Genetic Test Evaluation

understanding how genetic tests impact patient management

The Genetic Test Evaluation program is a compilation of evidence-based assessments of genetic tests that provide clinicians with a clear,
objective view of the science behind genetic tests, the clinical evidence supporting them, and the use of these tests in clinical practice.

View a sampling of our GTE program.

CancerNext-Expanded (Ambry Genetics)

September 20, 2018 Genetic Test Evaluation

This synopsis specifically focuses on the CancerNext-Expanded panel test.

ExoDx Prostate (IntelliScore; Exosome Diagnostics Inc.)

September 18, 2018 Genetic Test Evaluation

This synopsis investigates the urine-based ExoDx Prostate (IntelliScore) test.

DecisionDx-Melanoma

August 31, 2018 Genetic Test Evaluation

The staging of melanoma is important to predict risk of recurrence and guide surveillance and treatment. Current guidelines for staging include evaluating multiple features: tumor thickness, ulceration, regional lymph node status, and metastasis. Staging parameters provide some information of value in disease management, but there is wide variability in rates of metastasis, even for cancers of the same stage, limiting their predictive power. The development of additional tools that may provide more accurate information regarding staging and metastatic risk is, therefore, an area of active interest. One such tool is the DecisionDx-Melanoma test, a multigene expression assay that is designed...

SmartGut (uBiome)

August 30, 2018 Genetic Test Evaluation

This synopsis reviews the peer-reviewed abstract evidence base for SmartGut (uBiome).

FoundationOne CDx (Foundation Medicine Inc.)

August 29, 2018 Genetic Test Evaluation

According to the testing laboratory, the FoundationOne CDx (F1CDx) is a companion diagnostic test used to identify patients who may benefit from treatment with Food and Drug Administration (FDA)-approved targeted therapies. Additionally, the test is intended to provide tumor mutation profiling that includes the screening of biomarkers without companion diagnostic claims. This report evaluates the analytical validity, clinical validity, and clinical utility of the F1CDx test.