Health Problem: Rheumatoid arthritis (RA) is a chronic, progressive, systemic inflammatory disease leading to destruction of joint cartilage and bone, with consequent disability. This disease affects > 1.3 million people in the United States and > 4 million persons worldwide. Several new disease-modifying antirheumatic drugs (DMARDs) have bee…
Molecular Test Assessments
Molecular Test Assessments are comprehensive health technology assessments of molecular tests across a range of conditions and applications. Each report provides a clear, objective view of the science behind a specific molecular test, the clinical evidence supporting the test, the manufacturer, an explanation of how the test is used in clinical practice, and appropriate patient selection criteria.
These reports include the Hayes Rating to indicate the overall strength and direction of the body of evidence for the molecular test. Molecular Test Assessments provide evidence-based support for the development of coverage policy, utilization management, and evidence-based clinical practices. Reports are reviewed annually up to 5 years post publication to determine if there is new literature or evidence that would impact a change in rating and warrant an updated report.
EndoPredict (Myriad Genetics)
Breast cancer is the most common cancer in American women, with 1 in 8 women developing breast cancer during their lifetime in the United States. It is 1 of the most common forms of cancer, representing 14.6% of all new cancer cases in the United States, with an estimated 246,660 new cases of breast cancer diagno…
The Prostate Health Index for Prebiopsy Triage (Beckman Coulter)
In the United States, prostate cancer is the second most commonly diagnosed cancer (after skin cancers) and the third most common cause of cancer-related deaths in men. Approximately 1 in 7 men will be diagnosed with prostate cancer in his lifetime. It is estimated that 161,360 men will be diagnosed with prostate…
Fecal Calprotectin Assay for Monitoring Disease Activity in Crohn Disease
Purpose of Technology: Mucosal healing is emerging as a primary therapeutic target for Crohn disease (CD), as a growing body of evidence suggests that it is associated with better patient outcomes. The definitive standard for assessing intestinal inflammation is ileocolonoscopy; however, this technique is invasive, time-cons…
Fecal Calprotectin Assay for Monitoring Postoperative Recurrence of Crohn Disease
Purpose of Technology: Crohn disease (CD) patients require frequent monitoring after intestinal resection due to a high likelihood of postoperative recurrence. The reference standard for assessing endoscopic recurrence after ileocolonic resection is ileocolonoscopy; however, this technique is invasive, time consuming, expens…
GeneSight Psychotropic (Assurex Health Inc.)
Prescription drug use in the United States has steadily increased. Following this trend, pharmacotherapy for the treatment of neuropsychiatric disorders has also increased over the past several decades. According to a 2012 national survey, antidepressants were the third most commonly mentioned drug by therapeutic category at office visits. The benefit of prescription drug use has bee…
AlloMap (CareDx)
Heart transplantation is a widely accepted therapy for the treatment of end-stage cardiac disease. Approximately 20,000 people in the United States now live with a transplanted heart. Survival is nearly 90% at 1 year, 74.0% at 5 years, and the median survival is more than 10 years. Although long-term outcomes of cardiac transplantations have steadily improved, numerous life-threatening complic…
PancraGEN (Interpace Diagnostics)
The PancraGEN test is a molecular-based cancer diagnostic test that combines molecular genetic testing with current
An estimated 180,890 new cases of prostate cancer will be diagnosed in 2016, which accounts for 10.7% of all new cancer cases in the United States. Prostate cancer is the second leading cause of cancer death in the United States, with approximately 12.9% of men being diagnosed during their lifetime. For men diagnosed with prostate cancer from 2006 to 2012, the 5-year survival rate is 98.9%. Wh… Colorectal cancer (CRC) is one of the leading causes of cancer-related deaths in the United States. It is estimated that approximately 134,000 individuals will be diagnosed with CRC in 2016, and approximately 49,000 people will die from the disease. It is established that screening for CRC allows for the early detection and removal of cancers or precancerous …ProMark Proteomic Prognostic Test (Metamark Genetics Inc.)
Epi proColon (Epigenomics Inc.)