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Accuracy as a core responsibility
Ambry follows a rigorous process with each sample—and since quality and accuracy are basics, we go beyond to achieve both.
“We don’t cut any corners. We don’t sacrifice quality or accuracy for anything.”
— Tom Schoenherr, CEO Ambry Genetics
A human life is attached to every sample and every result. From the time the sample comes in our doors until the report leaves, we follow advanced laboratory procedures and ensure quality control to deliver accurate results you can trust.
Layers of Quality: From Test Design to Results Report
Evidence-Based Test Development
- Every gene is vetted for clinical validity before inclusion in any multigene panel; if the evidence isn’t there, the gene isn’t there
- A weighted scoring system guided by ClinGen standards ensures only genes with demonstrated clinical utility are offered
- The result: appropriate, clinically useful information, and nothing that shouldn’t be there
Clinical Review At Sample Arrival
- A clinical review is performed as soon as a sample arrives, before testing begins
- Ensures the right test is being run for the right clinical indication, reducing the risk of inappropriate test utilization
- Provides clear next steps post-report and reduces the risk of a false negative result due to an incorrect test selection
Advanced Quality Control Steps
- Specialists review samples at multiple steps throughout the process, not just at the end—checking for accuracy, clinical correlation, and quality control
- DNA fingerprinting is applied to every sample, before and after testing. This can detect gender discrepancies and identify potential external sample swaps, ensuring the right result reaches the right patient, every time.
Independent Data Review and Confirmatory Testing
- Variant calls undergo independent data review to improve classification accuracy and ensure clinically concordant results
- When internal conservative thresholds are not met, confirmatory testing of sequencing variants is performed; this reduces the potential for false negative and false positive results
Expert Navigation of Complex Genetic Regions
- Ambry’s experienced team and advanced technologies enable consistent analysis of complex regions, including promoters and pseudogenes
- Complicated result types, such as duplications and splice sites, are interpreted with precision. Many labs struggle with these types of results and Ambry’s depth of expertise makes the difference to provide clear and actionable results.
Practical and Individualized Result Reports
The Ambry report goes beyond a result code for every patient. It is a clinical document designed to be immediately useful to the ordering provider.
- Customized interpretation of results based on the patient’s unique clinical presentation, not a generic boilerplate
- Robust detail about the classification process, offering greater understanding of what the result means and why