENCING & DATA ANALYSIS

Bi-directional DNA sequencing per amplicon with optional variant reporting



Deliverables

All customers receive raw data as .ab1, .seq, and .phd files. QA oversight, variant report and lab director signed quality score report are available as an add-on.