Corporate Banner
Satellite Banner
Genotyping & Gene Expression
Scientific Community
Become a Member | Sign in
Home>News>This Article

Veracyte Receives New York State License for Afirma® Gene Expression Classifier

Published: Wednesday, September 12, 2012
Last Updated: Tuesday, September 11, 2012
Bookmark and Share
Veracyte and Genzyme also announce that Memorial Sloan-Kettering Cancer Center is among the state's first institutions to offer genomic test to patients with inconclusive thyroid nodule results.

Veracyte, Inc. and Genzyme have announced that the New York State Department of Health has issued a license enabling Veracyte's Afirma® Gene Expression Classifier to be offered to patients in the state.

The companies also announced that Memorial Sloan-Kettering Cancer Center will become one of the first medical institutions in the state to offer patients the genomic test, which helps resolve inconclusive thyroid nodule results following traditional evaluation of fine needle aspiration (FNA) samples.

"We are delighted that the Afirma Gene Expression Classifier will now be available to physicians and their patients in New York State and that Memorial Sloan-Kettering is among the first in the state to offer our test," said Bonnie Anderson, Veracyte's cofounder and chief executive officer.

Anderson continued, "These milestones underscore the clinical need for and strength of the clinical data behind our test. Our goal is to help identify patients whose thyroid nodules are actually benign so that they may avoid unnecessary, invasive surgery."

Thyroid cancer is the fastest-increasing cancer in the United States, with 56,460 new cases expected in 2012, according to the American Cancer Society.

Approximately 450,000 thyroid nodule FNAs - a minimally invasive procedure to extract cells for examination under the microscope - are performed each year in the U.S. to rule out cancer.

Up to 30% of the time, the results are inconclusive, and current protocols typically recommend thyroid surgery for final diagnosis. Following surgery, however, 70-80% of patients turn out to have benign nodules.

The Afirma Gene Expression Classifier measures the expression of 142 genes to reclassify ambiguous thyroid FNA samples as either benign or suspicious for cancer.

A clinical validation study, published recently in the New England Journal of Medicine, showed that when applied to the major categories of indeterminate thyroid samples, the test reclassified the samples as benign with greater than 94% accuracy.

The Afirma Gene Expression Classifier is offered as part of Veracyte's comprehensive Afirma Thyroid FNA Analysis, which combines specialized cytopathology assessment for initial review of thyroid nodule FNAs, with the gene expression test used to clarify inconclusive results.

The test is now covered for Medicare patients nationwide and is available throughout the U.S. through a global co-promotion partnership with Genzyme, a Sanofi company and one of the world's leading biotechnology companies.

"We look forward to bringing to New York endocrinologists and thyroid patients a complete solution, which includes the Afirma Thyroid FNA Analysis for thyroid nodule assessment and Thyrogen® for the management of patients diagnosed with thyroid cancer," said Alicia Secor, Genzyme's vice president and general manager of Endocrinology.

Genzyme is an established leader in endocrinology globally, developing and marketing Thyrogen® (thyrotropin alfa for injection) for patients with well-differentiated thyroid cancer.

Thyrogen® is used as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow up of patients with well-differentiated thyroid cancer.

Thyrogen® is also approved in the U.S. and Europe as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Veracyte to Acquire Allegro Diagnostics
Plans to launch lung cancer test in the second half of 2015, with meaningful revenue expected in 2017.
Tuesday, September 09, 2014
Scientific News
Genetic Basis of Fatal Flu Side Effect Discovered
A group of people with fatal H1N1 flu died after their viral infections triggered a deadly hyperinflammatory disorder in susceptible individuals with gene mutations linked to the overactive immune response, according to a recent study.
New Class of RNA Tumor Suppressors Identified
Two short, “housekeeping” RNA molecules block cancer growth by binding to an important cancer-associated protein called KRAS. More than a quarter of all human cancers are missing these RNAs.
Mathematical Model Forecasts the Path of Breast Cancer
Chances of survival depend on which organs breast cancer tumors colonize first.
Ancient Viral Molecules Essential for Human Development
Genetic material from ancient viral infections is critical to human development, according to researchers at the Stanford University School of Medicine.
Measuring microRNAs in Blood to Speed Cancer Detection
A simple, ultrasensitive microRNA sensor holds promise for the design of new diagnostic strategies and, potentially, for the prognosis and treatment of pancreatic and other cancers.
Personalized Drug Screening for Multiple Myeloma Patients
A personalized method for testing the effectiveness of drugs that treat multiple myeloma may predict quickly and more accurately the best treatments for individual patients with the bone marrow cancer.
Metabolic Profiles Distinguish Early Stage Ovarian Cancer with Unprecedented Accuracy
Studying blood serum compounds of different molecular weights has led scientists to a set of biomarkers that may enable development of a highly accurate screening test for early-stage ovarian cancer.
New Way to Force Stem Cells to Become Bone Cells
Potential therapies based on this discovery could help people heal bone injuries or set hardware, such as replacement knees and hips.
Promise of Newborn Stem Cells to Revolutionize Clinical Practice
In this article Shweta Sharma, PhD, discusses the potential of an Umbilical Cord Blood bank as an untapped source of samples for research and clinical trials.
New Anti-Malarial Drug Screening Model
University of South Florida researchers demonstrate novel chemogenomic profiling to identify drug targets for the most lethal strain of malaria.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos