Hayes, Inc. launches Genetic Test Evaluation (GTE), a subscription-based, online service that provides insurers, hospitals and policy makers objective insight into the clinical utility of genetic tests. Hayes GTE is a powerful tool designed to sort through the entanglement of information and clinical trial data surrounding the more than 1200 genetic tests that are currently available to doctors and patients.
"As these tests come to the forefront of diagnosis and treatment of disease, there are many questions regarding their accuracy, validity, and clinical utility," says Winifred S. Hayes, PhD, president and CEO of the company. "Hayes GTE provides a clear, objective view of the science behind these tests, the hard clinical evidence supporting them, and the use of the tests in clinical practice."
The clinical, ethical, and financial implications of these tests are broad and pressing. Hayes GTE is the first evidence-based service to address these issues through application of the Hayes Rating, a proprietary system that is a standard in the industry. The evidence behind each test is critically appraised to evaluate the analytical validity, clinical validity, and clinical utility. Ratings range from "A, Established Benefit," meaning that there is good evidence that the test has validity and utility, to "D, No Proven Benefit," which means that the test lacks validity or utility, or that there is insufficient evidence to evaluate the test.
"Millions of dollars are being spent on genetic tests by hospitals and insurers, and by consumers," says Dr. Hayes. "But our initial analysis indicates that the evidence is insufficient to substantiate the clinical validity and utility of many of these tests, despite their increasing use." In fact, the Hayes international team of medical analysts found inadequate evidence for some of the most widely used genetic tests for breast cancer, including Mammostrat, MammaPrint, Oncotype DX, and Rotterdam Signature, which all received Hayes Ratings of C or lower.
"Just as disconcerting," says Dr. Hayes, "is that many of these tests suggest a correlation to disease, which could unnecessarily cause concern among patients who may never develop the disease. In other cases, there may be no way to prevent or treat the disease, and it's unclear how the test result can be used to improve patient management. It's essential that these tests be used only when there is evidence that there will be some benefit to the patient."
Hayes GTE addresses these issues by providing independent, evidence-based assessments of genetic tests. These unbiased evaluations provide important information for insurers, hospitals, and policy makers to consider when making decisions regarding the use of these genetic tests in the clinical setting.
About Hayes, Inc.
Hayes, Inc. provides unbiased, evidence-based research and analysis to help insurers, hospitals, and policy makers make informed healthcare decisions. The company's conclusions are independent, impartial, and objective, formulated by an international staff of medical analysts drawn from a range of healthcare disciplines.
Hayes research products and advisory services are used by some of the world's leading healthcare organizations. More than 65% of U.S. healthcare insurers serving approximately 150 million lives depend on Hayes research when developing coverage policies. In addition, Hayes research also supports hospitals making health technology acquisition decisions and employers helping employees make better informed healthcare choices.
Hayes, Inc. was founded by Winifred S. Hayes, PhD, in 1989 and is headquartered in suburban Philadelphia.
Hayes, Inc.