The Agency for Healthcare Research and Quality (AHRQ; Rockville, Md.) recently released an updated technology assessment that identifies 178 commercially available genetic tests for common cancers. The report, “Update on Emerging Genetic Tests Currently Available for Clinical Use in Common Cancers,” was conducted at the request of the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services and is intended to aid both payers and providers in making informed decisions about emerging molecular tests. The assessment, conducted by the Tufts Medical Center Evidence-Based Practice Center, covers a range of genetic tests (genetic variations, panels of genetic markers, measurements of gene expression and transcription products, and biochemical biomarkers) that are already available in clinical practice, particularly for the management of Medicare-aged adults. The tests are used in patients with 10 common solid tumors and hematologic cancers (including breast, lung, colorectal, pancreas, leukemia, and lymphoma) for diagnosing, treating, predicting, prognosticating, monitoring, and detecting cancer recurrence. The report covers tests that are U.S. Food and Drug Administration-cleared (or pending clearance), conducted in CLIA-certified labs and require a physician order, or are offered by Internet sites that specifically require a physician order. The authors caution that the included tests are based […]
The Agency for Healthcare Research and Quality (AHRQ; Rockville, Md.) recently released an updated technology assessment that identifies 178 commercially available genetic tests for common cancers.
The report, “Update on Emerging Genetic Tests Currently Available for Clinical Use in Common Cancers,” was conducted at the request of the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services and is intended to aid both payers and providers in making informed decisions about emerging molecular tests.
The assessment, conducted by the Tufts Medical Center Evidence-Based Practice Center, covers a range of genetic tests (genetic variations, panels of genetic markers, measurements of gene expression and transcription products, and biochemical biomarkers) that are already available in clinical practice, particularly for the management of Medicare-aged adults. The tests are used in patients with 10 common solid tumors and hematologic cancers (including breast, lung, colorectal, pancreas, leukemia, and lymphoma) for diagnosing, treating, predicting, prognosticating, monitoring, and detecting cancer recurrence.
The report covers tests that are U.S. Food and Drug Administration-cleared (or pending clearance), conducted in CLIA-certified labs and require a physician order, or are offered by Internet sites that specifically require a physician order. The authors caution that the included tests are based on a review of “grey sources,” including Internet news searches, commercial and manufacturers’ Web sites, and the National Institutes of Health’s Genetic Testing Registry, and should not be construed as definitive clinical evidence or as recommendations endorsing their routine clinical use.
In total, the horizon scan reports have identified 178 different genetic tests including 66 new genetic tests since 2011 with the largest number of these tests being utilized for breast cancer. The most frequent indication for use of all of the identified tests was for therapeutic management.
A total of 21 of the 104 tests “in development” in the 2006 report matured to clinical use, with 76 tests currently being identified as tests in development or in research. Several tests listed in a previous report were removed: Three tests (PyloriProbe, PreGen Plus, and OvaSure) have been withdrawn from the market, two tests are used in the context of aspiration of cervical or breast specimens, and one test evaluates genetic material of infectious agent. AHRQ will continue with horizon scans as it is anticipated that the number of clinically available genetic tests will continue to increase in the coming years.
