This report evaluates the analytical validity, clinical validity, and clinical utility of the Afirma Genomic Sequencing Classifier (Veracyte Inc.) test.
Afirma Genomic Sequencing Classifier (Veracyte Inc.)
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Publications
Researched and Curated by Clinical and Scientific Experts.Every Hayes clinical evidence report is developed by experienced teams that have been trusted by healthcare decision makers since 1989. Here is a sampling of our content that is being used every day to inform defensible, evidence-based decisions by payers and providers.
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Pattern Electroretinography for Diagnosis of Glaucoma
Focus of the Report: This report focuses on pattern electroretinography (PERG) for the diagnosis of glaucoma.
Technology Description: Early diagnosis of glaucoma can reduce the risk of irreversible vision loss and blindness. Electroretinography (ERG) is a minimally invasive procedure that provides an objective assessment of retinal function. PERG is a …
Portable Neuromodulation Stimulator for Gait Deficit in Multiple Sclerosis
The Portable Neuromodulation Stimulator (PoNS) device is a portable neuromodulation stimulator for short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis for use by prescription only as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older.
Finerenone for Diabetic Kidney Disease
Finerenone is an investigational nonsteroidal, selective mineralocorticoid receptor antagonist for treatment of patients with chronic kidney disease and type 2 diabetes.
Aquablation for Treatment of Benign Prostatic Hyperplasia
Focus of the Report: This report focuses on Aquablation therapy for the treatment of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH).
Technology Description: Aquablation therapy is a minimally invasive procedure that ablates overgrown prostatic tissue in order to restore patency to the urethral passageway. High-veloci…
Abecma (Idecabtagene Vicleucel) for Multiple Myeloma
Abecma (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Cologuard (Exact Sciences Corp.)
Focus of the Report: This report examines the analytical validity, clinical validity, and clinical utility of the Cologuard stool DNA test for the qualitative detection of colorectal neoplasia–associated DNA markers and for the presence of occult hemoglobin in human stool, which may indicate the presence of colorectal cancer (CRC) or advanced a…
Anifrolumab for Systemic Lupus Erythematosus
Anifrolumab is an investigational fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of all type I IFNs. It is proposed for the treatment of adults with moderately to severely active systemic lupus erythematosus (SLE) who are receiving standard care.
Glu-Plasminogen (Proposed Name: Ryplazim) for Congenital Plasminogen Deficiency
Ryplazim is an investigational intravenous plasminogen replacement therapy for treatment of congenital plasminogen deficiency in children and adults. Ryplazim is recovered from healthy donor plasma; plasminogen is extracted using a proprietary process. Purified isolated plasminogen is administered by intravenous infusion.
Mavacamten for Obstructive Hypertrophic Cardiomyopathy
Mavacamten is an investigational oral myosin inhibitor that targets the underlying molecular mechanisms of hypertrophic cardiomyopathy (HCM). It is proposed for the treatment of patients with symptomatic obstructive HCM.