Hayes Completes 150 Evidence-Based Analyses of Genetic Testing Applications

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Genetic Test Evaluation (GTE) Service highlights best clinical evidence for fast-growing genetic testing industry

Hayes, Inc., the nation's leading health technology research and consulting company, today announced that it has completed comprehensive evidence-based analyses of 150 applications for genetic testing. The Hayes Genetic Test Evaluation (GTE) Program was launched in February 2008. GTE reports address a wide range of applications, including cancer, pharmacogenetics, and neurological disorders, among others.

Demand for genetic and genomic testing continues to increase, driven by development of new tests as well as consumer interest in better healthcare. Today, 600 laboratories worldwide offer genetic testing for more than 1,700 inherited genetic disorders, and the number of tests continues to increase at breakneck speed.

With Hayes evidence-based GTE reports, genetic test laboratories have a unique opportunity to improve patient care and outcomes through application of evidence-based decision making. In addition, these tests represent a major growth opportunity for labs, and one that can drive business results for the foreseeable future. Delivering real evidence of effectiveness will catalyze this growth opportunity for the laboratory community, ensure adequate reimbursement and coverage policies, enhance relationships with constituents, and drive real improvements in diagnosis and treatment of disease.

Each Hayes GTE report provides a clear, objective view of the science behind a specific genetic test, the clinical evidence supporting the test, and the use of the test in clinical practice. With this research, clinical labs can pinpoint those tests that will have the biggest impact for payers, providers, and patients. In turn, this will unleash a range of benefits, including: better provider relationships; reputation as a trustworthy laboratory focused on real clinical evidence; improved coverage and reimbursement results; and elimination of testing that does not drive real results in improving healthcare.

Hayes also offers labs a cross-functional team of clinicians to help incorporate the Hayes research into their clinical practice. The Hayes GTE Team is composed of three medical analysts with doctorates in genetics or another related discipline, and one analyst is a certified genetic counselor. The program's director, Dr. Diane Allingham-Hawkins, is a laboratory geneticist with more than 12 years of experience and dual-certification in molecular genetics and cytogenetics by the Canadian College of Medical Geneticists.

For all reviewed tests, the GTE team continuously monitors the literature for any developments that may affect the Hayes Rating for any assessed application, and all tests are formally reviewed at least once a year. Examples of tests reviewed by the GTE Program to date are:

  • AlloMap® Molecular Expression (XDx Inc.) for Detection of Heart Transplant Rejection
  • Ashkenazi Jewish Genetic Screening Panel
  • Comparative Genomic Hybridization (CGH) Microarray Testing for Chromosomal Imbalances
  • deCODE MI™
  • CYP2C9 and VKORC1 Variant Testing for Management of Warfarin Dose Initiation

The goal for 2009 is to perform health technology assessments on 40 to 50 new genetic or genomic tests. Examples of tests currently under review by the GTE Program are:

  • CYP2C19 Genotyping to Determine Response to Clopidogrel
  • deCODE BreastCancer™
  • Hereditary Non-Polyposis Colon Cancer/Lynch Syndrome
  • SPOT-Light® HER2 CISH Kit (Invitrogen Corp.) for Assessing Eligibility for Herceptin® (Trastuzumab) Treatment
  • TheraGuide 5-FU™ (Myriad Genetics) for Predicting Toxicity to 5-Fluorouracil (5-FU)/Capecitabine-Based Chemotherapy

For more information about the Hayes GTE Program and to view sample GTE reports, please visit the Hayes, Inc. website at http://www.hayesinc.com/hayes/ .

Hayes, Inc.

Hayes, Inc. is an independent health technology research and consulting company dedicated to promoting better health outcomes. Hayes performs unbiased, evidence-based health technology assessments of the safety and efficacy of new, emerging, and controversial health technologies, and evaluates the impact of these technologies on healthcare quality, utilization, and cost. Hayes' worldwide clients include hospitals, healthcare systems, government agencies, employers, and managed care organizations.

Hayes products and services include:

  • A dynamic, web-based health technology assessment Knowledge Center designed to support professionals who are responsible for strategic planning, technology acquisition, and policy development.
  • Consulting services that enhance strategic technology planning and support evidence-based technology acquisition so that hospitals can anticipate and prepare for the financial, clinical, and operational impact of new technologies prior to their adoption.
  • Customized services that help payers develop and update coverage policies as well as create clinical guidelines.
  • Employee benefit programs that help patients make well-informed decisions about healthcare options.

For more information, visit http://www.hayesinc.com/hayes/ .

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